14,154 records
Is this firm on an FDA import alert red list?
14,154 records covering 13,081 firms, one fact each. Every value is transcribed from the source that states it and carries the sentence it was taken from: 31 sources across 1 site, last checked 2026-09-16, due for re-check by 2026-11-15. Every record has a page of its own, quoting the line that states it.
Records14,154
Sources31
Verified
Review by
LicenceFacts extracted from FDA's freely published import alert pages on accessdata.fda.gov. US government work; firm names, addresses, product codes, publication dates and FDA's stated reasons are facts and not copyrightable. Each record links back to the import alert page it was read from. Note the disclaimer FDA prints on every alert and which every record page should carry: 'This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.'
Recent changes
- 32 records added or updated
- 12,819 records added or updated
- 1 record added or updated
- 10 records added or updated
- 10 records added or updated
Full change history · Atom feed
About this data
Which foreign manufacturers, shippers and growers are on an FDA import alert red list, meaning every shipment from them is detained without physical examination (DWPE) at the US border. Each record is one firm on one import alert, with the firm name and address as FDA prints it, the country, the date FDA published the listing, and the product codes and product descriptions it covers. Answers 'is my supplier on an FDA import alert', 'is [firm] on the red list for import alert 66-41', 'why was my shipment detained without examination', 'which firms are on the FDA red list for undeclared pharmaceutical ingredients in supplements', and 'how do I check a Chinese manufacturer before ordering'. FDA publishes 153 separate import alerts as individual current-state pages with no cross-alert firm index, so answering 'is this firm flagged anywhere' means opening 153 pages; and firms are removed from red lists on petition with no record of the removal published at all, so an assistant answering from memory names firms that were delisted years ago.
The data
| Firm | Import alert | Import alert name | Country | Address | Date published | Product code | Product | FDA notes |
|---|---|---|---|---|---|---|---|---|
| Afghan Attaran Food & Beverage Company | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Mahalleh-E-Naw Road 85 Mw , Herat, Herat AFGHANISTAN | 08/31/2022 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | 02 D - - 07 Rice, Basmati, Processed (Packaged) | Basmati Rice | Basmati Rice | TEBUCONAZOLE; | TEBUCONAZOLE; |
| Arizo Zeba LLC | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Np.55170 Mandawi Kocha Baghbanan Markaz , Kabul, Kabul AFGHANISTAN | 05/17/2022 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | 21 G - - 14 Plum (Pit Fruit) | 21 G - - 99 Pit Fruit, N.E.C. | 21 T - - 03 Fig, Dried or Paste | Green Raisins | Green Raisins | Figs | Figs | Figs | LAMBDA-CYHALOTHRIN; CHLORFENAPYR; | CHLORFENAPYR; LAMBDA-CYHALOTHRIN; | ETHION; CLOFENTEZINE; SPIRODICLOFEN; | CLOFENTEZINE; ETHION; SPIRODICLOFEN; | CLOFENTEZINE; ETHION; SPIRODICLOFEN; |
| Arman Ghostar Shargh Company Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Shahr Now Mojtama 1 , Herat, AFGHANISTAN | 12/24/2015 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | Raisins | Raisins | CHLORPYRIFOS; | CHLORPYRIFOS; |
| Ashk Co Limited | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Olympia Business Centre , 1st Part of Jada-E-Maiwand , Kabul, AFGHANISTAN | 05/02/2017 | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 99 Berries, Dried or Paste, N.E.C. | 21 H - - 03 Cherry, Dried or Paste | 21 S - - 03 Fig (Subtropical and Tropical Fruit) | Green Raisins | Red Raisins | Green Raisins | Red Raisins | Dried Red Berries | Sour Cherry | Fig | CYROMAZINE; THIODICARB; TETRAMETHRIN; | LUFENURON; | LUFENURON; LAMBDA-CYHALOTHRIN; | THIODICARB; | CARBARYL; MALATHION; | Problem: PHOSALONE | FENITROTHION; | ETHION; CLOFENTEZINE; BROMOPROPYLATE; SPIRODICLOFEN; |
| HAJI BASHIR AHMAD LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Charagh Ali Market , Kabul, AF-KAB AFGHANISTAN | 04/20/2013 | 20 B - - 10 Raisins, Dried or Paste | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | Jumbo Black Raisins | Dried Dates (Zahedi Dates) | Sample #797173 | FLUSILAZOLE; | FENPYROXIMATE, E-; |
| IRFAN AHMAD LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Office No 1 , District 14 Lane No 102 , Kandahar, Kandahar AFGHANISTAN | 09/19/2025 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | RED RAISINS | Green raisins | Green raisins | RED RAISINS | Green raisins | RED RAISINS | ESFENVALERATE; | PENCONAZOLE; LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; PENCONAZOLE; | ESFENVALERATE; | PENCONAZOLE; LAMBDA-CYHALOTHRIN; | ESFENVALERATE; |
| KABUL BABA JAAN MANUFACTURE AND PACKAGING OF DRIED FRUIT | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | House No 16, Street 8, Shura Road , Kabul, Kabul AFGHANISTAN | 01/27/2025 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 21 Barberry | 20 B - - 05 Currants Black, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 28 Currants, Red, Dried or Paste | 23 A - - 11 Pistachio, In Shell | Dried Red Raisins | Dried Green Raisins | Dried Currants | Dried Currants | Dried Green Raisins | Dried Red Raisins | Dried Currants | Pistachios | CHLOROTHALONIL; LUFENURON; | LAMBDA-CYHALOTHRIN; Thifluzamide; PROCYMIDONE; LUFENURON; | DIMETHOATE; | DIMETHOATE; | Thifluzamide; PROCYMIDONE; LAMBDA-CYHALOTHRIN; LUFENURON; | LUFENURON; CHLOROTHALONIL; | DIMETHOATE; | CLOTHIANIDIN; CHLORPYRIFOS; THIAMETHOXAM; |
| Khaddam Group Co Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Maidan Hawayee , Opposite Of Shahrak Aria , Kabul, AFGHANISTAN | 03/11/2024 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 28 Currants, Red, Dried or Paste | 26 C - - 10 Flaxseed/Linseed Oil, Refined, Single Ingredient | BLACK RAISINS | Green Raisins | Green Raisins | Green Raisins | Flaxseed Oil | PENCONAZOLE; | LAMBDA-CYHALOTHRIN; HEXACONAZOLE; | HEXACONAZOLE; LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; HEXACONAZOLE; | LAMBDA-CYHALOTHRIN; TEBUCONAZOLE; |
| Khalid Walid Ghalibi Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Shadiyan Road, Dry Fruit Main Market , Mazar-E Sharif, AFGHANISTAN | 08/23/2022 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | Red Raisins | Sunderkhani Raisins; Green raisins | Black raisins | Red Raisins | Black raisins | Black raisins | Red Raisins | Sunderkhani Raisins; Green raisins | CHLORPYRIFOS; | LAMBDA-CYHALOTHRIN; HEXACONAZOLE; | PENCONAZOLE; | CHLORPYRIFOS; | LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; PENCONAZOLE; | CHLORPYRIFOS; | HEXACONAZOLE; LAMBDA-CYHALOTHRIN; |
| Life Pharma | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Khalid Taraki Business Center , Office No.7; Parwan Hotel Khir Khana 3 , Kabul, AFGHANISTAN | 05/08/2025 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 99 Berries, N.E.C. | 20 B - - 10 Raisins, Dried or Paste | Raisins; Dried | Raisins; Dried | Raisins; Dried | CHLORPYRIFOS; LAMBDA-CYHALOTHRIN; PENCONAZOLE; | CHLORPYRIFOS; LAMBDA-CYHALOTHRIN; PENCONAZOLE; | CHLORPYRIFOS; LAMBDA-CYHALOTHRIN; PENCONAZOLE; |
| MURVARID ARIA TRADING CO | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Majidi Street, 6th District , Herat, Herat AFGHANISTAN | 07/06/2026 | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | Green Sandal Khani Raisins | Round Green Raisins | Long Green Raisins | Large Red Raisins | CHLORPYRIFOS; PROFENOFOS; | LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; | CHLORPYRIFOS; |
| NANA TRADING COMPANY | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Ansari Road Kolola Pushta 4th , Kabul, AFGHANISTAN | 07/03/2025 | 07 H - - 99 Fruit Snack Foods, n.e.c., Fried/Oil Cooked | 20 B - - 19 Haw, Dried or Paste | Red Raisins | Red Raisins | LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; |
| Nazo Afghan | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Sari Saidak, Hazratjee Baba , Kandahar, AF-KAN AFGHANISTAN | 02/04/2026 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 28 Currants, Red, Dried or Paste | Red Raisins | Red Raisins | LAMBDA-CYHALOTHRIN; PENCONAZOLE; | LAMBDA-CYHALOTHRIN; PENCONAZOLE; |
| PAHEZ ROSTA TRADING | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Bagh Qazi 36130 , Kabul, AFGHANISTAN | 04/30/2019 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | Green Raisins | Green Raisins | PROCHLORAZ; | PROCHLORAZ; |
| Pahez Rosta Trading Company | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | House 1, Bagh Kaze , District 1 , Kabul, Kabul AFGHANISTAN | 07/02/2024 | 20 A - - 21 Barberry | DRIED BARBERRIES | CHLORPYRIFOS; MALATHION; IMIDACLOPRID; |
| RUMI TRADING LLC | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | House No 17, Burj Barq Street, Kolola Pushta Road, Pd 4 , Kabul, Kabul AFGHANISTAN | 08/20/2024 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 04 Cranberries, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 37 D - - 99 Stew, n.e.c. | Raisins | Raisins | Raisins | Raisins | ETHION; | ETHION; | ETHION; | ETHION; |
| SALEH RAOUFIL LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | T.L/E 27-423 , Kandahar, AFGHANISTAN | 01/09/2026 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | Green raisins | Green raisins | Green raisins | LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; | LAMBDA-CYHALOTHRIN; |
| Tabasom Raisin Processing Factory | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | Bagram Road , Industrial Park Pul-E-Charkhi , Kabul, AF-KAB AFGHANISTAN | 08/03/2010 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | 618467 NYK-DO | Raisins | DIMETHOATE; LAMBDA-CYHALOTHRIN; | 618467 NYK-DO | DIMETHOATE; LAMBDA-CYHALOTHRIN; |
| Zeyaratjah trading | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | District No. 3 , Herat, AFGHANISTAN | 11/15/2018 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 99 Berries, Dried or Paste, N.E.C. | 23 B - - 11 Pistachio, Shelled | GREEN RAISINS | Dry Red Berries | Pistachio | CHLORPYRIFOS; | DICOFOL, O,P'-; PHOSALONE; | IMIDACLOPRID; CHLORPYRIFOS; |
| Zia Zafar Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AFGHANISTAN | T.L No: 0601-484 Sarai Shehzada First Zone , Jalalabad, Nangarhar AFGHANISTAN | 11/04/2024 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 10 Raisins, Dried or Paste | Red Raisins | Green Raisins | Green Raisins | Red Raisins | Green Raisins | PENCONAZOLE; | LAMBDA-CYHALOTHRIN; CHLORPYRIFOS; | LAMBDA-CYHALOTHRIN; | PENCONAZOLE; | CHLORPYRIFOS; |
| Mohamad Mahroof & Mahmood Haidar | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AFGHANISTAN | Bazaar Kandharyellow Carvansera , Herat, AFGHANISTAN | 11/07/2014 | 24 T - - 99 Leaf & Stem Vegetables, N.E.C. | 28 A - - 56 Fenugreek, Whole (Spice) | 28 B - - 99 Spices, Ground, Cracked, Etc., N.E.C. | 28 Y - - 99 Spices, Flavors and Salt Not Mentioned Elsewhere, N.E.C. | 54 F - - 45 Fenugreek (Herbal & Botanicals, not Teas) | Fenugreek Leaves (Dried) | Fenugreek Leaves (Dried) | Fenugreek Leaves (Dried) | Fenugreek Leaves (Dried) | Fenugreek Leaves (Dried) | |
| Afghanistan Red Gold Saffron Company | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Metra Street District 5 64 , Sadeq 33 , Herat, AFGHANISTAN | 08/21/2018 | 21 H - - 01 Apricot, Dried or Paste | Dried Apricot | SULFUR DIOXIDE; |
| Arizo Zeba LLC | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Np.55170 Mandawi Kocha Baghbanan Markaz , Kabul, Kabul AFGHANISTAN | 06/03/2022 | 21 G - - 01 Apricot (Pit Fruit) | 21 H - - 01 Apricot, Dried or Paste | Dried Apricot | Dried Apricot | SULFUR DIOXIDE; | SULFUR DIOXIDE; |
| Charagh Ali Market | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | District 1 , Kabul, AFGHANISTAN | 11/16/2012 | 20 B - - 18 Mulberry, Dried or Paste | 21 H - - 01 Apricot, Dried or Paste | Dried Black Mulberry | Dried Sliced Apricot | |
| HAJI BASHIR AHMAD LTD | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Charagh Ali Market , Kabul, AF-KAB AFGHANISTAN | 01/04/2017 | 21 H - - 01 Apricot, Dried or Paste | Whole Apricot | SULFUR DIOXIDE; |
| Hamza Jalili Company | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Darwazi Shadyan Industrial Park , Mazar-e Sharif, AF-NOTA AFGHANISTAN | 01/08/2016 | 21 H - - 01 Apricot, Dried or Paste | Dried Apricot with Seeds | Problem: Undeclared Sulfites |
| Ismail Zade General Trading | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Plot #1 Ghomandani Street , Herat, AFGHANISTAN | 12/19/2018 | 21 H - - 01 Apricot, Dried or Paste | Mini Dried Apricots | |
| KABUL BABA JAAN MANUFACTURE AND PACKAGING OF DRIED FRUIT | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | House No 16, Street 8, Shura Road , Kabul, Kabul AFGHANISTAN | 03/19/2025 | 21 H - - 01 Apricot, Dried or Paste | 21 H - - 01 Apricot, Dried or Paste | Twisted Slice Apricots | Apricot leaf (saqi) | SULFUR DIOXIDE; | SULFUR DIOXIDE; |
| Khalid Walid Ghalibi Ltd | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Shadiyan Road, Dry Fruit Main Market , Mazar-E Sharif, AFGHANISTAN | 04/11/2025 | 20 B - - 09 Grapes, Dried or Paste | 20 B - - 99 Berries, Dried or Paste, N.E.C. | 21 H - - 14 Plum, Dried or Paste | Dried Plum | Dried Plum | Dried Plum | Problem(s); Sulfites; undeclared | Problem(s); Sulfites; undeclared | Problem(s); Sulfites; undeclared |
| MUSLIM CHAKARI TRADING COMPANY | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | Maiwand Avenue , Kabul, AFGHANISTAN | 08/13/2025 | 21 H - - 01 Apricot, Dried or Paste | Dried Apricots | SULFUR DIOXIDE; |
| Pahez Rosta Trading Company | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | House 1, Bagh Kaze , District 1 , Kabul, Kabul AFGHANISTAN | 07/02/2024 | 21 H - - 15 Prunes (Dried Plums), Dried or Paste | Dried Plums | Label does not declare sulfites | SULFUR DIOXIDE; |
| Zia Zafar Ltd | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | AFGHANISTAN | T.L No: 0601-484 Sarai Shehzada First Zone , Jalalabad, Nangarhar AFGHANISTAN | 07/17/2023 | 21 H - - 01 Apricot, Dried or Paste | Apricots | Entries for this firm have been made using alternative spelling for the firm, “Zeya Zaffar LTD”, at the same address. | SULFUR DIOXIDE; |
| HAJI BASHIR AHMAD LTD | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AFGHANISTAN | Charagh Ali Market , Kabul, AF-KAB AFGHANISTAN | 02/03/2017 | 21 H - - 01 Apricot, Dried or Paste | 21 H - - 14 Plum, Dried or Paste | Whole Apricot | Dried Plum | Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient . Section 403(f) of the FD&C Act in that the product label contains information in foreign languages but does not present all information required by the Act in all languages. | Section 403(q) of the FD&C Act in that the label or labeling fails to bear the required nutrition information. |
| IRFAN AHMAD LTD | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AFGHANISTAN | Office No 1 , District 14 Lane No 102 , Kandahar, Kandahar AFGHANISTAN | 12/18/2025 | 04 C - - 99 Noodles And Noodle Products, N.E.C. | 04 Y - - 99 Macaroni/Noodle Products Not Elsewhere Mentioned, N.E.C. | Fried Semian Noodles (Sieman/Simyan/Semain) | Fried Semian Noodles (Sieman/Simyan/Semain) | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)]. All mandatory label information appears in English, therefore, the provision under 21 CFR 101.15(c)(1) is not applicable. Section 403(i)(2) [21 U.S.C. § 343(i)(2)], because the ingredient statement is not in accordance with 21 CFR 101.4. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)]. All mandatory label information appears in English, therefore, the provision under 21 CFR 101.15(c)(1) is not applicable. Section 403(i)(2) [21 U.S.C. § 343(i)(2)], because the ingredient statement is not in accordance with 21 CFR 101.4. |
| RASHKO BABA | 99-45 | Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive | AFGHANISTAN | 5th District Comapny Square Baghedawood Road , Kabul, AFGHANISTAN | 03/24/2022 | 52 A - - 54 Soup Pan/Pot, Roasting Pan, etc (Deep item capable of holding liquid w/ or w/o lid) Food/Cook/Table | 52 A - - 99 Kitchen and Tableware, n.e.c., (Foodware, Cookware & Tableware) | Pressure cooker | Pressure cooker | LEAD; | LEAD; |
| RASHKO BABA CO LTD | 99-45 | Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive | AFGHANISTAN | Eno D 21353 , Jalalabad, AFGHANISTAN | 03/24/2022 | 52 A - - 54 Soup Pan/Pot, Roasting Pan, etc (Deep item capable of holding liquid w/ or w/o lid) Food/Cook/Table | 52 A - - 99 Kitchen and Tableware, n.e.c., (Foodware, Cookware & Tableware) | Pressure cooker | Pressure cooker | LEAD; | LEAD; |
| FEDERATA BUJQESORE ELBASAN | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALBANIA | Shirgjan , Elbasan, ALBANIA | 08/13/2024 | 26 A - - 09 Virgin Olive Oil, Crude | 26 C - - 04 Olive Oil, Refined, Single Ingredient | Olive Oil | Olive Oil | CHLORPYRIFOS; | CHLORPYRIFOS; |
| LULZIM BAXHIA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALBANIA | Rruga Nacionale Velmisht , Fier, Al-04 ALBANIA | 05/06/2022 | 21 G - - 11 Olives, Green, (Pit Fruit) | Green Olives | IMIDACLOPRID; |
| Alb Ducros | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Rr Budi 73 , Tirana, Al-Tr ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | 7/14/05 | SALMONELLA; | 7/14/05 | SALMONELLA; | |
| Filipi Company Shpk | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Factory Sanxhak- Lac / Albania , Lac, Lac ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 2/14/01 | SALMONELLA; | |
| Gjedra | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Ish Ushqimore Street , Berat, Berat ALBANIA | 12/17/2018 | 28 A - - 41 Sage, Whole (Spice) | WHOLE DRIED SAGE | |
| Gjedra Sh.P.K. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Deshmoret E Kombit , Berat, ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | 1/21/04 | SALMONELLA; | 1/21/04 | SALMONELLA; | |
| Herbs & Flowers Sh.P.K. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Po Box 1553 , Street 4 Shkurti No. 6 , Tirana, ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | 8/10/06 | SALMONELLA; | 8/10/06 | SALMONELLA; | |
| Interagra Sh.P.K.Export Botanical & Aromatic Pl | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Gjorm , Kurbin, ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | 12/22/01 | SALMONELLA; | 12/22/01 | SALMONELLA; | |
| Natural Products SHPK | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | 127/7 Nikolla Lena St. , Tirana, Tirana - District ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | ground; whole and rubbed sage | ground; whole and rubbed sage | 8/23/07 | SALMONELLA; | 8/23/07 | SALMONELLA; |
| Naturepure Sh.P.K. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Shkurti No.21/5 , Tirana, ALBANIA | 09/16/2009 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | dried sage | dried sage | 7/31/03 | SALMONELLA; | 7/31/03 | SALMONELLA; |
| ORLANDO S.H. P.K. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Zona Industriale , Shkober, Shkoder - County ALBANIA | 06/02/2010 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | Sage | Sage | SALMONELLA; | SALMONELLA; |
| Zagora Shpk | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ALBANIA | Koplik, Malesi Madhe, Bogic Palvar , KM 25 , Shkoder, Shkoder ALBANIA | 08/29/2018 | 28 A - - 41 Sage, Whole (Spice) | 28 B - - 41 Sage, Ground, Cracked (Spice) | Sage; Dried | Sage; Dried | SALMONELLA; |
| ZDRAVO | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | ALBANIA | Lagjia Xhevdet Nepravishta Godina, 20 , Lushnje, Lushnje ALBANIA | 06/28/2023 | 24 F - - 07 Pepper, Sweet (Fruit Used as Vegetable) | 24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable) | 25 E - - 14 Tzahp Choy (Chinese Canned Sweet Pickles made from Mixed Vegetables) (Mixed Vegetables) | Cherry Peppers filled with cottage cheese | Cherry Peppers filled with cottage cheese | Cherry Peppers filled with cottage cheese | No scheduled process on file | No scheduled process on file | No scheduled process on file |
| APOLLO TRADE | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | Centre Commercial Et Daffairs El Qods Lot N1505 Bureau C1801 Nive , Cheraga, Alger ALGERIA | 03/14/2023 | 24 A - - 06 Garbanzo Bean | 24 B - - 06 Garbanzo Bean, Dried or Paste | Chickpea Flour | Chickpea Flour | PIRIMIPHOS-METHYL; | PIRIMIPHOS-METHYL; |
| BENSAHAL RIDHA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | Rte De Sahara Farfar , Tolga, Biskra ALGERIA | 12/05/2025 | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | 21 G - - 06 Stuffed Dates (Pit Fruit) | 21 H - - 05 Dates, Dried or Paste | 21 H - - 06 Stuffed Dates, Dried or Paste | 21 L - - 06 Stuffed Dates, Topping or Syrup | Algerian Deglet Nour Dates | Algerian Deglet Nour Dates | Algerian Deglet Nour Dates | Algerian Deglet Nour Dates | Algerian Deglet Nour Dates | SPIROMESIFEN; | SPIROMESIFEN; | SPIROMESIFEN; | SPIROMESIFEN; | SPIROMESIFEN; |
| ETS HADDOUD SALIM | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | Industrial Zone Tolga , Tolga, Biskra ALGERIA | 05/22/2019 | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | 21 G - - 06 Stuffed Dates (Pit Fruit) | 21 H - - 05 Dates, Dried or Paste | 21 H - - 06 Stuffed Dates, Dried or Paste | DEGLET NOUR DATES | DEGLET NOUR DATES | DEGLET NOUR DATES | DEGLET NOUR DATES | DIFLUBENZURON; PIRIMIPHOS-METHYL; | DIFLUBENZURON; PIRIMIPHOS-METHYL; | DIFLUBENZURON; PIRIMIPHOS-METHYL; | DIFLUBENZURON; PIRIMIPHOS-METHYL; |
| HAMMOUD BOUALEM | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | 201, Rue Hassiba , Algiers, ALGERIA | 08/04/2021 | 02 F - - 07 Wheat, Milled (Crushed, Coarse Ground or Cracked) | FRIK | PIRIMIPHOS-METHYL; |
| O & D Office National Del A Dattess | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | unknown , Beskra, ALGERIA | 09/16/2009 | 21 H - H 05 Dates, Dried or Paste, Ntrl/Artfcl Dried | dried dates | 3/16/98 | LINDANE; |
| Sarl Agro Delights | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | Rue Makhlouf Saad , Biskra, Biskra ALGERIA | 03/22/2019 | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | DEGLET NOUR DATES | TEBUCONAZOLE; PIRIMIPHOS-METHYL; |
| Sarl Tolga Agro Food | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ALGERIA | 17, Route De Touggourt , Tolga, Biskra ALGERIA | 04/01/2024 | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | DATES DEGLET NOUR | SPIROMESIFEN; |
| ETS HADDOUD SALIM | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | ALGERIA | Industrial Zone Tolga , Tolga, Biskra ALGERIA | 07/12/2016 | 21 G - - 05 Dates (Pit Fruit), (Pit Fruit) | Dates | Sulfur Dioxide - undeclared sulfites | SULFUR DIOXIDE; |
| SARL FABRICATION DE PRODUITS ALIMENTAIRES CEBON | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | ALGERIA | Cite Merdji , Fouka, Tipaza ALGERIA | 01/25/2022 | 36 A - - 99 Sugar Products, N.E.C. | 36 B - - 08 Sugar Syrup, Beet and Cane (Liquid Sucrose, Simple Syrup) | 36 C - - 04 Honey | Succedane de Miel (Honey substitute) | Succedane de Miel (Honey substitute) | Succedane de Miel (Honey substitute) | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) because the label fails to provide required information in English, such as, the statement of identity and “net weight” in accordance with section 21 CFR 101.15(c)(1). Section 403(q) because the Nutrition Facts label is not in accordance with the requirements in section 21 CFR 101.9. Section 403(e)(2) of the Act and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) for the failure of the label to declare the net quantity of contents in avoirdupois pounds and ounces, per section 21 CFR 101.7. |
| World Pharmacy, Inc. (Mr. Roger Pemberton) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ANTIGUA & BARBUDA | Hodges Bay , St. John (West Indies), ANTIGUA & BARBUDA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 ;The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Ardapez SA | 16-04 | Detention Without Physical Examination of Seafood Products That Appear To Be Misbranded | ARGENTINA | Avenida Virrey Vertiz 3250 , Mar Del Plata, Buenos Aires ARGENTINA | 08/16/2019 | 16 A - - 30 Porgy | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Red Snapper | Red Snapper | The product label on the outside container identifies the species of fish as "Red Snapper". | The product label on the outside container identifies the species of fish as "Red Snapper" |
| Isla de los Estados S.A. | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | ARGENTINA | Ruta Nacional 2 Km 367.5 , Mar Chiquita , Vivorata, Buenos Aires ARGENTINA | 08/25/2025 | 16 A - - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, Etc.) | 16 A - - 47 Weakfish (Sea Trout) | Sea Trout; Cynoscion Guatucupa; Stripped Weakfish | Sea Trout; Cynoscion Guatucupa; Stripped Weakfish | Problem(s): Decomposition | Problem(s): Decomposition |
| Pesquera Costa Brava S.R.L. | 16-119 | "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations" | ARGENTINA | Calle 1002 Esq.1003 Puerto Mar De Plata , Buenos Aires, ARGENTINA | 03/29/2011 | 16 A - - 13 Croaker | 16 A - - 13 Croaker | 16 A - - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, Etc.) | Frozen Yellow Croaker | Frozen White Croaker | Frozen Sea Trout | Importer; Gold Coast Trading Co. FEI #1000299910; | Importer; Gold Coast Trading Co. FEI #1000299910; | Importer; Gold Coast Trading Co. FEI #1000299910; |
| MOLECULAR DYNAMICS SAS | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | ARGENTINA | Malabia 1177 , Buenos Aires, ARGENTINA | 03/12/2024 | 54 A - - 99 Vitamin, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | XHUM Monarch Sexual Enrichment Supplement | XHUM Monarch Sexual Enrichment Supplement | FDA laboratory analysis confirmed product contains undeclared tadalafil. | FDA laboratory analysis confirmed product contains undeclared tadalafil. |
| Guillermo Rivera | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | ARGENTINA | Calle Chivilcoy 4820 , Ciudad Autonoma Buenos Aires, Buenos Aires ARGENTINA | 09/30/2009 | 64 X - - 11 Isotretinoin (Keratolytic) | 2/8/2007 | |
| OP Online-Pharmacy.cc | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | ARGENTINA | Online Pharmacy SA, Corrientes 1820 , Buenos Aires , Capital Federal 1108, ARGENTINA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| UNILEVER DE ARGENTINA SA | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | ARGENTINA | Calle Hipolito Bouchard 710 , Ciudad Autonoma Buenos Aires, Capital Federal ARGENTINA | 01/06/2011 | 53 D - - 02 Perfumes (Fragrance Preparations) | 53 D - - 99 Other Fragrance Preparations, N.E.C. | 62 W - - 99 Astringent/Anti-Perspirant N.E.C. | Rexona Antiperspirant | Rexona Antiperspirant | Rexona Antiperspirant | Argentina | Argentina | Argentina |
| Lebian International S R L | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | ARGENTINA | Calle La Paz 1071 , Rosario, Santa Fe ARGENTINA | 05/16/2014 | 85 H - - -- Portion of device code | Gynecological devices (Small #2; Medium #3; Large #4) | Autoexpandable and Discardable Speculum for Gynecological Use Models |
| Establecimiento El Jacaranda | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | ARGENTINA | Avenida Tte Gral Juan D Peron 630 , Chacabuco, Buenos Aires ARGENTINA | 07/09/2018 | 24 A - - 06 Garbanzo Bean | 24 E - - 06 Garbanzo Bean, Bean and Pea Sprouts | Garbanzo Bean (Chickpeas) | Garbanzo Bean (Chickpeas) | ATRAZINE; PERMETHRIN, TRANS; PIRIMIPHOS-METHYL; | ATRAZINE; PERMETHRIN, TRANS; PIRIMIPHOS-METHYL; |
| SURFOOD S.A | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | ARGENTINA | 4th Floor , Ciudad Autonoma Buenos Aires, Capital Federal ARGENTINA | 07/17/2017 | 24 B - - 09 Mung Bean, Dried or Paste | Green Mung Beans | PIRIMIPHOS-METHYL; |
| Alimentos Granix del la Assoc | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | unknown , Buenos Aires, ARGENTINA | 09/16/2009 | 03 F - - 99 Crackers (Non Filled) N.E.C. | Stoned wheat crackers | 3/25/94 | FENITROTHION; |
| BSP LARTI SA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Jose Ingenieros 3030 Dpto 10 - Beccar , Buenos Aires, ARGENTINA | 03/28/2025 | 24 A - - 09 Mung Bean | 24 B - - 09 Mung Bean, Dried or Paste | Mung beans | Mung beans | GLYPHOSATE; | GLYPHOSATE; |
| Conagra International | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Unknown Street , San Pedro, ARGENTINA | 09/16/2009 | 23 K - - 04 Sunflower Seed (Edible Seed) | Sunflower Seeds | FENITROTHION; | |
| COSTAEXPORT S.A.S. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Costa De Araujo , Ruta 34 S/N , Lavalle, Mendoza ARGENTINA | 04/16/2026 | 25 J - - 21 Garlic Bulb (Root & Tuber Vegetable) | Garlic | DELTAMETHRIN; |
| COSTAEXPORT SAS | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Calle 25 De Mayo 1327 Piso 0 , Mendoza, Mendoza ARGENTINA | 04/16/2026 | 25 J - - 21 Garlic Bulb (Root & Tuber Vegetable) | Garlic | DELTAMETHRIN; |
| Ecoholding S.R.L. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Av. Santa Fe 1127 Piso 10 Of Tcuit , Buenos Aires, ARGENTINA | 09/16/2009 | 20 Q - H 01 Apple, Dried or Paste, Ntrl/Artfcl Dried | 21 H - H 03 Cherry, Dried or Paste, Ntrl/Artfcl Dried | Dried Apples; 12/13/07 | Dried Cherries; 12/13/07 | PROPARGITE; | CARBOFURAN; |
| G N N Werthein SA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Calle Congreso 1685 , Ciudad Autonoma Buenos Aires, Buenos Aires ARGENTINA | 02/24/2020 | 20 N - - 01 Apple (Core Fruit) | 20 Q - - 01 Apple, Dried or Paste | Dried Apple Rings | Dried Apple Rings | IPRODIONE; | IPRODIONE; |
| J L SA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Presidente Illia S/N , Ticino, Cordoba ARGENTINA | 11/15/2021 | 23 B - - 07 Peanut, Shelled | Chopped Dry Roasted Peanuts | P-Chlorophenoxyacetic Acid (4-CPA) |
| Molinos Ala- Pilaga | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Ruta Provincial N.6 Km 48 - Franck , Santa Fe, AR-S ARGENTINA | 02/21/2020 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | 02 D - - 03 Rice, Enriched Processed (Packaged) | LONG GRAIN RICE ENRICHED PROCESSED | LONG GRAIN RICE ENRICHED PROCESSED | PIRIMIPHOS-METHYL; | PIRIMIPHOS-METHYL; |
| Montecoman S.A. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Charlone 2117 , Buenos Aires, ARGENTINA | 09/16/2009 | 20 N - H 03 Pear (Core Fruit), Ntrl/Artfcl Dried | 20 Q - - 03 Pear, Dried or Paste | Dried Pear; 3/3/04 | Dried Pear; 3/3/04 | CYPERMETHRIN; | CYPERMETHRIN; |
| NATURAL FOOD SRL | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Avenida Colon 140 Piso 4 , Cordoba, Cordoba ARGENTINA | 03/23/2026 | 24 A - - 16 Black Beans | 24 A - - 99 Beans, Corn, and Pea, N.E.C. (Vegetable) | 24 B - - 16 Black Bean, Dried or Paste | Black Beans | Black Beans | Black Beans | THIOPHANATE-METHYL; | THIOPHANATE-METHYL; | THIOPHANATE-METHYL; |
| Paladini Agroindustrias | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | 5411 Santa Lucia , San Juan, ARGENTINA | 09/16/2009 | 20 B - - 10 Raisins, Dried or Paste | Raisins | 1/3/2000 | BROMOPROPYLATE; |
| SURFOOD S.A | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | 4th Floor , Ciudad Autonoma Buenos Aires, Capital Federal ARGENTINA | 06/20/2019 | 24 A - - 09 Mung Bean | Mung Beans | HALOXYFOP; |
| TECNOCAMPO RIO PRIMERO | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Ruta 19 Km 283 , Rio Primero, AR-X ARGENTINA | 07/15/2019 | 24 A - - 06 Garbanzo Bean | 70 G - - 03 Chickpeas (Animal Food, Edible Seeds-Legumes) | Chickpeas (Garbanzo Bean) | Chickpeas (Garbanzo Bean) | Problem(s); GLUFOSINATE AMMONIUM | PIRIMIPHOS-METHYL; | Problem(s); GLUFOSINATE AMMONIUM | PIRIMIPHOS-METHYL; |
| Tecnocampo S.A. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Ruta Provincial 19 Km 316 , Monte Cristo, Cordoba ARGENTINA | 07/15/2019 | 24 A - - 06 Garbanzo Bean | 70 G - - 03 Chickpeas (Animal Food, Edible Seeds-Legumes) | Chickpeas (Garbanzo Bean) | Chickpeas (Garbanzo Bean) | Problem(s): GLUFOSINATE AMMONIUM | PIRIMIPHOS-METHYL; | Problem(s); GLUFOSINATE AMMONIUM | PIRIMIPHOS-METHYL; |
| Valley Evaporating Co. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARGENTINA | Ruta 151 Km.O Cipoletti R.N. , Cerrito 891 Piso 111 , Cipoletti Rio Negro, Buenos Aires ARGENTINA | 09/16/2009 | 20 N - - 01 Apple (Core Fruit) | Apple Chips | 11/14/2001 | PERMETHRIN, Total (cis-permethrin & trans-permethrin); |
| Agsof S.A. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ARGENTINA | Mitre 342 , Rosario De La Frontera, AR-A ARGENTINA | 12/08/2022 | 23 K - - 02 Sesame Seed (Edible Seed) | 28 A - - 43 Sesame, Whole (Spice) | Sesame Seed | Sesame Seed | Location listed is firm’s offices, Manufacturing Plant location: Agsof S.A. Ruta 34 km 1132 Guemes (4430) Salta Argentina Both locations are subject to DWPE under this listing. | Location listed is firm’s offices, Manufacturing Plant location: Agsof S.A. Ruta 34 km 1132 Guemes (4430) Salta Argentina Both locations are subject to DWPE under this listing. |
| Georgalos Hnos.S.A.I.C.A. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ARGENTINA | Blvd. Miguel Georgalos , Rio Segundo, Cordoba ARGENTINA | 11/18/2015 | 33 G - - 99 Soft Candy with Nuts or Nut Products, N.E.C. (without Chocolate) | 34 C - - 01 Chocolate Candy Bar, with Nuts or Nut Products (not Coconut) | Nucrem Peanut Candy Bar with Sunflower and Honey | Nucrem Peanut Candy Bar with Sunflower and Honey | |
| KEYMAR S.R.L | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ARGENTINA | Pedro Pico 849 , Buenos Aires, AR-B ARGENTINA | 04/21/2022 | 23 K - - 02 Sesame Seed (Edible Seed) | Sesame Seed | |
| Wishbone SRL | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | ARGENTINA | Calle Clotilde Donate 189 , Yerba Buena, Tucuman ARGENTINA | 12/16/2022 | 23 K - - 02 Sesame Seed (Edible Seed) | 23 R - - 02 Sesame Seed (Edible Seed Paste) | Sesame Seed | Sesame Seed | |
| BABIKIAN HEALTHCARE PRODUCTS | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | ARMENIA | 8 North Ave, Apt 22 , Yerevan, ARMENIA | 06/22/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) |
| Babikian Healthcare Products, CJSC | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | ARMENIA | Gevorg Chaush Hwy 90 , Proshyan Community, AM-KT ARMENIA | 06/22/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) | All Drug and Drug Products (including excipients) |
| ARSSI ALLIANCE LLC | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | ARMENIA | 24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA | 08/11/2023 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Aramax Victory Derma Liquid | Aramax Victory Immune Booster | Aramax Victory Derma Liquid | Aramax Victory Immune Booster | |
| Dr Ashely Minas | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | ARMENIA | 43 Moldovakan str. , Yerevan, Yerevan ARMENIA | 06/24/2015 | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | Interfall Hydrogel Products | Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com. |
| Dr. Ashley Minas | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | ARMENIA | No 31 Adranik Street , Meghri Town, Sunik ARMENIA | 06/24/2015 | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | Interfall Hydrogel Products | Class III. Interfall Hydrogel is a dermal filler marketed for; shaping the face; genitals; mammary glands and buttocks; elimination of deep deforming scars; and endoprosthetics of vocal cords in cases of paralytic stenosis of the larynx; as well as other purposes. Firm name could also be listed in records as Minasian Medical Centre and/or www.consultdrminas.com. |
| Rozfrud Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARMENIA | 1 Hakobyan 1 A , Vanadzor, Loru ARMENIA | 03/10/2022 | 21 H - - 13 Peach, Dried or Paste | Peach | PENCONAZOLE; Emamectin; |
| Sam Har LLC | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARMENIA | 2 Karmir Banakayinneri St , Abovian, Kotayki ARMENIA | 05/25/2011 | 24 U - - 69 Sorrel, Dried or Paste | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | Dry Sorrel | Dry Sorrel | CHLORPYRIFOS; | 650728-0 LOS-DO | CHLORPYRIFOS; |
| Sam-Har LLC | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | ARMENIA | 1/73 Kotayk Street , Abovyan, Kotayki ARMENIA | 08/14/2026 | 24 U - - 69 Sorrel, Dried or Paste | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | ||
| AND | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | ARMENIA | 7/20 Gayi Street , Sisian, Syuniki ARMENIA | 07/07/2026 | 36 C - - 02 Strained Honey | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | Organic Honey | Organic Honey | Organic Honey | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. |
| AND LLC | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | ARMENIA | 3/1 Village Ishkhanasar 13str , Sisian City Armenia, ARMENIA | 07/07/2026 | 36 C - - 02 Strained Honey | 36 C - - 04 Honey | 36 C - - 99 Honey, N.E.C. | Organic Honey | Organic Honey | Organic Honey | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. | The product is subject to refusal of admission pursuant to section 801(a)(3), in that it appears to be misbranded within the meaning of section 403(a)(1) of the Act in that the labeling is false or misleading; Section 403(i) of the Act for failing to bear the common or usual name of the food and the common or usual name of each ingredient; and Section 403(q) of the FD&C Act and 21 CFR 101.9, in that the nutrition information does not declare all required nutrients. |
| ARSSI ALLIANCE LLC | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | ARMENIA | 24 5.Ovanisyan Str. , Yerevan, Yerevan ARMENIA | 08/25/2023 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Immune Booster Antiviral | Immune Booster Antiviral | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. | he article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) because the label fails to declare the net quantity of contents, as required by 21 CFR 101.7. Section 403(i)(2) in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(q)(5)(F) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36 and 101.9. Section 403(s)(2)(B) because the label fails to identify the product using the term “dietary supplement” in accordance with 21 CFR 101.3(g). Section 403(s)(2)(C) because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. |
| MAG Meghvabucakan Enkerutyun | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | ARMENIA | 34 Zoravar Andranik, Zoravar Andranik 36 , Armavir, Aragatsotni Mars ARMENIA | 07/02/2026 | 36 C - - 04 Honey | AYGEE Multi-Flower Honey | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act. Labeling is false or misleading in any particular., the "Statement of Identity" must be the common or usual name of the food (21 CFR 101.3). In addition, the product is labeled as “Honey” and appears to also bear the claim “100% pure bee honey”. Section 403(i)(1) of the FD&C Act. Product is labeled as “Honey” and appears to bear the claim “100% pure bee honey”; however, FDA lab results support the presence of added C-4 sugars. Section 403(e)(1) of the FD&C Act. Label fails to bear the name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Label shows: “Imported by: Amexim Inc.” and a website; however, it does not appear to include the complete place of business. Online information cannot be used in lieu of the required address information, which must include the street address, city, State, and ZIP code in accordance with 21 CFR 101.5. Section 403(q) of the FD&C Act. Nutrition information does not declare added sugars and does not appear to declare Vitamin D and potassium, which are required nutrients under 21 CFR 101.9(c)(8). Labeling declares “Total Sugars 16 g” but does not declare added sugars. |
| Aruba Aloe Balm N.V. | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | ARUBA | Pitastraat 115 , Oranjestad, ARUBA | 04/15/2024 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Biomedical Holding AVV | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | ARUBA | Unknown , Unknown, ARUBA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | Pergonal and Metrodin | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 | 10/2/1992 |
| Clover Valley Meat Co. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | AUSTRALIA | 1111 Botany Rd , Mascot, New South Wales AUSTRALIA | 06/08/2012 | 16 M - - 13 Alligator & Crocodile, Other Aquatic Species | 17 Y - - 13 Bushmeat or Bush Meat or Wild Meats (Smoked, Roasted, Dried, Boiled, Broiled) | 17 Y - - 16 Reptiles, Whole or Meat, N.E.C. | Crocodile | Crocodile | Crocodile | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| AUSTRALIAN HIRAMASA PTY LTD | 16-125 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN WITH PROPER LABELING) RAW FISH AND FISHERY PRODUCTS IN REDUCED OXYGEN PACKAGING DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION" | AUSTRALIA | 130 Norrie Avenue , WHYALLA, AU-SA AUSTRALIA | 03/10/2010 | 16 A V - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Vacuum or Modified Atmosphere Packaging | Fresh Vacuum Packaged Tuna | Date removed - 3/10/2010 Method of control: Vitsab L5-8. |
| Job Fish Australia Pty Ltd | 16-125 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN WITH PROPER LABELING) RAW FISH AND FISHERY PRODUCTS IN REDUCED OXYGEN PACKAGING DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION" | AUSTRALIA | 60-64 Grice St , Clontarf, Queensland AUSTRALIA | 03/30/2011 | 16 A V - -- Fish, Vacuum or Modified Atmosphere Packaging | 16 X V - -- Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging | Fresh Vacuum Packed fish | Fresh Vacuum Packed fish | |
| BROW CODE PTY LTD | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | AUSTRALIA | 5 Distribution Ave , Molendinar, Queensland AUSTRALIA | 03/16/2022 | 50 N - - 18 Henna | 53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations) | 53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 14 Eyelash and Eyebrow Treatments-Gel, Oil, Primer, Conditioners, Serum, Fortifiers (Eye Makeup Prepara | 53 C - - 14 Eyelash and Eyebrow Treatments-Gel, Oil, Primer, Conditioners, Serum, Fortifiers (Eye Makeup Prepara | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 F - - 02 Hair Tints (Hair Coloring Preparations) | 53 F - - 02 Hair Tints (Hair Coloring Preparations) | Brow Code Indus Valley Henna Botanical Henna Powder | Brow Tint kit (Natural brown) | Brow Tint kit (Light brown) | Eyelash and Eyebrow Tint - GRAPHITE | Eyelash and Eyebrow Tint - LIGHT BROWN | Eyelash and Eyebrow Tint - NATURAL BROWN | Brow Code Indus Valley Henna Botanical Henna Powder | Brow Tint kit (Natural brown) | Brow Tint kit (Light brown) | Eyelash and Eyebrow Tint - NATURAL BROWN | Eyelash and Eyebrow Tint - GRAPHITE | Brow Code Indus Valley Henna Botanical Henna Powder | Brow Tint kit (Natural brown) | Eyelash and Eyebrow Tint - LIGHT BROWN | Brow Tint kit (Light brown) | Brow Tint kit (Natural brown) | Brow Tint kit (Light brown) | COAL TAR DYES | Problem(s): CI 77492 - IRON OXIDES BLACK 77491 & 77499 - IRON OXIDES - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted | 77491 & 77499 - IRON OXIDES; | Problem(s): CI 77491 - IRON OXIDES CI 77492 -IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) Note: CI 77491 - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted Label declares: "CI 77491, CI 77492." | Label declares: “CI 77491, CI 77499” – undeclared; Coal-tar dyes | Label declares: “CI 77499, CI 77491, CI 77492” – undeclared; Coal-tar dyes | Label declares: “CI 77499, CI 77491, CI 77492” – undeclared; Coal-tar dyes | COAL TAR DYES | Problem(s): CI 77492 - IRON OXIDES BLACK 77491 & 77499 - IRON OXIDES - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted | 77491 & 77499 - IRON OXIDES; | Problem(s): CI 77491 - IRON OXIDES CI 77492 -IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) Note: CI 77491 - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted Label declares: "CI 77491, CI 77492." | Label declares: “CI 77499, CI 77491, CI 77492” – undeclared; Coal-tar dyes | Label declares: “CI 77491, CI 77499” – undeclared; Coal-tar dyes | COAL TAR DYES | Problem(s): CI 77492 - IRON OXIDES BLACK 77491 & 77499 - IRON OXIDES - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted | 77491 & 77499 - IRON OXIDES; | Label declares: “CI 77499, CI 77491, CI 77492” – undeclared; Coal-tar dyes | Problem(s): CI 77491 - IRON OXIDES CI 77492 -IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) Note: CI 77491 - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted Label declares: "CI 77491, CI 77492." | Problem(s): CI 77492 - IRON OXIDES BLACK 77491 & 77499 - IRON OXIDES - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted | 77491 & 77499 - IRON OXIDES; | Problem(s): CI 77491 - IRON OXIDES CI 77492 -IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) Note: CI 77491 - IRON OXIDES – non-permitted CI 77492 - IRON OXIDES (SYNTHETIC FERROUS & FERRIC OXIDES) – non-permitted Label declares: "CI 77491, CI 77492." |
| Vani-T Pty Ltd | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | AUSTRALIA | SE 1 3 5 Kitawah St , Lonsdale, South Australia AUSTRALIA | 09/18/2009 | 53 M - - 01 Suntan Gels, Creams, Liquids (not Sunscreen) (Suntan Preparations) | 53 M - - 02 Indoor Tanning Preparations (Suntan Preparations) | 53 M - - 02 Indoor Tanning Preparations (Suntan Preparations) | 53 M - - 02 Indoor Tanning Preparations (Suntan Preparations) | 53 M - - 02 Indoor Tanning Preparations (Suntan Preparations) | liquid sun bronzing mist | Vani-T Dark Bronzing Glaze | liquid sun bronzing mist | Vani-T Dark Bronzing Glaze | liquid sun bronzing mist | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF) -non-permitted; 16185-AMARANTH (FORMER FD&C RED #2) -non-permitted; 16255-PONCEAU 4R (C.I. ACID RED 18) -non-permitted; 19140-FD&C YELLOW #5 (TARTRAZINE) -non-permitted; 20285-CHOCOLATE BROWN HT (C.I. FOOD BROWN 3) -non-permitted; 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF) -non-permitted; 5/28/08; mfr indicated on invoice | 16185-AMARANTH (FORMER FD&C RED #2); 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); 20285-CHOCOLATE BROWN HT (C.I. FOOD BROWN 3); 19140-FD&C YELLOW #5 (TARTRAZINE); 16255-PONCEAU 4R (C.I. ACID RED 18); | Undeclared | 14700-FD&C RED #4 (PONCEAU SX) {EXTERNAL ONLY}; 19140-FD&C YELLOW #5 (TARTRAZINE); | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF) -non-permitted; 16185-AMARANTH (FORMER FD&C RED #2) -non-permitted; 16255-PONCEAU 4R (C.I. ACID RED 18) -non-permitted; 19140-FD&C YELLOW #5 (TARTRAZINE) -non-permitted; 20285-CHOCOLATE BROWN HT (C.I. FOOD BROWN 3) -non-permitted; 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF) -non-permitted; 5/28/08; mfr indicated on invoice | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); 20285-CHOCOLATE BROWN HT (C.I. FOOD BROWN 3); 19140-FD&C YELLOW #5 (TARTRAZINE); 16255-PONCEAU 4R (C.I. ACID RED 18); | Undeclared | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF) -non-permitted; 16185-AMARANTH (FORMER FD&C RED #2) -non-permitted; 16255-PONCEAU 4R (C.I. ACID RED 18) -non-permitted; 19140-FD&C YELLOW #5 (TARTRAZINE) -non-permitted; 20285-CHOCOLATE BROWN HT (C.I. FOOD BROWN 3) -non-permitted; 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF) -non-permitted; 5/28/08; mfr indicated on invoice | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF); 16185-AMARANTH (FORMER FD&C RED #2); |
| Antaria Pty. Ltd. | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | Units 1 & 2 , 81 Shettleston Street , Rocklea, Queensland AUSTRALIA | 01/08/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Cosmetic Manufacturers (Aust) Pty Ltd. | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | U 3-14 Kingston Dr , Helensvale, Queensland AUSTRALIA | 01/08/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Delta Laboratories Pty Ltd | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | 8 Warringah Cl , Somersby, New South Wales AUSTRALIA | 09/28/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Antibiotics; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | All Drugs; Problem(s): (GMP) Good Manufacturing Practices | |
| Jalco Cosmetics Pty Ltd. | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | 45 King Rd , Hornsby, New South Wales AUSTRALIA | 03/08/2018 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Natural Beauty Care Pty Ltd | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | 8 Teton Court , Highett, Victoria AUSTRALIA | 03/23/2021 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Radpharm Scientific | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | 57 Oatley Court , Belconnen, AUSTRALIA | 09/10/2009 | 66 V I P 99 Miscellaneous Patent Medicines, Etc., Human - Investigational, Small Volume Parenteral <100ml | Nexavir | |
| Veganic SKN Limited | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | U 3 81 Shettleston Street , Rocklea, Queensland AUSTRALIA | 01/08/2026 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Wild Child Laboratories Pty Ltd. | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRALIA | 16 Howe St , Osborne Park, Western Australia AUSTRALIA | 10/28/2022 | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 M - - 99 Other Suntan Preparations (not Sunscreen), N.E.C. | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | For product codes 53L[][]08 and 53M[][]99; only products found to be drug products are subject to DWPE under this listing | For product codes 53L[][]08 and 53M[][]99; only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Alphapharm | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Chase Bldg 2wentworth Park Road , Glebe, NSW AUSTRALIA | 11/07/2011 | 61 B - - 02 Cyproterone Acetate (Anti-Androgen) | Cyproterone Acetate | Australia |
| AtheroCare | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 8-10 Cavill Avenue, Suite 574 165 , Surfers Paradise, Queensland AUSTRALIA | 03/17/2025 | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | AtheroCare Micro-Enema | AtheroCare Micro-Enema | |
| AUSTRALIAN HEALTH INDUSTRY CO. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 17 Birmingham Ave , Villawood, New South Wales AUSTRALIA | 09/29/2020 | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Eaoron Jacaranda Miracle Mask (for sensitive skin) | Eaoron Ageless Stem Cell Mask | Eaoron Jacaranda Miracle Mask (Ceramide) | Eaoron Hyaluronic Acid Collagen Essence V | Eaoron Instant Whitening Face Mask | Eaoron Jacaranda Miracle Mask (for sensitive skin) | Eaoron Instant Whitening Face Mask | Eaoron Jacaranda Miracle Mask (Ceramide) | Eaoron Ageless Stem Cell Mask | Eaoron Hyaluronic Acid Collagen Essence V | Eaoron Instant Whitening Face Mask | Eaoron Jacaranda Miracle Mask (for sensitive skin) | Eaoron Ageless Stem Cell Mask | Eaoron Jacaranda Miracle Mask (Ceramide) | Eaoron Hyaluronic Acid Collagen Essence V | Eaoron Jacaranda Miracle Mask (for sensitive skin) | Eaoron Ageless Stem Cell Mask | Eaoron Jacaranda Miracle Mask (Ceramide) | Eaoron Instant Whitening Face Mask | |
| BIO HEALTH PHARMACEUTICALS | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 12 Giffard St , SILVERWATER , Silverwater, New South Wales AUSTRALIA | 09/28/2012 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Sunchih Premium GPSP | Sunchih Bee Plus | Vita Cordy | Vita Cordy | Sunchih Bee Plus | Sunchih Premium GPSP | Sunchih Bee Plus | Sunchih Premium GPSP | Vita Cordy | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545. | NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545. | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545 | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545 | NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545. | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545 | NOTE: Bio Health Pharmaceuticals is a contract manufacturer for Concord International, FEI #3009408545. | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545. | NOTE; Bio Health Pharmaceuticals is a contract manufacturer for Concord International; FEI #3009408545 |
| Brands Rmj P L | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 490/500 Wellington Rd , Mulgrave, Victoria AUSTRALIA | 12/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 L - - 99 Thyromimetic N.E.C. | 66 - - - -- Human and Animal Drugs | Bowtech Lectric Soda Crystals | |
| Cat Media Pty Limited | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 18 Jubilee Ave , Warriewood, New South Wales AUSTRALIA | 04/03/2013 | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Photo Age Reverse Night Serum | Photo Age Reverse Cream | Photo Age Reverse Night Serum | Photo Age Reverse Cream | NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections | NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections. | NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections | NOTE; labels contain claims for reversing wrinkles; sunspots; and imperfections. |
| Cholrem Pty Ltd | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 20 Fairway Drive , CLEAR ISLAND WATERS , Gold Coast, Queensland AUSTRALIA | 03/17/2025 | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | RemChol Cavadex Enema | RemChol Cavadex Enema | |
| CONCORD INTERNATIONAL TRADING PTY LTD | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 12 Giffard St , Silverwater, New South Wales AUSTRALIA | 09/28/2012 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Sunchih Premium GPSP | Sunchih Bee Plus | Vita Cordy | Sunchih Premium GPSP | Vita Cordy | Sunchih Bee Plus | Sunchih Premium GPSP | Sunchih Bee Plus | Vita Cordy | |
| E-pharmacy.net | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | World Pharmacy Supplies , C/-suite 9; 14 Norton St , Leichhardt, New South Wales AUSTRALIA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| Homart Pharmaceuticals Pty. Ltd. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 59 Kirby St , Rydalmere, New South Wales AUSTRALIA | 07/26/2024 | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | SpringLeaf Propolis Liquid Alcohol Free 40% | SpringLeaf Propolis Liquid Alcohol Free 40% | |
| i-pharmacy | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | PO Box W66 , 14-16 Military Rd. , Watsons Bay, New South Wales AUSTRALIA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| Liberty Lifestyle Pty LTd. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Gpo Box 103 Concord West , Sydney, New South Wales AUSTRALIA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| Melcare Biomedical Pty | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 451 West Mount Cotton Rd , Mount Cotton, Qld AUSTRALIA | 03/24/2015 | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 K - - 99 Miscellaneous Antibiotics, N.E.C. | 60 - - - -- Human and Animal Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Optimel Manuka Dry Eye Drops | Optimel Manuka Forte Eye Gel | Optimel Manuka Forte Eye Gel | Optimel Manuka Dry Eye Drops | Optimel Antibacterial Manuka Eye Drops | Optimel Manuka Dry Eye Drops | Optimel Manuka Forte Eye Gel | Optimel Manuka Forte Eye Gel | Optimel Manuka Dry Eye Drops | Optimel Manuka Dry Eye Drops | Optimel Manuka Forte Eye Gel | Optimel Manuka Forte Eye Gel | Optimel Manuka Dry Eye Drops | Optimel Manuka Dry Eye Drops | Optimel Manuka Forte Eye Gel | Optimel Manuka Forte Eye Gel | Optimel Manuka Dry Eye Drops | Optimel Antibacterial Manuka Eye Drops | Optimel Manuka Forte Eye Gel | Optimel Manuka Dry Eye Drops | |
| Milk And Co Pty Ltd | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 15 Cotter St , Richmond, Victoria AUSTRALIA | 12/15/2015 | 53 A - - -- Baby Prod | 53 L - - -- Skin Care Prep | 53 M - - -- Suntan Preparations | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Spotty Tots Cream (rash & diaper cream) | Spotty Tots Cream (rash & diaper cream) | Spotty Tots Cream (rash & diaper cream) | Spotty Tots Cream (rash & diaper cream) | Product labeling makes claims | Product labeling makes claims | Product labeling makes claims | Product labeling makes claims |
| Natural Vitality | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 11 Aldinga St , Brendale, Queensland AUSTRALIA | 06/09/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Body Brilliance | Product label makes medical claims |
| Nutricia Australia | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Building D , L 4 12-24 Talavera Rd , Macquarie Park, New South Wales AUSTRALIA | 01/06/2016 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | SOUVENAID DIETARY SUPPLEMENTS | SOUVENAID DIETARY SUPPLEMENTS | Product labels made disease claims for Alzheimer?s disease | Product labels made disease claims for Alzheimer?s disease |
| Pro-Ma Systems (Aust.) Pty. Ltd. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 14 Kingston Dr , Helensvale, Queensland AUSTRALIA | 01/07/2014 | 53 G - - 03 Foundations (Makeup Preparations, not for Eyes) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 10 Wrinkle Smoothing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Aloe Oil Free Foundation | Infiniti Beauty Fluids | Platinum Reverse Wrinkle Serum | Intense Vita-Firm For Eyes | Country; Australia | Country; Australia | Country; Australia | Country; Australia |
| Sensuous | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 13 Knightsbridge Pde W , Paradise Point, Queensland AUSTRALIA | 10/01/2015 | 60 L - - 99 Analgesic, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Edge Delay Gel for Men | Edge Delay Gel for Men | |
| SUPERCHARGE FOOD PTY LTD | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 17 Brisbane St Bondi Junction , New South Wale, AUSTRALIA | 03/22/2021 | 02 G - - 99 Flours and Meals N.E.C. | 02 G - - 99 Flours and Meals N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Love Your Gut Micron 5 Diatomaceous Earth Capsules | Love Your Gut Diatomaceous Earth Powder | Fulvic Humic Concentrate | Fulvic Humic Concentrate | Love Your Gut Diatomaceous Earth Powder | Love Your Gut Micron 5 Diatomaceous Earth Capsules | Fulvic Humic Concentrate | Love Your Gut Diatomaceous Earth Powder | Love Your Gut Micron 5 Diatomaceous Earth Capsules | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Fulvic Humic Concentrate can be beneficial for people suffering from the symptoms of Leaky gut, IBS, Crohns [sic] disease, bloating, constipation, diarrhoea [sic] . . . small intestine bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD) . . . [A]nyone experiencing hangovers and people with heavy metal overload, adrenal fatigue issues and metabolic disorders.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Most people who ingest Diatomaceous Earth on a daily basis state they generally feel better because the bad bacteria, parasites and heavy metals are being removed from the body and so, the immune system has less work to do.' | The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'It's also anti-bacterial, anti-viral, anti-fungal and anti-parasitic.' |
| The Dispensary | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Nt Lusk , 25 Hipwood St , Norman Park, Queensland AUSTRALIA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| Ultra Mix (Aust) Pty Ltd | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 6 Mcarthur St , West Footscray, Victoria AUSTRALIA | 05/19/2016 | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | Outback Pain Relief Roll-On | Outback Pain Relief Roll-On | Outback Joint Care Nutritional Supplement | Outback Pain Relief Roll-On | Outback Joint Care Nutritional Supplement | Outback Pain Relief Roll-On | |
| Valu Pharmaceuticals.com | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Libery Lifestyle Pty Ltd , Barry West, Pob 103 Concord West , Sydney, Nsw 2138 AUSTRALIA | 09/30/2009 | 60 V - - 99 Anterior Pituitary Suppressor N.E.C. | 64 R - - 21 Somatropin (Hormone) | 64 X - - 11 Isotretinoin (Keratolytic) | Abarelix | |
| Wallace Service P/L Clive Wallace | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | 81 c Marine Pde , Seacliff, South Australia AUSTRALIA | 09/30/2009 | 65 P - - 02 Sildenafil Citrate (Regulator) | Web Site:Desc://www.levin-rx.com 5/27/2005 | |
| WallCann IP Pty Ltd | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRALIA | Drew Canning , 81c Marine Pde , Seacliff, South Australia AUSTRALIA | 09/30/2009 | 62 I - - -- A-Neoplastic | 64 X - - 06 Salicylic Acid (Keratolytic) | 64 X - - -- Keratolytic | 8/20/2007 Curaderm-BEC5 Cream 8/30/2007 | Curaderm-BEC5 Cream 8/30/2007 | Curaderm-BEC5 Cream 8/30/2007 | |
| Crowded Planet c/o Richard Hughes | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | AUSTRALIA | P.O. Box 920 , Wollongong (East), New South Wales AUSTRALIA | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 | All prescription drugs; 8/3/2001 |
| IDT Australia Ltd. | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | AUSTRALIA | 45 Wadhurst Dr , Boronia, Victoria AUSTRALIA | 09/30/2009 | 56 E - - 61 Minocycline Hydrochloride (Tetracyclines) | 11/2/2000 | |
| MEDIA NETWORKS SYDNEY PTY LIMITED | 66-79 | "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection" | AUSTRALIA | 36 Mid Dural Road , Galston, New South Wales AUSTRALIA | 07/09/2025 | 54 - D - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr | 54 - E - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr | 54 - F - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr | 54 - G - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr | 54 - I - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| PLANET LUXE OPERATIONS PTY LTD | 66-79 | "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection" | AUSTRALIA | 42 Barkly St , St Kilda, Victoria AUSTRALIA | 09/29/2023 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Biopharm Australia Pty. Ltd. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 111 Bronte Road , Bondi Junction, NSW AUSTRALIA | 03/31/2026 | 55 Y - - 99 Pharmaceutic Necessities and Containers, N.E.C. | 66 Q - - 10 Pentosan Polysulfate Sodium (Uricosuric) | Cartrophen Equine Forte | Cartrophen Equine Forte | |
| Ceva Animal Health Pty Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 11 Moores Rd , Glenorie, New South Wales AUSTRALIA | 09/09/2015 | 64 R J Y 99 Hormone N.E.C., Animal (Food Producing) - Non-Rx/Single Ingredient, NEC | REGULIN IMPLANT FOR EWES/50 DOSES | |
| Prestige Blending | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 59 Lahr's Rd , Ormeau, Queensland AUSTRALIA | 04/28/2021 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | 70 E - - 11 Amino Acid | Race Condition | Liquid Gold | Performance Horse Muscle Matrix | ProJoint | Race Condition | Performance Horse Muscle Matrix | Liquid Gold | ProJoint | ProJoint | Race Condition | Performance Horse Muscle Matrix | Liquid Gold | |
| Value Plus Animal Health Care Pr | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | 124 Toongabbie Rd , Girraween, New South Wales AUSTRALIA | 10/16/2023 | 60 Z - - 30 Praziquantel/Pyrantel Pamoate combination (Antiparasitic) | 62 L - - 47 Ivermectin (Anti-Protozoal, A-Leishmanial, Anti-Malarial) | Canine All Wormer | Valuheart | |
| Zoetis Australia Pty Ltd | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | AUSTRALIA | Level 6, 5 Rider Boulevard , Rhodes, AUSTRALIA | 12/12/2023 | 60 - R - -- Human and Animal Drugs, Animal (Non-Food Producing) Rx/Comb Ingredient | Simparica TRIO | Products subject to DWPE include those marketed for dogs weighing 2.6kg to 60kg. |
| Australian Light Therapy | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 108 Forrest Street , Cottesloe, WA AUSTRALIA | 09/16/2009 | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology | All devices. DE. Seasonal Affective Disorder Devices. (SAD Devices) | |
| Better Breathing Devices Pty Ltd | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | Suite A 13-17 Rivendell Drive , Tweed Heads South, New South Wales AUSTRALIA | 10/16/2023 | 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - WF Spirometer, Therapeutic (Incentive) | 73 B - - YI Percussor, Powered-Electric | 73 B - - YI Percussor, Powered-Electric | Better Breathing Sport | Better Breathing Kids | Better Breathing Sport | Better Breathing Kids | |
| Bionic Products Pty., Ltd. | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 63 Manly Drive , Robina, Queensland AUSTRALIA | 12/20/2018 | 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | Therapeutic Ionisers; Class III; 12/26/2002 | |
| Genetic Signatures Limited | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 7 Eliza St , Newtown, New South Wales AUSTRALIA | 01/21/2022 | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | EasyScreen SARS-CoV-2 Detection Kit (RP011 & RP011-HT) | |
| Medec Pty Ltd | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 22 Letchworth Centre Ave , Salter, FN AUSTRALIA | 09/16/2009 | 89 I - - SA Massager, Therapeutic, Electric | MEDEC BioResonance System | |
| MELBOURNE BIOTECH | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 5505 35 Queens Bridge Street , Southbank, Victoria AUSTRALIA | 10/20/2020 | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | MB COVID-19 Antibody Rapid Detection Test | |
| Planet Innovation Pty Ltd | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 436 Elgar Rd , Box Hill, Victoria AUSTRALIA | 08/31/2021 | 75 J - - JQ Colorimeter, Photometer, Spectrophotometer For Clinical Use | LIAISON IQ reader | |
| PROMEDICAL EQUIPMENT PTY LTD | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | AUSTRALIA | 5-22 Alexandra Pl , Murarrie, Queensland AUSTRALIA | 06/22/2020 | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | COVID-19 Rapid Test | COVID-19 Rapid Test | COVID-19 Rapid Test | |
| Lennonville Orchards | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | AUSTRALIA | 259 Lennon Rd , North Bruny, Tasmania AUSTRALIA | 06/11/2018 | 21 G - B 03 Cherry Fruit (Pit Fruit), Raw, Fresh, Ambient | 21 G - C 03 Cherry Fruit (Pit Fruit), Raw, Fresh, Refrigerated | Cherries | Cherries | 5/2/2005 | PIRIMICARB; | 5/2/2005 | PIRIMICARB; |
| Ag-Exports Pty Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | 282 Victoria Avenue , Chatswood, NSW AUSTRALIA | 09/16/2009 | 24 A - - 06 Garbanzo Bean | 24 B - - 09 Mung Bean, Dried or Paste | Chana Dall Dried Split Mung Beans | Chana Dall Dried Split Mung Beans | 10/4/1991 | CHLORPYRIFOS METHYL; | 10/4/1991 | CHLORPYRIFOS METHYL; |
| AGRIFOODS AUSTRALIA PTY TLD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | 46-48 Yumborra Rd , Dalby, Queensland AUSTRALIA | 06/04/2025 | 24 A - - 09 Mung Bean | 24 B - - 09 Mung Bean, Dried or Paste | 24 B - - 70 Lentils, Dried or Paste | 24 B - - 99 Bean, Corn, Pea, Dried or Paste, N.E.C. (Vegetable) | SWAD Moong Dal (Whole Mung beans) | SWAD Moong Dal (Whole Mung beans) | SWAD Moong Dal (Whole Mung beans) | SWAD Moong Dal (Whole Mung beans) | TEBUCONAZOLE; | TEBUCONAZOLE; | TEBUCONAZOLE; | TEBUCONAZOLE; |
| AUST-GRAIN EXPORTS PTY LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | Golf Course Road , Horsham, Victoria AUSTRALIA | 05/16/2019 | 24 A - - 09 Mung Bean | 24 B - - 99 Bean, Corn, Pea, Dried or Paste, N.E.C. (Vegetable) | Moong Whole (Mung Beans) | Moong Whole (Mung Beans) | GLYPHOSATE; HALOXYFOP; | GLYPHOSATE; HALOXYFOP; |
| Food Ingredients Australia Pty Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | SE 13 16-18 Malvern Ave , Chatswood, New South Wales AUSTRALIA | 09/16/2009 | 21 X - D 05 Mango (Subtropical/Tropical Fruit Pulp), Raw - Fresh, Frozen, Natural State | Mango juice concentrate | 3/13/01 | DIMETHOATE; |
| Henry Jones Foods Pty Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | Church Street Kyabram 3620 , P.O. Box 111 , Victoria, AUSTRALIA | 07/31/2018 | 21 H - - 01 Apricot, Dried or Paste | Apricot Paste | 12/7/1995 | CHLORPYRIFOS; |
| J K Int'L Pty Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | G.P.O. Box 1981 , Brisbane, Queensland AUSTRALIA | 09/25/2018 | 24 A - - 06 Garbanzo Bean | ||
| J K International Pty Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | Unknown , Queensland, AUSTRALIA | 09/16/2009 | 24 A - - 20 Chana Dal | 24 B - - 09 Mung Bean, Dried or Paste | Kala Chana Chick Peas | Chana Dall dried split mung beans | 8/4/1992 | CHLORPYRIFOS METHYL; | 10/4/1991 | CHLORPYRIFOS METHYL; |
| J.K International Pty. Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | 40 Suscatand Street, Rocklea, Qld. 4106 , Brisbane, AUSTRALIA | 09/16/2009 | 24 A - - 20 Chana Dal | split chick peas | 3/31/92 | CHLORPYRIFOS; |
| SOCIETA COFICA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | AUSTRALIA | 127 Chestnut St , Cremorne, Victoria AUSTRALIA | 01/27/2020 | 24 A - - 70 Lentils | 24 A - - 99 Beans, Corn, and Pea, N.E.C. (Vegetable) | 24 B - - 70 Lentils, Dried or Paste | Red Whole Lentils | Red Whole Lentils | Red Whole Lentils | HALOXYFOP; | HALOXYFOP; | HALOXYFOP; |
| B & G Export Corporation Pty Ltd | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 123 Clarence St , Sydney, New South Wales AUSTRALIA | 09/16/2009 | 17 A - - 19 Kangaroo | Frozen Kangaroo Meat | 2/1/06 | SALMONELLA; |
| Clover Valley Meat Co. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 1111 Botany Rd , Mascot, New South Wales AUSTRALIA | 09/16/2009 | 17 A - - 19 Kangaroo | 8/9/07 | SALMONELLA; | |
| D'Groot International Food Marketin | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 82 Penzance Dr , Redland Bay, Queensland AUSTRALIA | 10/20/2009 | 17 A - - 19 Kangaroo | Kangaroo Meat | SALMONELLA; |
| Intercontinental Grain Exports | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 52 Struen Marie Kareel , Newport, FN AUSTRALIA | 09/16/2009 | 02 A - - 99 Grain, Whole, N.E.C. | 24 A - - 18 Alfalfa beans (seeds) | 24 E - - 18 Alfalfa beans (seeds), Bean and Pea Sprouts | Alfalfa seeds | alfalfa seeds | Alfalfa Seeds | 6/12/01 | SALMONELLA; | 6/12/01 | SALMONELLA; |
| Lenah Game Meats | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 315 Georgetown Rd , Rocherlea, TAS AUSTRALIA | 09/16/2009 | 17 A - - 22 Opossum | frozen possum meat | 2/26/02 | SALMONELLA; |
| Meramist Pty. Ltd. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | Old Gympie Road , PO Box 285 , Caboolture, Queensland AUSTRALIA | 09/16/2009 | 17 A - - 15 Camel | 17 A - - 99 Red Meat Products, N.E.C. | boneless camel meat trimmings | boneless camel meat trimmings | 6/20/02 | SALMONELLA; | 6/20/02 | SALMONELLA; |
| Naturally Australian Meat & Game | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | Kalypso Kold Store , L 1 363 Lytton Rd , Morningside, Queensland AUSTRALIA | 08/30/2013 | 17 A - - 19 Kangaroo | Kangaroo Meat | SALMONELLA; |
| Southern Game Meat Pty Ltd | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | AUSTRALIA | 22 Churchill St , Silverwater, New South Wales AUSTRALIA | 09/16/2009 | 17 A - - 19 Kangaroo | frozen kangaroo meat | 5/24/1999 |
| Homart Pharmaceuticals Pty. Ltd. | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRALIA | 59 Kirby St , Rydalmere, New South Wales AUSTRALIA | 07/31/2024 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Aussie Kids Gummy Lutein (Berry Shaped NO Added Sugar) | Kids Genius Fish Oil | Propolis Liquid (alcohol free) 40% | SpringLeaf brand Inner Beauty Collagen 6 In 1 | Aussie Kids Gummy Lutein (NO Added Sugar) | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (Berry Shaped, NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Kids Genius Fish Oil dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(b) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Propolis Liquid (alcohol free) 40% (outer and inner container labels) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Inner Beauty Collagen 6 in 1 dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a), (b), and (g)]. Section 403(q) of the Act. presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. The Aussie Kids Gummy Lutein (NO Added Sugar) dietary supplement products incorrectly display nutrition labeling under the heading of “Nutrition Information” for a serving of a dietary supplement product. The nutrition information should be presented using the formatting of a Supplement Facts label and include the Daily Values for (b)(2)-dietary ingredients if present in amounts greater than amounts that can be declared as 0, in according with 21 CFR 101.36(b). Section 403(i)(2) of the Act. The label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(y) of the Act. The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1], may receive a report of a serious adverse event with such dietary supplements. |
| Natural Vitality | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRALIA | 11 Aldinga St , Brendale, Queensland AUSTRALIA | 06/09/2017 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Body Brilliance | Male Testo Dietary Supplement | The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. | The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. The articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. |
| Steric Trading Pty Ltd | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRALIA | 33-61 Malta Street , Fairfield East, New South Wales AUSTRALIA | 07/09/2025 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Hydration Inner Beauty Boost Dietary Supplement | Glow Ageless Inner Beauty Essential Dietary Supplement | Glow Ageless Inner Beauty Essential Dietary Supplement | Hydration Inner Beauty Boost Dietary Supplement | Hydration Inner Beauty Boost Dietary Supplement | Glow Ageless Inner Beauty Essential Dietary Supplement | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. | The products are subject to refusal of admission pursuant to section 801(a)(3), in that they appear to be misbranded within the meaning of section 403(y) of the FD&C Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. This is based on an establishment inspection of this firm conducted by FDA. |
| Andora-Cosmetic | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | AUSTRIA | Unknown Street , Vienna, AUSTRIA | 08/16/2022 | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | Andora -Augenbrauen und Wimpernfarbe all shades | Coal tar dyes | COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES); |
| GW Cosmetics GmbH | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | AUSTRIA | Achauerstrasse 49a 2333 , Leopoldsdorf, Niederoesterreich AUSTRIA | 03/02/2020 | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 14 Eyelash and Eyebrow Treatments-Gel, Oil, Primer, Conditioners, Serum, Fortifiers (Eye Makeup Prepara | 53 C - - 99 Other Eye Makeup Preparations, N.E.C. | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | RefectoCil Eyelash Lift Kit | Eyelash Curl and Lift Perm and Neutralizer Refill | Refecto Cil - Augenbrauen und Wimperfarbe graphite; black; brown and blue-black shades | RefectoCil Sensitive Developer Gel | EWC Groom Step 1; Semi-Permanent Eyebrow Colorant Gel (Eyebrow Tint) | RefectoCil Sensitive Medium Brown Eyelash and Eyebrow Tint | RefectoCil Sensitive Dark Brown Eyelash and Eyebrow Tint | EWC Groom Step 1; Semi-Permanent Eyebrow Colorant Gel (Eyebrow Tint) | EWC Groom Step 1; Semi-Permanent Eyebrow Colorant Gel (Eyebrow Tint) | EWC Groom Step 1; Semi-Permanent Eyebrow Colorant Gel (Eyebrow Tint) | 47005-D&C YELLOW #10 (QUINOLINE YELLOW WS DI, NA DISULFONATE) -non permitted | 47005-D&C YELLOW #10 (QUINOLINE YELLOW WS DI, NA DISULFONATE); | 47005-D&C YELLOW #10 (QUINOLINE YELLOW WS DI, NA DISULFONATE) -non permitted | 47005-D&C YELLOW #10 (QUINOLINE YELLOW WS DI, NA DISULFONATE); | Coal tar dyes | COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES); | UNIDENTIFIED COLOR (ENTER NAME IN REMARKS); Silver Nitrate -non permitted | SAFFLOWER FLOWER - 2013 non-permitted GOLDENROD - 2013 non-permitted ACACIA CATECHU WOOD - 2013 non-permitted | Problem(s): UNIDENTIFIED COLOR (ENTER NAME IN REMARKS); Walnut Husk and Horse Chestnut- non permitted | Problem(s): UNIDENTIFIED COLOR (ENTER NAME IN REMARKS); Walnut Husk and Horse Chestnut- non permitted | SAFFLOWER FLOWER - non-permitted GOLDENROD - non-permitted ACACIA CATECHU WOOD - non-permitted | SAFFLOWER FLOWER - non-permitted GOLDENROD - non-permitted ACACIA CATECHU WOOD - non-permitted | SAFFLOWER FLOWER - non-permitted GOLDENROD - non-permitted ACACIA CATECHU WOOD - non-permitted |
| W. Pauli | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | AUSTRIA | A-1160 , Vienna, AUSTRIA | 08/16/2022 | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | Dr Olbrich's Combinal Augenbrauen und Wimperfarbe black; brown; blue; grey shades | Pialan Hair Dye | Mfr.; coal tar dyes | COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES); | Mfr.; coal tar dyes 10/22/1992 | COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES); |
| Schrofner Cosmetics Gmbh | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | AUSTRIA | Robinigstrase 26a , Salzburg, Salzburg AUSTRIA | 10/20/2017 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | All Drugs;Problem(s): (GMP) Good Manufacturing Practices | |
| Nowicky Pharma | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRIA | Margaretenstrase 7/A-1040 , Vienna, Wien AUSTRIA | 03/16/2022 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | Ukrain UKRAIN is an injectable promoted as an anticancer drug. This product should be refused unless it is coming in under 21 CFR 312.160 or has an IND in effect. 2/6/2004 | |
| SKYLINE HANDELS GMBH | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AUSTRIA | Mariahilfer Strase 72 , Vienna, Vienna AUSTRIA | 08/01/2019 | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 53 - - - -- Cosmetics | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Jungle Juice (all variations - e.g. ultra strong super premium etc.) | Locker Room (all label color variations) | Iron Horse (all variations - e.g. ultra strong super premium etc.) | Rush Ultra Strong (all label color variations) | The New Amsterdam (all variations - e.g. ultra strong super premium etc.) | Super Rush Liquid Incense (all label color variations) | Gold Rush Leather Cleaner | Fist F*ck (all variations - e.g. ultra strong super premium etc.) | Rush (all variations - e.g. ultra strong super premium etc.) | Iron Horse (all variations - e.g. ultra strong super premium etc.) | Super Rush Liquid Incense (all label color variations) | Rush (all variations - e.g. ultra strong super premium etc.) | Gold Rush Leather Cleaner | Locker Room (all label color variations) | Jungle Juice (all variations - e.g. ultra strong super premium etc.) | The New Amsterdam (all variations - e.g. ultra strong super premium etc.) | Rush Ultra Strong (all label color variations) | Fist F*ck (all variations - e.g. ultra strong super premium etc.) | Rush Ultra Strong (all label color variations) | Locker Room (all label color variations) | Gold Rush Leather Cleaner | Iron Horse (all variations - e.g. ultra strong super premium etc.) | Rush (all variations - e.g. ultra strong super premium etc.) | Super Rush Liquid Incense (all label color variations) | Jungle Juice (all variations - e.g. ultra strong super premium etc.) | Fist F*ck (all variations - e.g. ultra strong super premium etc.) | The New Amsterdam (all variations - e.g. ultra strong super premium etc.) | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list); '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them; creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles; such as the throat and anus. Not only do they enhance sexual pleasure; they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. | The product appears to be an unapproved new drug as the products' promotional website includes structure/function claims such as (not an all-inclusive list): '...What are poppers? Poppers are mostly sold as room aromas or leather cleaners and may act as vasodilators when breathed as most people ... use it for recreational purposes by inhaling them, creating a head rush and enabling enhanced sensations during sex as well as relaxing your muscles, such as the throat and anus. Not only do they enhance sexual pleasure, they produce a sensation of heat and excitement for a couple of minutes...'. |
| Sandoz GmbH | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | AUSTRIA | Biochemiestrase 10 , Kundl, Tirol AUSTRIA | 09/30/2009 | 56 D - - 31 Kanamycin Sulfate (Aminoglycosides) | 56 K - - 70 Rifampin | 11/2/2000 | 11/2/2000 | |
| APO Fruchtsaefte GmbH | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRIA | Gossering 1 , Millstatt, Karnten AUSTRIA | 10/02/2015 | 29 B - T 99 Carbonated Soft Drink, N.E.C., Packaged Food (Not Commercially Sterile) | MitoChon Energy Drink | ***Charges: 403(i)(2), 403(q)(5)(F), 403(y). The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of Federal Food, Drug and Cosmetic Act (the Act) in that it is fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36. Specifically: In the "other" section of the product's ingredient list, the product lists "Trade Secret Stabilization Process" and "Solubilized in water from the Austrian Alps." While these may be true statements, the former is not appropriate to list in the ingredients section of the product and the latter is not the common or usual name for "water." Additionally, ingredients such as NADH, Q10H2, Pyridoxal- 5'-PO43, and Vitamin B2 RSP must be spelled out or listed by their common and usual names. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act in that your "Supplement Facts" panel is not in an appropriate format as required by 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (y) [21 U.S.C. § 343(y)] of the Act. The label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 [21 U.S.C. § 379aa-1] of the Act, may receive a report of a serious adverse event with such dietary supplement. *** |
| Rey GmbH | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRIA | Hauptstrase 33 , St.Michael i.Obersteiermark, Steiermark AUSTRIA | 10/02/2015 | 29 B - T 99 Carbonated Soft Drink, N.E.C., Packaged Food (Not Commercially Sterile) | MitoChon Energy Drink | *** Charges: 403(i)(2), 403(q)(5)(F), 403(y). The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of Federal Food, Drug and Cosmetic Act (the Act) in that it is fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36. Specifically: In the "other" section of the product's ingredient list, the product lists "Trade Secret Stabilization Process" and "Solubilized in water from the Austrian Alps." While these may be true statements, the former is not appropriate to list in the ingredients section of the product and the latter is not the common or usual name for "water." Additionally, ingredients such as NADH, Q10H2, Pyridoxal- 5'-PO43, and Vitamin B2 RSP must be spelled out or listed by their common and usual names. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act in that your "Supplement Facts" panel is not in an appropriate format as required by 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (y) [21 U.S.C. § 343(y)] of the Act. The label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 [21 U.S.C. § 379aa-1] of the Act, may receive a report of a serious adverse event with such dietary supplement.*** |
| WOMEN'S BEST | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | AUSTRIA | Eduard-Bodem-Gasse 3 , Innsbruck, Tirol AUSTRIA | 12/13/2018 | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Protein Wafers Chocolate (conv food) | Slim Body Shake All-in-One Meal Replacement Blend (conv food) | Protein Creme (conv food) | Fit Pro Whey 100% Premium Whey Protein; 3 flavors (conv food) | BCAA Amino (2 flavors) (dietary supplement) | Pre Workout Booster (2 flavors) (dietary supplement) | True Beauty Collagen Drink for Skin;Nails & Hair (Dietary Supplement) | Joint Support (dietary supplement) | Amino & Energy Essential Amino Acid and Energy Support (dietary supplement) | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ; | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ; | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard ; | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard | Problem(s) Misbranded; The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(g)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided by section 401 of the FD&C Act and the article does not conform to such definition and standard. ; |
| AZSAFFRON MMC | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AZERBAIJAN | Nizami 93 , Baku City, AZERBAIJAN | 04/14/2026 | 28 A - - 40 Saffron, Whole (Spice) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Saffron | Saffron | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Saffron is used in the treatment of various diseases such as functional disorders of the heart, cancer, inflammation of the kidneys and liver, seizures, gastrointestinal diseases. Since ancient times saffron has been used as a strong bacteri-cidal . . . Saffron also has a positive effect against the herpes virus.” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Saffron is used in the treatment of various diseases such as functional disorders of the heart, cancer, inflammation of the kidneys and liver, seizures, gastrointestinal diseases. Since ancient times saffron has been used as a strong bacteri-cidal . . . Saffron also has a positive effect against the herpes virus.” |
| AZZEFERAN-AZSAFFRON MMC | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | AZERBAIJAN | Ilgar Mirzayev Str. 11d , Baku, Baki AZERBAIJAN | 04/14/2026 | 28 A - - 40 Saffron, Whole (Spice) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Saffron | Saffron | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Saffron is used in the treatment of various diseases such as functional disorders of the heart, cancer, inflammation of the kidneys and liver, seizures, gastrointestinal diseases. Since ancient times saffron has been used as a strong bacteri-cidal . . . Saffron also has a positive effect against the herpes virus.” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Saffron is used in the treatment of various diseases such as functional disorders of the heart, cancer, inflammation of the kidneys and liver, seizures, gastrointestinal diseases. Since ancient times saffron has been used as a strong bacteri-cidal . . . Saffron also has a positive effect against the herpes virus.” |
| Blue Fisheries Ltd. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BAHAMAS | Morgans Bluff , Andros, BAHAMAS | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | DWPE date - 9/28/1993 | DWPE date - 9/28/1993 | DWPE date - 9/28/1993 | |
| Coral Pharmaceuticals LTD | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | BAHAMAS | Logwood Rd 20 , Freeport, City of Freeport BAHAMAS | 09/25/2019 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Howard Medical International | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | BAHAMAS | Trinity Place Annex , Nassau, BAHAMAS | 01/25/2021 | 86 L - - ZP Aid, Surgical, Viscoelastic | Perfluorodecaline for vet use | |
| ASAP Service Limited | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BAHAMAS | P.O. Box N-1836 , Suite A 003 , Nassau, BAHAMAS | 06/27/2018 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | Skin Cap Spray, Shampoo and Cream; Problem(s): Product is an OTC product containing a prescription strength corticosteroid (clobetasol propionate). | |
| Lenex Labs | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BAHAMAS | Wavecrest House West Bay St , P O Box N-8174 , Nassau, BAHAMAS | 09/30/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All products. Boston district received promotional material and mail order solicitation for drugs from Alpha Omega Labs. The material accompanied a letter from Lenex Labs in which Lenex stated that Alphas Omega would service orders on Lenex's former products. The firm offers a variety of products, including cancer inhibitors, weight loss products, and treatment for toxic bowel syndrome. | |
| NEW LIFE NATURAL VEGETATION CELL | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BAHAMAS | Lucaya Shopping Cent 14 , Freeport City, BAHAMAS | 08/25/2017 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 56 G - - 99 Antifungal N.E.C. | 60 N - - 14 Testosterone (Androgen) | 62 C - - 99 Anti-Hypertensive N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 V - - 99 Anti-Viral N.E.C. | 64 B - - 99 Diuretic N.E.C. | 64 N - - 07 Iron Dextran (Inj) (Hematinic) | 66 S - - 40 Inositol Niacinate (Vasodilator) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Bilberry Raspberry Tonic | Sea Moss Bladderwrack Mix | Nerve Tonic | Cat Island Restoration Tonic | Male ThunderStrike | Special Healing Tonic | Iron Plus Formula | Draco Tonic | Male ThunderStrike | Nerve Tonic | Special Healing Tonic | Cat Island Restoration Tonic | Sea Moss Bladderwrack Mix | Iron Plus Formula | Chelation | Iron Plus Formula | Draco Tonic | Special Healing Tonic | Cat Island Restoration Tonic | Sea Moss Bladderwrack Mix | Male ThunderStrike | Bilberry Raspberry Tonic | Chelation | Nerve Tonic | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website | Drug claims made on product labeling and product website |
| Planet Systems, Inc. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BAHAMAS | John Variss , 58 Shirley St.,1st Floor PO Box 88 15670 , Nassau, BAHAMAS | 09/30/2009 | 64 X - - 11 Isotretinoin (Keratolytic) | 2/8/2007 | |
| DurusPharma | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Peel Street 4 , Grand Bahamas , Freeport, City of Freeport BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 |
| InterPharm Inc (d/b/a International Pharmacy) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Po Box N-3036 , Nassau, New Providence BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | |
| Juan Martinez Minitraders | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P.O. Box N-121 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | All prescription drugs; 2/19/02 | |
| Medicine Club of America Inc (International Pharmacy) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P O Box N-3036 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | All prescription drugs 10/21/1992 | |
| Minitraders (Mr. Juan Martinez) | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P.O. Box N-121 , Nassau , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). | All prescription drugs - 3/14/2000 The following firms/products were noted on their Internet web sites offering for sale drugs which appear to be prescription drugs in the United States (U.S.). FDA is unable to determine if the drugs marketed by these firms have been made in accordance with the U.S. specifications and are the same product marketed legally in the United States. Therefore, the sale and distribution of these products on their Internet web site may be illegal in this country (U.S.) and may be in violation of Title 21 of the United States Code, Section 331(a), 331(d) and 355(a). |
| Northam Medication Service | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | P O Box N-7108 , Nassau, BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | All prescription drugs | |
| Universal Trading | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BAHAMAS | Harbour Building , Suite 6-1; Grand Bahama Island , Freeport, City of Freeport BAHAMAS | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 | All prescription drugs; 4/4/2003 |
| Allied Signal | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | BAHAMAS | W Sunrise Hwy , Freeport, City of Freeport BAHAMAS | 09/30/2009 | 62 G - S 49 Naproxen (Anti-Inflammatory), Active Pharm Ingred/Chems for Further Manuf | Naproxen | 11/2/2000 |
| Pharmaceutical Fine Chemicals Ltd | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | BAHAMAS | Po Box F-2430 , Freeport, City of Freeport BAHAMAS | 09/30/2009 | 62 O - S 27 Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf | Doxazosin Mesylate | 11/2/2000 |
| IHT Ltd | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BAHAMAS | P.O. Box N4361 , Nassau, BAHAMAS | 09/16/2009 | 82 - - - -- Immunology | HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. Note HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827- 6201. | |
| Newco Associates Limited | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BAHAMAS | P.O. Box CB12611 , Nassau, BAHAMAS | 09/16/2009 | 82 - - - -- Immunology | HIV Oral Test (aka 1; 2 and Subtype O Saliva Test). 10/26/1999. HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. | |
| NEW LIFE NATURAL VEGETATION CELL | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BAHAMAS | Lucaya Shopping Cent 14 , Freeport City, BAHAMAS | 09/05/2017 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 56 G - - 99 Antifungal N.E.C. | 60 N - - 14 Testosterone (Androgen) | 62 C - - 99 Anti-Hypertensive N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 62 V - - 99 Anti-Viral N.E.C. | 64 B - - 99 Diuretic N.E.C. | 64 N - - 07 Iron Dextran (Inj) (Hematinic) | 66 S - - 40 Inositol Niacinate (Vasodilator) | Nerve Tonic | Bilberry Raspberry Tonic | Iron Plus Formula | Special Healing Tonic | Male ThunderStrike | Cat Island Restoration Tonic | Sea Moss Bladderwrack Mix | Draco Tonic | Male ThunderStrike | Nerve Tonic | Special Healing Tonic | Cat Island Restoration Tonic | Sea Moss Bladderwrack Mix | Iron Plus Formula | Chelation | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(2) of the Act [21 U.S.C. ? 343(i)(2)] in that it purports to be a beverage containing fruit but the label does not bear a declaration of the total percentage of juice in accordance with 21 CFR 101.30. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (3) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (4) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (5) Section 403(r)(1)(A) of the Act [21 U.S.C. ? 343(r)(1)(A)] because the label bears the claim ?iron plus? but does not meet the requirements in 21 CFR 101.54(e) to bear that claim. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the product fails to provide any nutrition information as required by 21 CFR 101.36 and does not appear to meet the exemption criteria provided in 21 CFR 101.36(h). (4) Section 403(i)(1) of the Act [21 U.S.C.(i)(1)] in that the ?dietary supplement? statement of identity is not in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d). (5) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis | The product appears to be misbranded within the meaning of; (1) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (4) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3. | The product appears to be misbranded within the meaning of; (1) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (2) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (3) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(q)(5)(F) of the Act [21 U.S.C. ? 343(q)(5)(F)] in that the product fails to provide any nutrition information as required by 21 CFR 101.36 and does not appear to meet the exemption criteria provided in 21 CFR 101.36(h). (4) Section 403(i)(1) of the Act [21 U.S.C.(i)(1)] in that the ?dietary supplement? statement of identity is not in a size reasonably related to the most prominent printed matter on the principal display panel as required by 21 CFR 101.3(d). (5) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis | The product appears to be misbranded within the meaning of; (1) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(q) of the Act [21 U.S.C. 343 (q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. (3) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (4) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (5) Section 403(r)(1)(A) of the Act [21 U.S.C. ? 343(r)(1)(A)] because the label bears the claim ?iron plus? but does not meet the requirements in 21 CFR 101.54(e) to bear that claim. | The product appears to be misbranded within the meaning of; (1) Section 403(i)(2) of the Act in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. (2) Section 403(e)(1) of the Act [21 U.S.C. ? 343 (e)(1)] in that they fail to list the place of business of the manufacturer; packer; or distributor in accordance with 21 CFR 101.5. (3) Section 403(e)(2) of the Act [21 U.S.C. ? 343(e)(2)] because the labels fail to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.? 1453(a)(2) of the Fair Packaging and Labeling Act. A statement of fluid measure must be followed by the metric equivalent in parenthesis. (4) Section 403(i)(1) of the Act [21 U.S.C. ? 343(i)(1)] in that the labels fail to bear appropriate statements of identity in accordance with 21 CFR 101.3. |
| Purity Bakery | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BAHAMAS | Market Street , Nassau And Paradise Island, New Providence BAHAMAS | 11/19/2015 | 03 R - - 01 Cake Without Custard or Cream Filling | 03 R - - 01 Cake Without Custard or Cream Filling | 03 R - - 01 Cake Without Custard or Cream Filling | Bacardi Rum Cake | Chocolate Rum Cake | Pina Colada Rum Cake | "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Bacardi Rum Cake," products are misbranded within meaning of section 403 (i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. "Bacardi Rum Cake" product labels declare "vegetable oil" as an ingredient; however, you fail to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b) (14)). "Bacardi Rum Cake" product labels declare "enriched flour" which is a standardized food under 21 CFR 137.165. However, you fail to list the sub- ingredients on your finished product labels. "Bacardi Rum Cake" products are manufactured using "water;" however, you fail to list this ingredient on your finished product label. "Bacardi Rum Cake" product label declares "walnuts;" however, this is not an ingredient in your product formulation. "Bacardi Rum Cake" products are manufactured using "pudding cake base;" however, you fail to list all the sub-ingredients on your finished product labels. "Bacardi Rum Cake," products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105. | "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Chocolate Rum Cake," products are misbranded within meaning of section 403(i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example: "Chocolate Rum Cake" product label fails to include an ingredient statement. "Chocolate Rum Cake," products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105 | "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2), 403(e)(1), and 403(e)(2), of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically: "Pina Colada Rum Cake" products are misbranded within meaning of section 403(i)(2) of the Act in that they are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example: "Pina Colada Rum Cake" product labels declare "vegetable oil" as an ingredient; however, you fail to list each individual fat and/or oil ingredient as required by 21 CFR 101.4(b) (14)). "Pina Colada Rum Cake" product labels declare "enriched flour" which is a standardized food under 21 CFR 137.165. However, you fail to list the sub-ingredients on your finished product labels. "Pina Colada Rum Cake" products are manufactured using "water;" however, you fail to list this ingredient on your finished product label. "Pina Colada Rum Cake" products are manufactured using "pudding cake base;" however, you fail to list all the sub-ingredients on your finished product labels. "Pina Colada Rum Cake" product are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that the label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. "Pina Colada Rum Cake" products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels fail to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.105. |
| MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 | 16-04 | Detention Without Physical Examination of Seafood Products That Appear To Be Misbranded | BANGLADESH | Bfdc Plot # 22, Block # B , Ichanagar, Karnafuly , Chattagram, BANGLADESH | 08/09/2017 | 16 A - - 09 Carp | 16 A - - 13 Croaker | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 62 Snake Head | 16 A - - 83 Goby | 16 A - - 84 Threadfin | 16 A - - 85 Barramundi | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Large Razor Belly Minnow (Salmostoma bacaila) | POA; Pama croaker; Otolithoides pama | Ganges River Sprat (Corica soborna) | TAKI; Spotted snakehead; Channa punctata | BAILA GURA; tank goby; Glossogobius giuris | Fourfinger Threadfin (Eleutheronema tetradactylum) | DESHI KORAL; barramundi or Asian sea bass; Lates calcarifer | MENI; Gangetic leaffish; Nandus nandus | Fourfinger Threadfin (Eleutheronema tetradactylum) | TAKI; Spotted snakehead; Channa punctata | Bombay Duck (Harpadon nehereus) | Ganges River Sprat (Corica soborna) | Anchovy /Ramcarat Grenadier Anchovy (Coilia ramcarati) | Large Razor Belly Minnow (Salmostoma bacaila) | DESHI KORAL; barramundi or Asian sea bass; Lates calcarifer | POA; Pama croaker; Otolithoides pama | Sardine/White Sardine (Escualosa thoracata) | Whiting/Sillago/Flat Head Sillago (Sillago domina) | Rohu (Labeo rohita) | Croaker/Pama Croaker (Otolithoides pama) | Calbasu (Labeo calbasu) | BAILA GURA; tank goby; Glossogobius giuris | FOLI; bronze featherback; Notopterus notopterus | Olive Barb (Puntius sarana) | Large Razor Belly Minnow misdeclared as Chalapata | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Ganges River Sprat misdeclared as Keski | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Fourfinger Threadfin misdeclared as Tailla | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Fourfinger Threadfin misdeclared as Tailla | Problem(s);The label fails to bear the common or usual name of the food; if any there be. | Bombay Duck misdeclared as Lotia | Ganges River Sprat misdeclared as Keski | Anchovy /Ramcarat Grenadier Anchovy misdeclared as Olwa | Large Razor Belly Minnow misdeclared as Chalapata | Problem(s);The label fails to bear the common or usual name of the food; if any there be. | Problem(s);The label fails to bear the common or usual name of the food; if any there be. | Sardine/White Sardine misdeclared as Mola | Whiting/Sillago/Flat Head Sillago misdeclared as Hondra Baila | Rohu misdeclared as Nola | Croaker; Pama Croaker misdeclared as Poa | Calbasu misdeclared as Kalibaush | Problem(s);The label fails to bear the common or usual name of the food; if any there be. | Problem(s); The label fails to bear the common or usual name of the food; if any there be. | Olive Barb misdeclared as Shor Puti |
| Seamark (BD) Limited | 16-04 | Detention Without Physical Examination of Seafood Products That Appear To Be Misbranded | BANGLADESH | Cda Plot No. 50 ,Fouzdarhat Ind. Estate , Sagarika Road , Pahartali , Chittagong, Chittagong zila BANGLADESH | 10/04/2017 | 16 A - - 99 Fish, N.E.C. | Nola; Rohu; Labeo rohita | Problem(s); The label fails to bear the common or usual name of the food; if any there be. |
| Anraj Fish Products Industries, Ltd. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Opposit of Amin Jute Mil , Chittagong, Biozid Thana BANGLADESH | 09/18/2009 | 16 A - - 48 White Fish (Ciscoes, Lake Herring, Chubs, Tullibees, Etc.) | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Chalpata; Large Razorbelly Minnow; Salmostoma Bacaila | Meni Clean | Frozen Keski Fish | Chalpata; Large Razorbelly Minnow; Salmostoma Bacaila | Baila | SALMONELLA; | Enterd into fiars on 8/25/05 | SALMONELLA; |
| Apex Foods | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | 51-B(1) Shagarika Road , Pahartali , Chittagong, Chittagong BANGLADESH | 09/18/2009 | 16 A - D 99 Fish, N.E.C., Raw - Fresh, Frozen, Natural State | 16 A - - 99 Fish, N.E.C. | Frozen Freshwater Fish KESKI | (Carica soborna); (Piccola acciuga); 4/6/2006 | Kajoli/Pabda fish (DWPE date - 8/27/2004) Carica soborna fish (DWPE date - 4/7/2006) |
| ARK Sea Foods, Ltd. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | BSCIC Industrial Estate Faujdarhat , Chittagong, BD-10 BANGLADESH | 09/18/2009 | 16 A - - -- Fish | 16 X - - -- Aquaculture Harvested Fishery/Seafood Products | All raw fish products | All raw fish products | DWPE date - 12/27/2004 | DWPE date - 12/27/2004 |
| Coastal Seafoods Limited | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | B-11, BSCIC Industrial Estate , Sagarika Road , Chittagong, BD-10 BANGLADESH | 09/18/2009 | 16 A - - 48 White Fish (Ciscoes, Lake Herring, Chubs, Tullibees, Etc.) | 16 A - - 60 Sheatfish | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Frozen Ayre Fish (white fish) aka | Bacha aka | Frozen Ruhu Carp | Koral aka | Frozen Keski Fish aka | Frozen Magur Fish Steak aka | Frozen Pabda Fish Cock-up/Cockup (Lates calcarifer) | Frozen Tengra aka | Climbing Perch aka | Frozen Koral; Sliced | 3/28/94 | SALMONELLA; | 8/8/08 | SALMONELLA; | 9/3/98 | SALMONELLA; | 8/8/08 | SALMONELLA; | 8/25/05 | SALMONELLA; | 8/25/05 | SALMONELLA; | 8/8/08 | SALMONELLA; | 8/27/96 | SALMONELLA; | 7/27/09 | SALMONELLA; | 9/3/98 | SALMONELLA; |
| East West Trade International | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | 1368 East Nasirabad , Chittagong, BANGLADESH | 02/11/2019 | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Frozen Koral; Sliced | Frozen Ruhu Carp | 9/3/1998 | 9/3/1998 |
| Fresh Foods | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Elaipur , 5475 East Rupsha, Holding , Khulna, BANGLADESH | 09/18/2009 | 16 A - - 48 White Fish (Ciscoes, Lake Herring, Chubs, Tullibees, Etc.) | 16 A - - 99 Fish, N.E.C. | Raw pabda fish (DWPE date - 9/18/2001) Raw white fish (Dhani koral) (DWPE date - 11/27/2007) | SALMONELLA; | Raw white fish (Dhani koral) DWPE date - 11/27/2007 | SALMONELLA; | |
| Fresh & Green Frozen Food | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | 8/3 Shegun Bagicha , Dhaka, BANGLADESH | 01/04/2017 | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Keski | Bata Frozen Fish | Chanda Frozen Fish | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| Golden Harvest Sea Food & Fish Processing Limited | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Bokran Monipur, Bobanipur , Gazipur Sadar , Gazipur, Gazipur zila BANGLADESH | 09/18/2009 | 16 A - - 99 Fish, N.E.C. | 16 Y - - 04 Fish Roe, Fishery Products, n.e.c. | L.Balm Mastecembelus armatus | Hilsha Roe | SALMONELLA; | SALMONELLA; |
| Kuliarchar Cold Storage | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | KULIARCHAR , Kishoreganj, BANGLADESH | 11/30/2011 | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Keski Fish | Foli | Pabda Fish | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Bfdc Plot # 22, Block # B , Ichanagar, Karnafuly , Chattagram, BANGLADESH | 05/01/2013 | 16 A - - 15 Eel | 16 A - - 83 Goby | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | 16 X - - 45 Eel, Aquaculture Harvested Fishery/Seafood Products | 16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C., | 16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C., | Lesser Spiny Eel; Star Baim; Macrognathus aculeatus | "Baila"; Awaous guamensis; Goby | Dhani Koral | Lesser Spiny Eel; Star Baim; Macrognathus aculeatus | Hilsa | "Baila"; Awaous guamensis; Goby | Frozen Fish Koi | Lesser Spiny Eel; Star Baim; Macrognathus aculeatus | Dhani Koral | Hilsa | SALMONELLA; | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| Meghna Sea Foods | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Mohara Industrial Area , Kalurghat , Chittagong, None of the above BANGLADESH | 09/18/2009 | 16 A - - 48 White Fish (Ciscoes, Lake Herring, Chubs, Tullibees, Etc.) | 16 A - - 99 Fish, N.E.C. | Raw pabda fish DWPE date - 5/16/2006 | SALMONELLA; | Raw hilsa fish (DWPE daet - 7/28/2006) Raw lotia (DWPE date - 3/10/2006) Raw star baim (DWPE date - 3/10/2006) | SALMONELLA; | |
| Neptune Foods | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Sarkar Rhaban , 193 Ghatfarhadb , Chittagong, BANGLADESH | 09/18/2009 | 16 A - - 99 Fish, N.E.C. | Frozen Hilsha | 12/13/1994 |
| PREMIUM FISH & AGRO INDUSTRIES LTD. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Bolaura, Tuker Bazar (Jangail) , Sylhet Sadar, BANGLADESH | 11/23/2022 | 16 A - - 15 Eel | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 70 Shad, Alewife | Zig-Zag Eel; L. Baim; Mastacernbelus armatus | Sprat; Keski; Corica soborna | Sprat; Keski; Corica soborna | |
| RUPSHA FISH & ALLIED INDUSTRIES LIMITED | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Paikpara, Rakhalgachi , Bagerhat, BANGLADESH | 05/26/2015 | 16 A - - 48 White Fish (Ciscoes, Lake Herring, Chubs, Tullibees, Etc.) | 16 Y - - 04 Fish Roe, Fishery Products, n.e.c. | Hilsha (Ilish) | Hilsha Roe (Hilsa; Ilish) | DWPE: 4/8/2011 | DWPE: 8/28/2010 |
| Saidowla (Pvt.)Enterprise Limited | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | 68 Rangdhonu, Airport Road , Choukide Khi, Sylhet BANGLADESH | 09/18/2009 | 16 A - - 99 Fish, N.E.C. | Raw freshwater fish DWPE date -6/21/1999 | SALMONELLA; | |
| Seamark (BD) Limited | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Cda Plot No. 50 ,Fouzdarhat Ind. Estate , Sagarika Road , Pahartali , Chittagong, Chittagong zila BANGLADESH | 09/18/2012 | 16 A - - 09 Carp | 16 A - - 52 Gourmay, gourami | 16 A - - 58 Tilapia | 16 X - - 06 Tilapia, Aquaculture Harvested Fishery/Seafood Products | Koi Fish | Climbing Perch | Tilapia | Tilapia | Product described as "Frozen Koi Fish Block" and used product code 16A[][]09 at entry. Upon investigation; product found to actually be "Frozen Climbing Perch Block"; product code 16A[][]52. | Product described as "Frozen Koi Fish Block" and used product code 16A[][]09 at entry. Upon investigation; product found to actually be "Frozen Climbing Perch Block"; product code 16A[][]52. |
| Snow King Frozen Foods (Pvt), Ltd. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BANGLADESH | Mirpur 1 , 2-D Darus Salam Road , Dhaka, None of the above BANGLADESH | 10/14/2010 | 16 A - - 99 Fish, N.E.C. | Golda Fish | 2/10/03 | SALMONELLA; |
| Coastal Seafoods Limited | 16-119 | "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations" | BANGLADESH | B-11, BSCIC Industrial Estate , Sagarika Road , Chittagong, BD-10 BANGLADESH | 09/10/2009 | 16 A - - 70 Shad, Alewife | Hilsa (Shad) Steak | Importer: Four Star Import 1075 Flushing Ave Brooklyn, NY FEI# 3003109617 5/6/2005 |
| MASHUD FISH PROCESSING & ICE COMPLEX, UNIT-2 | 16-119 | "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations" | BANGLADESH | Bfdc Plot # 22, Block # B , Ichanagar, Karnafuly , Chattagram, BANGLADESH | 12/18/2025 | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 70 Shad, Alewife | 16 A - - 83 Goby | Oil Sardine; Sardinella longiceps | Hilsa Shad; Tenualosa ilisha | Tank Goby; Glossogobius giuris | IMPORTER: CK Frozen Fish and Food Inc., FEI# 3011442744 | IMPORTER: CK Frozen Fish and Food Inc., FEI# 3011442744 | IMPORTER: CK Frozen Fish and Food Inc., FEI# 3011442744 |
| Khulna Frozen Foods Export Limited | 16-124 | "Detention Without Physical Examination Of Aquaculture Seafood Products Due To Unapproved Drugs" | BANGLADESH | Bagmara, Naihati Union, Char Rupsha , Khulna, BANGLADESH | 10/23/2018 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | Shrimp | LEUCOMALACHITE GREEN; | LEUCOMALACHITE GREEN; |
| SOUTHERN FOODS LTD. | 16-124 | "Detention Without Physical Examination Of Aquaculture Seafood Products Due To Unapproved Drugs" | BANGLADESH | Elahipur, Rupsha , Khulna, BANGLADESH | 02/18/2021 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | Shrimp | OXOLINIC ACID; | OXOLINIC ACID; |
| TOHFA ENTERPRISE | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BANGLADESH | Dewan Bari , 166 SHANTINAGAR (1st Floor) , Dhaka, BD-13 BANGLADESH | 01/23/2017 | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | Lux Soft Touch | Dettol Soap | Problem(s); 12490 - Red Pigment (No Certifiable Equivalent); 12490 - non-permitted | Hansa Yellow (CI 11680; formerly certifiable as Ext.D&C Yellow#5) Non-Permitted | 11680 EXT. D&C YELLOW #5 (PIGMENT YELLOW 1); |
| UNILEVER BANGLADESH LIMITED | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BANGLADESH | 51, KALURGHAT HEAVY I/A , CHITTAGONG, BANGLADESH | 02/02/2023 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | Black Shine Shampoo | 7/20/2007 | 19140-FD&C YELLOW #5 (TARTRAZINE); 77266-D&C BLACK #2 (CARBON BLACK PIGMENT); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); |
| Zam Zam Cosmetic Industries Ltd | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BANGLADESH | 218 Mitford Rdmomtaz Market , Dhaka, BANGLADESH | 06/09/2023 | 50 N - - 18 Henna | 50 N - - 18 Henna | 53 G - - 06 Makeup Bases (Makeup Preparations, not for Eyes) | 53 G - - 06 Makeup Bases (Makeup Preparations, not for Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes) | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | Shahzadi Gold Henna | Shahzadi Henna Paste | Shahzadi Henna Paste | Shahzadi Gold Henna | Shahzadi Gold Henna | Shahzadi Henna Paste | Shahzadi Henna Paste | Shahzadi Gold Henna | Shahzadi Gold Henna | Shahzadi Henna Paste | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date; 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. | Non-permitted (Henna). DWPE date: 04/26/2011. Firm previously listed on deactivated Import Alert 53-19. |
| Aci | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | 48 Waterworks Road , Narayanganj, BANGLADESH | 04/12/2018 | 61 L - - 14 Chlorhexidine Gluconate | 61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic) | Savlon Antiseptic | Savlon Antiseptic Cream | The products appear to be unapproved new drugs as the product label contains drug claims | The products appear to be unapproved new drugs as the product label contains drug claims |
| ACI FOODS LTD | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | Aci Center, 245 Tejgaon Industial Area , P. T. Inst. , Dhaka, BANGLADESH | 04/12/2018 | 61 L - - 14 Chlorhexidine Gluconate | 61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic) | Savlon Antiseptic | Savlon Antiseptic Cream | The products appear to be unapproved new drugs as the product label contains drug claims | The products appear to be unapproved new drugs as the product label contains drug claims |
| Kohinoor Chemical Co.(Bd)Ltd | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | 36 Shahid Tejuddin Ahmed Soronitejgaon , Dhaka, BANGLADESH | 04/18/2016 | 53 E - - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring) | Tibet Pumpkin Hair Oil | Medical claims on product labeling |
| PRAN AGRO LTD | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | Pran-Rfl Center , 105 Middle Badda , Dhaka, BANGLADESH | 03/02/2018 | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | |
| PRAN Agro Ltd. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | No. 55 Natore City Bypass Road , Natore, BANGLADESH | 03/02/2018 | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | Curry Leaf Chanachur (blend of noodles; peanuts; pulses and rice) | |
| SPICY AGRO PRODUCTS LTD. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | Kotowali , 3 104 Roomghata Monzur Mohol, Floor , Chittagong, BANGLADESH | 04/12/2018 | 61 L - - 14 Chlorhexidine Gluconate | 61 X - - 06 Chlorcyclizine HCl (Anti-Histaminic) | Savlon Antiseptic | Savlon Antiseptic Cream | The products appear to be unapproved new drugs as the product label contains drug claims. | The products appear to be unapproved new drugs as the product label contains drug claims. |
| Sufia Chemical Industry | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BANGLADESH | 287/1 East Nakhal Para , Dhaka, Dhaka BANGLADESH | 12/02/2016 | 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Biddut Tooth Powder | Biddut Tooth Powder | |
| AG AGRO FOODS LIMITED | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Ahsan Tower 76 Bir Uttam A.K.Khanda , Kar Sarak Mohakhali C/A , Dhaka, BANGLADESH | 07/06/2026 | 21 G - - 11 Olives, Green, (Pit Fruit) | 24 A - - 29 Lablab Bean | 24 N - - 99 Leaf & Stem Vegetables, N.E.C. (Microgreen) | 24 N - - 99 Leaf & Stem Vegetables, N.E.C. (Microgreen) | 24 T - - 25 Spinach (Leaf & Stem Vegetable) | 24 T - - 99 Leaf & Stem Vegetables, N.E.C. | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | DESHI TATKA JOLPAI (GREEN OLIVE) | AG WHOLE BEAN (LABLAB BEANS) | DESHI TATKA BATHUA SHAK (LAMBS QUARTERS) Wild Spinach | DESHI TATKA LAL SHAK (RED AMARANTH) | DESHI TATKA LAL SHAK (RED AMARANTH) | DESHI TATKA BATHUA SHAK (LAMBS QUARTERS) Wild Spinach | DESHI TATKA LAL SHAK (RED AMARANTH) | CARBENDAZIM (MBC); | HEXACONAZOLE; THIAMETHOXAM; PYMETROZINE; CYPROCONAZOLE; CHLORPYRIFOS; | CHLORPYRIFOS; ATRAZINE; | CARBENDAZIM (MBC); | CARBENDAZIM (MBC); | CHLORPYRIFOS; ATRAZINE; | CARBENDAZIM (MBC); |
| DOWLA FOODS LIMITED | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Howapara , 67 Deshari , Sylhet, BD-G BANGLADESH | 07/17/2024 | 21 G - - 16 Chinese Red Date (Jujubes, Ziziphus Jujuba) (Pit Fruit) | Tok Boroi | CARBENDAZIM (MBC); THIAMETHOXAM; LAMBDA-CYHALOTHRIN; IMIDACLOPRID; |
| IFAD Multi Products Ltd | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Impl Factory , Boro Rangamatia, Ashulia, Savar , Dhaka, BD-C BANGLADESH | 11/03/2025 | 02 D - - 08 Rice, Fragrant, Processed (Packaged) | 02 D - - 99 Rice, Processed (Packaged) N.E.C. | Chinigura Rice | Chinigura Rice | CARBENDAZIM (MBC); TEBUCONAZOLE; | CARBENDAZIM (MBC); TEBUCONAZOLE; |
| M/S. RAJU AUTO RICE MILL | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Atahar, Bulonpur , Chapinawabganj, BANGLADESH | 07/12/2018 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | Aromatic Rice | TEBUCONAZOLE; |
| Maimuna Corporation | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Plot: B-8, 9 & 10 , BSCIC Industrial Area , Dhuliyakhal, Habiganj BANGLADESH | 11/17/2021 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | 02 D - - 99 Rice, Processed (Packaged) N.E.C. | 05 A - - 03 Rice Flakes,Puffs,Krispies,Loops Ready To Eat | Kalizara Aromatic Rice | Kalizara Aromatic Rice | Kalizara Aromatic Rice | CARBENDAZIM (MBC); CHLORPYRIFOS; PIRIMIPHOS-METHYL; TEBUCONAZOLE; | CARBENDAZIM (MBC); CHLORPYRIFOS; TEBUCONAZOLE; PIRIMIPHOS-METHYL; | CARBENDAZIM (MBC); PIRIMIPHOS-METHYL; CHLORPYRIFOS; TEBUCONAZOLE; |
| OVIJAT FOOD AND BEVERAGE INDUSTRIES LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Ramgonj Road, , Tupamari, , Nilphamari, Nilphamari zila BANGLADESH | 08/06/2025 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | Kalijeera Rice | FEI# 3015151578 is an office location, often mis-declared as Manufacturer at entry. FEI# 3017920070 is the manufacturing location. | CHLORPYRIFOS; |
| OVIJAT FOOD & BEVERAGE INDUSTRIES LTD | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | 139 Motijheel C/A, (6th Floor) , Dhaka, BANGLADESH | 08/06/2025 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | Kalijeera Rice | FEI# 3015151578 is an office location, often mis-declared as Manufacturer at entry. FEI# 3017920070 is the manufacturing location. | CHLORPYRIFOS; |
| PRAN Agro Ltd. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | No. 55 Natore City Bypass Road , Natore, BANGLADESH | 01/26/2024 | 07 H - - 08 Tropical/Subtropical Fruit Snacks, Fruit Snack Foods, Fried/Oil Cooked | 07 H - - 99 Fruit Snack Foods, n.e.c., Fried/Oil Cooked | 21 S - - 05 Mango (Subtropical and Tropical Fruit) | 33 J - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Fruit (without Chocolate) | 33 J - - 06 Flavored Candy, Soft (Live Savers, Etc.), with Fruit (without Chocolate) | Mango Bar (Barra de Mango) | Mango Bar (Barra de Mango) | Mango Bar (Barra de Mango) | Mango Bar (Barra de Mango) | Mango Bar (Barra de Mango) | CARBENDAZIM (MBC); | CARBENDAZIM (MBC); | CARBENDAZIM (MBC); | CARBENDAZIM (MBC); | CARBENDAZIM (MBC); |
| Sabjiana Limited | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Cda Plot Number 68 W P, Sagarika Road , Chittagong, Pahartali BANGLADESH | 07/16/2015 | 24 T - - 25 Spinach (Leaf & Stem Vegetable) | 24 T - - 99 Leaf & Stem Vegetables, N.E.C. | Red Amaranth/LAL SHAK | Red Amaranth/LAL SHAK | QUINALPHOS; | QUINALPHOS; |
| Unipex Trade Corporation | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BANGLADESH | Ghopal, Sunamganj Road , Tuker Bazar , Sylhet, BANGLADESH | 06/07/2024 | 25 J - - 23 Taro, Dasheen (Root & Tuber Vegetable) | Taro | CARBENDAZIM (MBC); |
| ANANDA CONFECTIONARY | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | 8 ABUL HASNAT ROAD , DHAKA, Satrawza BANGLADESH | 09/16/2009 | 03 A - - 99 Bread/Rolls/Buns, N.E.C. | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 Y - - 07 Zweiback, Toast | toast bread | toast biscuit | Toast biscuit | 6/8/05 | SALMONELLA; | 6/8/05 | SALMONELLA; | 6/8/05 | SALMONELLA; |
| Banga Millers Limited | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | No. 1166 Holding , Pabna, Rajshahi BANGLADESH | 02/24/2025 | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 T - - 99 Starch Snacks, n.e.c., Fried/Oil Cook | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | 23 A - - 99 Nuts, In Shell, N.E.C. | 37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C. | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | |
| Farhan Agro Processor | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Jhawgora, Araihazar , Narayanganj, BANGLADESH | 05/27/2021 | 28 A - - 12 Celery, Whole (Spice) | Celery Seed; "Ajmud" | |
| Janata food | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Dalairbagh , Sonargaon, Narayanganj BANGLADESH | 09/16/2009 | 28 A - - 08 Capsicums (Cayenne Chili, Hot Peppers), Whole (Spice) | 28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice) | 28 B - - 15 Coriander, Ground, Cracked (Spice) | 28 B - - 16 Cumin, Ground, Cracked (Spice) | 28 C - - 08 Capsicums (Cayenne Chili, Hot Peppers), Natural Extract or Flavor (Spice) | 37 B - - 02 Chili (Multiple Food Specialities, Side Dishes and Desserts) | chili powder | chili powder | coriander powder | ground cumin seeds | chili powder | Chili Powder | 9/27/06 | SALMONELLA; | 9/27/06 | SALMONELLA; | 1/30/08 | SALMONELLA; | 9/13/06 | SALMONELLA; | 9/27/06 | SALMONELLA; | 9/13/2006 |
| MARINE GOLD | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | H-6, R-14, Mohammadi Housing Society , Mohammadpur , Dhaka, Dhaka zila BANGLADESH | 02/25/2011 | 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C. | Onion/Garlic Spice Mix | SALMONELLA; |
| MASHUD AGRO PROCESSING FOOD PRODUCTS LTD. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Bfdc, Plot#11, Block-B , Ichanagar, Karnafuly, Chittagong , Chittagong, Chittagong BANGLADESH | 11/09/2021 | 03 A - - 01 Bagel Bread/Rolls | 03 A - - 15 Pita, Bread/Rolls/Buns | 03 A - - 99 Bread/Rolls/Buns, N.E.C. | 03 A - - 99 Bread/Rolls/Buns, N.E.C. | Dal Puri | Plain Paratha; Pita; Flat Bread | Dal Puri | Plain Paratha; Pita; Flat Bread | |
| PRAN AGRO LTD | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Pran-Rfl Center , 105 Middle Badda , Dhaka, BANGLADESH | 07/31/2013 | 03 F - - 02 Flavored or Party Crackers | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 T - - 99 Starch Snacks, n.e.c., Fried/Oil Cook | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | 23 A - - 99 Nuts, In Shell, N.E.C. | 28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice) | 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C. | 37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C. | Potato Crackers; "Galleta de Papa" | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Spice Powder (Chilli) | Haleen Mix | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | SALMONELLA; | SALMONELLA; |
| PRAN Agro Ltd. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | No. 55 Natore City Bypass Road , Natore, BANGLADESH | 10/01/2013 | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 T - - 99 Starch Snacks, n.e.c., Fried/Oil Cook | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | 23 A - - 99 Nuts, In Shell, N.E.C. | 28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice) | 37 B - - 99 Multiple Food Specialities, Side Dishes and Desserts, N.E.C. | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | Spice Powder (Chilli) | Hot Chanachur; Bombay Mix (snack mix of fried noodles; peanuts pulses and rice) | |
| PRAN Dairy Ltd. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | 1/1 Dairy Building, Ghorashal-Palash Rd , PRAN Industrial Park , Narshingdi, Bagpara, Palash BANGLADESH | 07/08/2013 | 03 F - - 02 Flavored or Party Crackers | 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C. | 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C. | 28 Y - - 99 Spices, Flavors and Salt Not Mentioned Elsewhere, N.E.C. | Potato Crackers; "Galleta de Papa" | Heleen Mix | Fish Masala Seasoning Mix | Fish Masala Seasoning Mix | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| Square Consumer Products ltd | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | 48 Mohakhali C/A , Dhaka, BANGLADESH | 06/04/2020 | 28 A - - 08 Capsicums (Cayenne Chili, Hot Peppers), Whole (Spice) | 28 A - - 15 Coriander, Whole (Spice) | 28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice) | 28 B - - 15 Coriander, Ground, Cracked (Spice) | 28 E - - 04 Curry Powder, without Salt | 28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C. | 28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C. | 28 F - - 04 Curry Powder, Ground, Cracked, without Salt | 28 F - - 99 Mixed Spice and Seasonings, Ground, Cracked, without Salt, N.E.C. | 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C. | 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C. | Chilli Powder | Coriander | Chilli Powder | Coriander | Curry Powder | Radhuni Panchforan | Spice Mix "Radhuni Chicken Masala" | Curry Powder | Spice Mix "Radhuni Chicken Masala" | Spice Mix "Radhuni Chicken Masala" | Spice Mix "Radhuni Chicken Masala" | |
| SQUARE FOOD & BEVERAGE LIMITED | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Meril Road , Pabna 6600 , Salgaria, BANGLADESH | 10/06/2015 | 28 A - - 08 Capsicums (Cayenne Chili, Hot Peppers), Whole (Spice) | 28 A - - 15 Coriander, Whole (Spice) | 28 B - - 08 Capsicums (Cayenne Chili, Hot Peppers), Ground, Cracked (Spice) | 28 B - - 15 Coriander, Ground, Cracked (Spice) | 28 E - - 04 Curry Powder, without Salt | 28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C. | 28 E - - 99 Mixed Spice and Seaonings, Without Salt, N.E.C. | 28 F - - 04 Curry Powder, Ground, Cracked, without Salt | 28 F - - 99 Mixed Spice and Seasonings, Ground, Cracked, without Salt, N.E.C. | 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C. | 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C. | 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C. | 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C. | Chilli Powder | Coriander; Whole | Chilli Powder | Coriander; Ground/Cracked | CURRY POWDER | Radhuni Panchforan | Spice Mix "Radhuni Chicken Masala" | CURRY POWDER | Spice Mix "Radhuni Chicken Masala" | Spice Mix; "Radhuni Fish Curry Masala" | Spice Mix "Radhuni Chicken Masala" | Spice Mix "Radhuni Chicken Masala" | Spice Mix; "Radhuni Fish Curry Masala" | |
| Unipex Trade Corporation | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BANGLADESH | Ghopal, Sunamganj Road , Tuker Bazar , Sylhet, BANGLADESH | 09/19/2024 | 24 A - - 99 Beans, Corn, and Pea, N.E.C. (Vegetable) | 24 T - - 72 Taro Leaves (Leaf & Stem Vegetable) | 25 J - - 23 Taro, Dasheen (Root & Tuber Vegetable) | SEEM BICHI; Bean Seeds; Lablab Purpureus | Narkeli Kochu (Giant Taro) | Narkeli Kochu (Giant Taro) | |
| Agriculture Marketing | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BANGLADESH | Property Heights 12 Mission Road , Dhaka, BANGLADESH | 03/29/2011 | 21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | Mango Juice | SULFUR DIOXIDE; |
| AK PURE FOOD & BEVERAGE LIMITED | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BANGLADESH | Pochimdi , Teghoria South Keraniganj Dhaka , Dhaka, BD-C BANGLADESH | 01/23/2025 | 20 A - - 10 Raisins (Dried Grapes) (Berry) | 20 B - - 10 Raisins, Dried or Paste | 20 B - - 20 Chokeberry, Dried or Paste | 20 F - - 10 Raisins (Dried Grapes) (Berry Purees) | GOLDEN RAISINS (KISMIS) | GOLDEN RAISINS (KISMIS) | GOLDEN RAISINS (KISMIS) | GOLDEN RAISINS (KISMIS) | |
| IFAD MULTI PRODUCTS | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BANGLADESH | 12 Biponon Commercial Area , Sonargaon Road , Dhaka, BANGLADESH | 06/24/2016 | 03 H - - 09 Fruit/Fruit Flavored Plain Cookies, Biscuits and Wafers | IFAD Orange Biscuit | Sodium Metabisulfite - undeclared sulfites | SODIUM METABISULFITE; |
| Kishwan snacks limited | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BANGLADESH | Plot No.# A-6, A-7, Block# B, BSCIC 1/E, Sholosahar , Nasirabad, Chittagong BANGLADESH | 03/18/2024 | 21 S - - 05 Mango (Subtropical and Tropical Fruit) | Mango bar (Tablette de Mangue) | SULFUR DIOXIDE; |
| Anraj Fish Products Industries, Ltd. | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Opposit of Amin Jute Mil , Chittagong, Biozid Thana BANGLADESH | 05/23/2018 | 16 A - - 99 Fish, N.E.C. | 16 A - - 99 Fish, N.E.C. | Lotiya Mix; Bombay Duck; Anchovy; Thryssa; Pink Shrimp; Harpadon nehereus; Coilia dussumien; Thryssa mystax; Pandalus borealis; | Meshali; Bata; Banded Gourami; Swamp Barb; Gangetic Leaffish; Labeo bata; Colisa fasciatus; Puntinus chola; Nandus nandus. | Problem(s): Principal Display Panel Nutrition Facts Panel; Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the Principal Display Panel are not accurate as required under 21 CFR 101.3. Section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information is not declared in accordance with 21 CFR 101.9. | Problem(s): Principal Display Panel Nutrition Facts Panel; Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the Principal Display Panel are not accurate as required under 21 CFR 101.3. Section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information is not declared in accordance with 21 CFR 101.9. |
| BAGERHAT SEAFOOD INDUSTRIES LIMITED | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Fakirhat Town Nowapara , Bagherhat, Khulna BANGLADESH | 10/02/2015 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Raw Black Tiger Shrimp | Raw Black Tiger Shrimp | Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07 | Product is misbranded under Section 403(q) in that trans fat is not listed; hairline is incorrect; bolding is not used; serving size and servings/container are not consistent [21 CFR 101.9]; Product is further misbranded under Section 403(i)(1)in that the label does not list each ingredient by its common or usual name [21 CFR 101.4]; Product is further misbranded under Section 403(e)(1) in that the label fails to bear the ingredient statement and the name and address of the manufacturer without other intervening material [21 CFR 101.2(e)] 12/5/07 |
| BANOFUL & CO. | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Industrial Area , 93 East Nasirabad , Chittagong, Chittagong BANGLADESH | 06/12/2024 | 03 A - - 13 Whole Wheat Bread/Rolls/Buns | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 Y - - 07 Zweiback, Toast | Banofil Special Toast | Banofil Special Toast | Banofil Special Toast | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. |
| Janata food | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Dalairbagh , Sonargaon, Narayanganj BANGLADESH | 10/02/2015 | 03 R - - 02 Cakes, filled (other than fruit or jelly) | 03 R - - 99 Sweet Goods Without Custard or Cream Filling, N.E.C. | 22 K - - 99 Other Fruits and Fruit Products, Other Fruit Juices or Concentrates, N.E.C. | Date Cake | Date Cake | Date Cake | The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07 | The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07 | The label fails to bear trans-fat declaration as required by Section 403(q) of the FD&C Act and 21 CFR 101.9(c)(2)(ii)and the serving size/servings Per container is inconsistent 101.9(b)(1). 10/30/07 |
| Kishwan snacks limited | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Plot No.# A-6, A-7, Block# B, BSCIC 1/E, Sholosahar , Nasirabad, Chittagong BANGLADESH | 01/27/2023 | 03 A - - 13 Whole Wheat Bread/Rolls/Buns | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C. | 03 Y - - 07 Zweiback, Toast | 03 Y - - 07 Zweiback, Toast | Banofil Special Toast | Banofil Special Toast | Special Toast Biscuits | SALTINE SALTED COOKIES | SALTINE SALTED COOKIES | Special Toast Biscuits | Banofil Special Toast | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label in descending order of predominance, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9. |
| kishwan snacks ltd | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | 397, Sk. Mujib Road, Pathantooly , Agrabad , Chittagong, BD-10 BANGLADESH | 06/08/2023 | 03 H - - 99 Plain Cookies,Biscuits and Wafers, N.E.C. | 03 M - - 99 Cookie,Biscuit,Wafer Dough, N.E.C. | SALTINE SALTED COOKIES | SALTINE SALTED COOKIES | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., the English language as well as any foreign languages). Required label information is not prominently placed to be read and understood by the ordinary individual under customary conditions of purchase and use: 21 CFR 101.15(a) and (b), 21 CFR 101.1, 21 CFR 101.2(c), and 21 CFR 101.7(h) and (f). The Net Quantity of contents does not appear as a distinct item on the Principal Display Panel (PDP): 21 CFR 101.7(f) and (h). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. 21 CFR 101.4(b)(16) does not provide for the use of the collective term “rising agents.” It is not clear whether “vegetable oil & fat (palm oil)” is an appropriate declaration in accordance with 21 CFR 101.4(b)(14) or whether it is a multicomponent ingredient. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9. The serving size does not appear to be based on the RACC for cookies (30 g), and in a common household measure as required by 21 CFR 101.9(b)(2) and 21 CFR 101.9(b)(7), respectively. The Nutrition Facts Label (NFL) is not in the format provided in 21 CFR 101.9; missing Total Sugars, Added Sugars, Potassium, and Vitamin D. Calories, Total Fat, Saturated Fat, and Protein declarations are not expressed in the appropriate increments as required by 21 CFR 101.9(c). Declaration of Calories from fat that is not provided for and the use of a footnote that is no longer permitted in the updated NFL. |
| KN Agro Processor | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Jhawgora , Araihazar , Narayanganj, Dhaka BANGLADESH | 03/05/2021 | 38 C - - 99 Dried Soup, N.E.C. | 38 Y - - 99 Soup, N.E.C. | Maggi Healthy Soups Thai | Maggi Healthy Soups Thai | Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)]. | Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Section 403(e)(2) of the Act because it fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count as required by 21 CFR 101.7. Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all statements required by or under authority of the Act to appear on the label must appear in English as well as the foreign language. Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not in accordance with 21 CFR 101.9. Section 403(i)(2) of the Act in that the ingredient list does not appear to meet the requirements in 21 CFR 101.4 and 101.22. For example: Vegetable oil is not declared by the specific common or usual name [21 CFR 101.4(b)(14)]. The terms "salt substitute, "acidity regulator," and "INS" numbers are not appropriate common or usual names of ingredients. In addition, "edible" is not part of the common or usual name for vegetable oil and "natural" is not part of the common or usual name of caramel color. As such, these terms are also intervening material [21 CFR 101.2(e)]. There is no provision for the use of the collective term "flavor enhancer." Onion and garlic are not permitted to be declared in the collective listing for spices [21 CFR 101.22(h)(3)]. |
| NESTLE BANGLADESH, LTD. | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | RAJENDRAPUR CANTONMENT , SREEPUR , GAZIPUR, BANGLADESH | 01/14/2021 | 04 C - - 07 Noodles, Instant | Maggi 2 Minute Noodles Masala | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the ingredient list does not meet the requirements in 21 CFR 101.4 and 101.22. Section 403(q) of the Act [21 U.S.C. §343(q)] because the labels appear to include nutrition information; however, the labels do not appear to include a Nutrition Facts label which meets the requirements in 21 CFR 101.9. The nutrition information appears to be in another country's format, which is not permitted. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains artificial coloring and fails to bear labeling stating that fact. Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages. |
| PRAN AGRO LTD | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BANGLADESH | Pran-Rfl Center , 105 Middle Badda , Dhaka, BANGLADESH | 04/10/2024 | 07 B - - 99 Fried Snack Foods, N.E.C. | 07 Y - - 99 Snack Foods Not Elsewhere Mentioned, N.E.C. | PRAN Chanachur Bombay Mix | PRAN Chanachur Bombay Mix | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the product label is false and misleading. Section 403(f) of the Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language), as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act in that the nutrition facts information is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act in that the product label is false and misleading. Section 403(f) of the Act because it contains information in a second language; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language), as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act in that the nutrition facts information is not as defined in 21 CFR 101.9. |
| GLOBAL DRUG SUPPLY | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BARBADOS | Unit 5-28 Warrens Industrial Pk , Saint Michael, BARBADOS | 09/01/2016 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Cjsc Vitex | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BELARUS | 2 Smirnov Str Minsk , Belarus, BELARUS | 11/30/2011 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | Beer Yeast Shampoo | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); 19140-FD&C YELLOW #5 (TARTRAZINE); 16255-PONCEAU 4R (C.I. ACID RED 18); |
| Jv Bielita Ltd | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BELARUS | Dekabristov 291 , Minsk, Minsk BELARUS | 11/30/2011 | 53 E - - 06 Shampoos (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | Henna Shampoo (for dark hair) | Henna Hair Balm (for dark hair) | 15985 - FD&C YELLOW #6 (SUNSET YELLOW FCF) - undeclared; 16255 - PONCEAU 4R (C.I. ACID RED 18) -non-permitted; 19140 - FD&C YELLOW #5 (TARTRAZINE) - undeclared; 42090 - FD&C BLUE #1 (BRILLIANT BLUE FCF) - undeclared | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF); 16255-PONCEAU 4R (C.I. ACID RED 18); 19140-FD&C YELLOW #5 (TARTRAZINE); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); | 15985 - FD&C YELLOW #6 (SUNSET YELLOW FCF) - undeclared; 16255 - PONCEAU 4R (C.I. ACID RED 18) - non-permitted; 19140 - FD&C YELLOW #5 (TARTRAZINE) - undeclared; 42090 - FD&C BLUE #1 (BRILLIANT BLUE FCF) - undeclared | 15985-FD&C YELLOW #6 (SUNSET YELLOW FCF); 16255-PONCEAU 4R (C.I. ACID RED 18); 19140-FD&C YELLOW #5 (TARTRAZINE); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); |
| I000 Kasibel | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BELARUS | Zukova Str 1 , Khoiniki, BELARUS | 09/16/2009 | 09 E - - 33 Caseinates | 6/17/05 | SALMONELLA; | |
| Laboratoires Ndv | 53-17 | "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination" | BELGIUM | B 1930 Zaventen , Brixtonlaan, BELGIUM | 04/13/2012 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | Nelly De Vust Slimming Oil | Staphyloccus xylosus |
| Laboratoria Qualiphar NV | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | BELGIUM | Rijksweg 9 , Bornem, Antwerp BELGIUM | 01/18/2011 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All drug products | All drug products | All drug products | All drug products | All drug products | All drug products | All drug products | All drug products | |
| Laboratoires Ndv | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BELGIUM | B 1930 Zaventen , Brixtonlaan, BELGIUM | 02/23/2012 | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Nelly De Vust Slimming Oil | Slimming Oil | Slimming Oil | Belgium | Belgium |
| Link2biz Nv | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BELGIUM | Unit 9a , Leuvensesteenweg 573 , Zaventem, Vlaams-Brabant BELGIUM | 03/07/2011 | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Melanic MT2 (Tanning Injectable) | Belgium |
| E Claes | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| M Bourquin | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Margaret Eden | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | B 82 , Amerikalei 159 , Antwerp, Antwerp BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| N Clan | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| S Kessler | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | B 82 , Amerikalei 159 , Antwerp, Antwerp BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Zita Tros | 66-57 | "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S." | BELGIUM | P O Box 108 , Antwerp, BELGIUM | 09/10/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All prescription drugs | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland | Shipper for Inhome Health Services; Switzerland; 9/29/1992 | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992Note | All prescription drugs 9/29/1992 Note |
| Acros Organics B.V.B.A. | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | BELGIUM | Janssen-Pharmaceuticalaan 3a , Geel West, Zone 2 , Geel, Antwerp BELGIUM | 09/30/2009 | 56 E - S 67 Oxytetracycline Hydrochloride (Tetracyclines), Active Pharm Ingred/Chems for Further Manuf | Oxytetracycline HCl | 11/2/2000 |
| ALCON-COUVREUR N.V. | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | BELGIUM | Rijksweg 14 , Puurs-Sint-Amands, Antwerp BELGIUM | 09/30/2009 | 66 R - S 08 Brinzolamide (Vasoconstrictor), Active Pharm Ingred/Chems for Further Manuf | Brinzolamide | 11/2/2000 |
| Pfizer Service Company | 66-66 | "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122" | BELGIUM | Zaventem , Hoge Wei 10 , Zaventem, Vlaams-Brabant BELGIUM | 09/30/2009 | 62 O - - 27 Doxazosin Mesylate (Anti-Hypertensive - Part II) | 11/2/2000 | |
| GHO AHK SPRL | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Boulevard Edmond Machte , Brussels, BELGIUM | 09/30/2025 | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 66 X - - 99 Homeopathic N.E.C. | 70 E - - 99 Additives, N.E.C. | 70 M - - 02 Horse Mixed Feed Ration | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | Haarlem Oil (Horse Supplement) | |
| Medichin N.V. | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Grote Baan 97/5 , Hasselt, Limburg BELGIUM | 11/29/2016 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Four Yellows | VI Formula | Nerve Restore | Pro-K | Hot Feet USA | Sinking | White Tiger | Tendon | Lady Plus Formula | Desert Fire | Bleeder USA | Bleeder USA | Four Yellows | White Tiger | Pro-K | Desert Fire | VI Formula | Lady Plus Formula | Hot Feet USA | Nerve Restore | Tendon | Sinking | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 | Importer: Noah'S Ark; FEI: 3007750328 |
| Reprobiol Sprl | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BELGIUM | Lorce 1 , Lorce, Liege BELGIUM | 12/10/2014 | 68 L - - 99 Disposable/Sigle Use Devices, NEC (Nonhuman) | 68 M - - 03 Cages, including oxygen cages (Nonhuman) | 68 M - - 07 Hematology Analyzer (Nonhuman) | 68 Z - - 99 Animal Medical Devices, NEC | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | STIMUFOL - Follicle Stimulating Hormone (FSH) | |
| Biocartis Nv | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BELGIUM | B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM | 12/07/2021 | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | SeptiCyte RAPID | |
| Coris Bioconcept | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BELGIUM | Rue Jean Sonet 4a , Isnes, Namur BELGIUM | 07/27/2021 | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | CoV-2 Rapid Antigen Test | Covelex | |
| MULTI-G BVBA | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BELGIUM | Lange Leemstraat 166 , Antwerp, Antwerp BELGIUM | 01/26/2021 | 83 Q - - KO Reagent, coronavirus serological | Multi-g COVID-19 IgG/IgM Rapid Test | |
| ZenTech SA | 89-08 | "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)" | BELGIUM | Avenue Pre-Aily 10 , Lige Science Park , Liege, Liege BELGIUM | 03/02/2021 | 83 Q - - KO Reagent, coronavirus serological | QuickZen COVID-19 IgM / IgG | |
| Casibeans | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BELGIUM | Schaarbeekstraat 23 A , Melsele, Oost-Vlaanderen BELGIUM | 05/03/2019 | 24 A - - 50 Blackeye Peas | Black-Eye Beans (Blackeye Peas) | THIODICARB; |
| De Prins bvba | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BELGIUM | Juniorslaan 69 , Leest, Antwerp BELGIUM | 04/06/2015 | 24 F - - 07 Pepper, Sweet (Fruit Used as Vegetable) | Yellow Peppers; Fresh | PIRIMICARB; |
| Vergo Kwekerijen BVBA | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BELGIUM | Maxburg Dreef 6 A , Hoogstraten, Antwerp BELGIUM | 08/09/2016 | 24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable) | Red Hot Finger Chilli Pepper | PYMETROZINE; PIRIMICARB; |
| Beneo-Orafti, S.A. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BELGIUM | Rue Louis Marechal 1 , Oreye, Liege BELGIUM | 05/09/2017 | 02 E - - 06 Wheat Flour, Gluten | 02 F - - 08 Gluten, Wheat | 18 E - - 01 Cereal Base Meat Extenders, Wheat Protein, Etc. | Vital Wheat Gluten | Vital Wheat Gluten | Vital Wheat Gluten | PIRIMIPHOS-METHYL; | PIRIMIPHOS-METHYL; | PIRIMIPHOS-METHYL; |
| Dicogel Begro | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BELGIUM | Tombrugstraat 8b , Ardooie, West-Vlaanderen BELGIUM | 05/23/2019 | 24 T - - 25 Spinach (Leaf & Stem Vegetable) | CHOPPED SPINACH | Triallate; |
| Dicogel N.V | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BELGIUM | Oostnieuwkerkestraat 2 , Staden, West-Vlaanderen BELGIUM | 09/16/2009 | 25 E - D 02 Carrots and Peas (Sweet) (Mixed Vegetables), Raw - Fresh, Frozen, Natural State | 25 E - T 02 Carrots and Peas (Sweet) (Mixed Vegetables), Packaged Food (Not Commercially Sterile) | frozen peas and carrots | 10/10/03 | PROCYMIDONE; | 10/10/03 | PROCYMIDONE; |
| SIROPERIE MEURENS | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BELGIUM | Kan 2 , Aubel, Liege BELGIUM | 01/10/2012 | 21 C - - 11 Berries and Core, Mixed, Flavored Jams, Jellies, Preserves, Marmalades, Butters and Candied | Pear Raspberry Spread | 721659 SEA-DO; Imazalil |
| Funghi Funghi NV | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BELGIUM | Brusselstraat 41 , Hoogstraten, Antwerp BELGIUM | 07/03/2025 | 25 P - - 07 Mushroom, Chanterelle, Whole (Button) (Fungi) | CHANTERELLE MUSHROOMS | |
| Jonathan P.V.B.A. | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BELGIUM | Antwerpse Steenweg 336 , Kapellen, BELGIUM | 06/03/2014 | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 37 K C E 99 Pastes, n.e.c., Glass, Commercially Sterile | Seitian (veg spread) | SEITAN IN OWN JUICE (VEGETABLE SPREAD) | GLASS OR CERAMIC (306x415) Reason; NON- RESPONSE - PROC 6/01/2010 | GLASS OR CERAMIC (306x415) Reason; NON-RESPONSE - PROC 9/10/2009 |
| Le Semeur Sa | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BELGIUM | Dreefvelden 40 , 2580 St. , Sint-Katelijne-Waver, Antwerp BELGIUM | 06/03/2014 | 24 A C E 14 Stringbeans, Glass, Commercially Sterile | 24 A C E 17 Pigeon Peas, Glass, Commercially Sterile | 24 A E E 99 Beans, Corn, and Pea, N.E.C. (Vegetable), Metal, Commercially Sterile | 24 A E E 99 Beans, Corn, and Pea, N.E.C. (Vegetable), Metal, Commercially Sterile | 24 T E E 07 Brussels Sprouts (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 07 Brussels Sprouts (Leaf & Stem Vegetable), Metal, Commercially Sterile | STRINGLESS BEANS (CUT) IN BRINE | EARLY JUNE PEAS (GRADED; NR. 1; NR. 2; NR. 3) | GREEN FLAGEOLETS BEANS | GREEN FLAGEOLETS BEANS (GREEN KIDNEY BEANS) | BRUSSELS SPROUT | BRUSSELS SPROUTS | REASON; Non-response - PROC DWPE date - 1985 | REASON; Non-response - PROC DWPE date - 1985 | REASON; Non-response - PROC DWPE date - 1985 | REASON; Non-response - PROC DWPE date - 1985 | REASON; Non-response - PROC DWPE date - 1985 | REASON; Non-response - PROC DWPE date - 1985 |
| N.V. Rena Konseerven | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BELGIUM | Wiekevorstsesteenweg 38 , Heist Op Den Berg, Antwerpen BELGIUM | 06/03/2014 | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 24 T E E 10 Cauliflower (Leaf & Stem Vegetable), Metal, Commercially Sterile | 25 J C E 06 Potato (Root & Tuber Vegetable), Glass, Commercially Sterile | 25 J C E 23 Taro, Dasheen (Root & Tuber Vegetable), Glass, Commercially Sterile | 25 J E E 06 Potato (Root & Tuber Vegetable), Metal, Commercially Sterile | 25 J E E 06 Potato (Root & Tuber Vegetable), Metal, Commercially Sterile | 25 J E E 23 Taro, Dasheen (Root & Tuber Vegetable), Metal, Commercially Sterile | 25 J E E 23 Taro, Dasheen (Root & Tuber Vegetable), Metal, Commercially Sterile | 25 J E E 23 Taro, Dasheen (Root & Tuber Vegetable), Metal, Commercially Sterile | CAULIFLOWER QUARTERS IN BRINE | CAULIFLOWER; QUARTERS | CAULIFLOWER FLOWERETTES IN BRINE | CAULIFLOWER; WHOLE | CALUIFLOWER WHOLE IN BRINE | CAULIFLOWER; FLOWERETS | YOUNG PEELED POTATOES | SALSIFY SPEARS | YOUNG PEELED POTATOES WHOLE IN BRINE | YOUNG PEELED POTATOES; WHOLE IN BRINE | SALSIFY CUT IN BRINE | SALSIFY; CUT | SALSIFY CUTS IN BRINE | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | GLASS OR CERAMIC (208x600; 211x412) Reason; NON-RESPONSE - PROC 9/10/2009 | SALSIFY SPEARS Notes; GLASS OR CERAMIC (211x412) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (600x600) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (602x601) Reason; NON-RESPONSE - PROC 9/10/2009 | GLASS OR CERAMIC (211x412) Reason; NON-RESPONSE - PROC 9/10/2009 | GLASS OR CERAMIC (302x514) Reason; NON-RESPONSE - PROC 9/10/2009 |
| Nieuwe Marie Thumas Sa Nv | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BELGIUM | Nekkerspoelstratt 477 , Mechlen, BELGIUM | 06/03/2014 | 24 A E E 10 Navy (White) Beans, (Baked Beans, Pork & Beans), Metal, Commercially Sterile | 24 C E E 10 Navy (White) Beans (Baked Beans, Pork & Beans), in Sauce, Metal, Commercially Sterile | 24 T - - 30 Endive (Cichorium endivia) (Leaf & Stem Vegetable) | WHITE BEANS (NATURAL) IN BRINE NAVY MICHIGAN BEANS (DRIED) | WHITE BEANS IN TOMATO SAUCE | Endives in brine | CAN - TINPLATE/STEEL OR ALUMINUM (211x300; 300x406; 401x411) Reason; NON- RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL OR ALUMINUM (211x300; 300x406; 401x411) Reason; NON- RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL OR ALUMINUM (214x405; 314x411) Reason; NON- RESPONSE - PROC 5/28/2010 |
| Sunnyland | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BELGIUM | Everdongenlaan 12 , Turnhout, Antwerp BELGIUM | 08/05/2015 | 21 V - - 04 Guava, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | 21 V - - 05 Mango, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | 21 V - - 19 Lychee, Lichee, Litchi, Leechee, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | Guava Juice Drink | Mango Juice Drink | Lychee Juice Drink | The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine. The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. Published on 08/05/2015 | Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9. Published on 08/05/2015 | Problem(s): The articles purport to be beverages containing vegetable or fruit juice but fail to bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Product labels bear information in at least two foreign languages; however, it does not appear that all required label information is presented in each of these foreign languages. The Guava Juice Drink label declares "Of course, no preservatives, artificial colors and flavors ever added." However, the statement of ingredients declares the color carmine; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format as required by 21 CFR 101.9.. Published on 08/05/2015 |
| W Cup Bvba | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BELGIUM | De Weven 15 , Beringenberingen, BELGIUM | 02/12/2016 | 40 E - - 40 Fruit Flavored Drink | 40 E - - 40 Fruit Flavored Drink | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | Recovery Drink Grapefruit | Recovery Drink Orange | Recovery Drink Grapefruit | Recovery Drink Orange | The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement. | The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement. | The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement. | The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(q)(5)(F) of the Act, for the following: • The Recovery Drink Orange and Recovery Drink Grapefruit Products list Magnesium (mineral) before the vitamins in accordance with 21 CFR 101.36(b)(2)(i)(B). • The Recovery Drink Orange and Recovery Drink Grapefruit Products list the vitamins in the wrong order. Vitamin E, its quantitative amount by weight per serving, and percent of the daily value should be listed before Vitamin B in accordance with 21 CFR 101.36(b)(2)(i)(B). • The supplement facts label fails to contain a heavy bar beneath the last dietary ingredients to be listed under 21 CFR 101.36(b)(3), as required under 21 CFR 101.36(e)(6). The articles are subject to refusal of admission pursuant to section 801(a) (3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that they appear to be misbranded within the meaning of section 403(i)(2)in that the Recovery Drink Orange and Recovery Drink Grapefruit products do not identify the source ingredient for each dietary ingredient by its' common or usual name in accordance with 21 CFR 101.4. The source ingredient may be listed either in the nutrition information (supplement facts label) or in a list of ingredient following the nutrition information. [21 CFR 101.36(d), 21 CFR 101.36(d)(1), and 21 CFR 101.4(g)]. Specifically, Vitamin B1, a synonym for Thiamin, must be listed as Thiamin (Vitamin B1) either within the Supplements Facts label or the Ingredient Statement. |
| Kempico C.V. | 99-45 | Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive | BELGIUM | Melkerijstraat 1 , Gierle, Antwerp BELGIUM | 03/28/2022 | 12 A - - 52 Cheese, Semisoft | Fontal Fiorella Cheese | SODIUM NITRITE CFR-172.175/177 (PRE); |
| Generic Viagra. Bz | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BELIZE | 5870 Manatee Drive , Button Wood Bay, BELIZE | 09/30/2009 | 65 P - - 02 Sildenafil Citrate (Regulator) | >>> Firm operates from website | |
| Meds India, Ltd. | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BELIZE | 20 Macaw Avenue , C.A. , Belmopan, Belize BELIZE | 09/30/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All drugs. GPI = DR. | |
| K & D Farms Co. Ltd | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BELIZE | Calcutta Village , Corozal, Corozal BELIZE | 03/05/2012 | 21 S - - 06 Papaya (Papaw) (Subtropical and Tropical Fruit) | Papaya | 732625 FLA-DO | THIOPHANATE-METHYL; |
| Zellyn Cell Research | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BERMUDA | P O Box H M 1120 , Hamilton, BERMUDA | 09/30/2009 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | Oxygenesis Live Cell Therapy. And all other products. 4/21/1994 | |
| Agropecuaria Chia Corp Bolivia S.A. | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BOLIVIA | Parque 1 Industrial Coronado , Carretera al Norte Km 9 , Santa Cruz de la Sierra, BO-S BOLIVIA | 08/02/2022 | 23 K - - 02 Sesame Seed (Edible Seed) | Sesame seeds | TEBUCONAZOLE; CARBENDAZIM (MBC); |
| Import & Export Santa Catalina INC. | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BOLIVIA | Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA | 09/16/2009 | 28 A - - 16 Cumin, Whole (Spice) | 28 B - - 16 Cumin, Ground, Cracked (Spice) | cumin | cumin | 2/10/09 | SALMONELLA; | 2/10/09 | SALMONELLA; |
| Sociedad Agropecuaria Industrial y Tecnica SAITE SRL | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BOLIVIA | Calle Esquillana No 4014 Zona Cosmos 79 , La Paz, El Alto BOLIVIA | 07/11/2022 | 23 K - - 02 Sesame Seed (Edible Seed) | 23 R - - 02 Sesame Seed (Edible Seed Paste) | 28 A - - 43 Sesame, Whole (Spice) | Sesame Seeds | Sesame Seeds | Sesame Seeds | |
| Import & Export Santa Catalina INC. | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BOLIVIA | Av. Petrolera Km. 4 1/2 # 1358 , Av. Ayacucho # 127 , Cochabamba, BO-C BOLIVIA | 10/02/2015 | 28 A - - 45 Spearmint, Whole (Spice) | 31 K - - 99 Tea, N.E.C. | Spearmint Leaves | Q'uillquina (Dried herbs for tea) | Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C, calcium, and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8)(ii) 10/31/07 | Product is misbranded under Section 403(a)(1) in that the amounts of Vitamin C; calcium; and iron are less than 80% of declared amounts; for tea) Product is further misbranded under Section 403(q) in that the nutrition label does not comply with format requirements in 21CFR 101.9 (type size and bolding requirements are not met; Total Fat/ Saturated Fat amounts are not correctly declared); Product is further misbranded in that the Nutrition Facts panel fails to base the nutrient information on the proper serving size [21 CFR 101.12(b)(2)]; Product is further misbranded in that the Nutrition Facts panel fails to declare the vitamins and minerals as specified by 21 CFR 101.9 (c)(8) (ii) 10/31/07 |
| Lozada United | 99-45 | Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive | BOLIVIA | Calle Brasil 665 , Cochabamba, BOLIVIA | 05/27/2025 | 52 A - C -- Foodware, Cookware & Tableware, (52A only) Bone China | 52 A - E -- Foodware, Cookware & Tableware, (52A only) Ceramic | 52 A - T -- Foodware, Cookware & Tableware, (52A only) Porcelain | Ceramic bowls tan in color with light green band | Ceramic bowls tan in color with light green band | Ceramic bowls tan in color with light green band | 1/25/2007 This firm is from deactivated import alert 52-08. | LEAD; | 1/25/2007 This firm is from deactivated import alert 52-08. | LEAD; | 1/25/2007 This firm is from deactivated import alert 52-08. | LEAD; |
| Alians Trade | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BOSNIA-HERCEGOVINA | Tuzla 75000 , Rudarska, BOSNIA-HERCEGOVINA | 09/16/2009 | 20 A - D 01 Blackberries (Berry), Raw - Fresh, Frozen, Natural State | 20 A - T 01 Blackberries (Berry), Packaged Food (Not Commercially Sterile) | 1/18/05 | PROCYMIDONE; | 1/18/05 | PROCYMIDONE; | |
| Klas dd Sarajevo | 99-39 | Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded | BOSNIA-HERCEGOVINA | Paromlinska 43 , Sarajevo, Sarajevo BOSNIA-HERCEGOVINA | 07/17/2025 | 03 R - - 50 Sweet Rolls Without Custard or Cream Filling | 03 R - - 50 Sweet Rolls Without Custard or Cream Filling | Homemade Baklava | Hurmasica Pastry | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food in English, required by 21 CFR § 101.3(a). Specifically, the product name “Doma?a baklava” is not the common or usual name in English of Homemade Baklava; Section 403(f) of the FD&C Act because the labeling contains foreign language representations (e.g., “tradicionalna receptura,” “…hrana puna ljubavi”) without the required full English translation, required by 21 CFR § 101.15(c)(2); Section 403(i)(2) of the FD&C Act due to its declaration of the color additive“E160d” without identifying the specific approved U.S. name, requires in 21 CFR Parts 73 or 74. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food in English, required by 21 CFR § 101.3(a). Specifically, the product name “Hurmašice” is not the common or usual name in English of Hurmasica Pastry; Section 403(f) of the FD&C Act because the labeling contains foreign language representations (e.g., “tradicionalna receptura,” “…hrana puna ljubavi”) without the required full English translation, required by 21 CFR § 101.15(c)(2); Section 403(i)(2) of the FD&C Act due to the use of several “E-numbers” (e.g.,E471, E270, E330, E202, E160) without providing the corresponding common or usual names required by 21 CFR § 101.4(a)(1). |
| AcquaMarine Commercio Ltda. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Av. Cesar Cals, No. 2600 000 , Fortaleza, Ceara BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen; raw lobster | DWPE date - 12/23/1997 | SALMONELLA; | Frozen, raw lobster DWPE date - 12/23/1997 | SALMONELLA; | DWPE date - 12/23/1997 | SALMONELLA; |
| Artico S.A. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Forte Santana, 67 69 , Rio Grande, Rio Grande do sul BRAZIL | 10/16/2012 | 16 A - - 13 Croaker | Croaker | SALMONELLA; |
| Beu Pescador Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Estrada Br 418 3 Km 16 , DO BOI) , Caravelas, Bahia BRAZIL | 09/18/2009 | 16 J - C 04 Lobster, Raw, Fresh, Refrigerated | 16 J - C 06 Spiny Lobster, Rock Lobster, Raw, Fresh, Refrigerated | 16 J - C 08 Slipper Lobster, Raw, Fresh, Refrigerated | 16 J - D 04 Lobster, Raw - Fresh, Frozen, Natural State | 16 J - D 06 Spiny Lobster, Rock Lobster, Raw - Fresh, Frozen, Natural State | 16 J - D 08 Slipper Lobster, Raw - Fresh, Frozen, Natural State | 16 J - T 04 Lobster, Packaged Food (Not Commercially Sterile) | 16 J - T 06 Spiny Lobster, Rock Lobster, Packaged Food (Not Commercially Sterile) | 16 J - T 08 Slipper Lobster, Packaged Food (Not Commercially Sterile) | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 | 11/15/2006 |
| Celpex Industria Do Pescado LTDA | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Avenida Parque Sul , Maracanau, Ceara BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | SALMONELLA; | Shrimp | SALMONELLA; | |
| Compescal - Comercio De Pescado Aracatiense Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Estrada Br 304 Km 54.5 , Aracati, Ceara BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | SALMONELLA; | Shrimp | SALMONELLA; | |
| Continental de Pesca | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Unknown , Mendes, Rio de Janeiro BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | Shrimp | 10/8/96 | SALMONELLA; | 10/8/96 |
| FRIGOMARIS LTDA. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Joao de Brito Lima Moura , 1226 Mandacaru , Joao Pessoa, Paraiba BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | SALMONELLA; | Shrimp | SALMONELLA; | |
| Friuba Frigorifico Irandu Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Matriz, Ave Beira Rio S.N. , 1 Andar, Vila Nova Conceicao , Iranduba, Amazonas BRAZIL | 09/18/2009 | 16 A - - 99 Fish, N.E.C. | Frozen; raw pirarucu loins | DWPE date - 3/1/1995 | SALMONELLA; |
| Icapel Icapui Pesca, Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Avenida Vinte Dois De Janeiro, No 5080 , Icapui, Ceara BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | SALMONELLA; | Shrimp | SALMONELLA; | |
| Infrapesca Ind De Frios E Pesca Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Snato Antonio 403 , Fortaleza, BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | DWPE date - 1/12/1995 | SALMONELLA; | DWPE date - 1/12/1995 | SALMONELLA; | DWPE date - 1/12/1995 | SALMONELLA; |
| Inpel Pescados, Industria, Comercio Importacao e Exportacao LTDA | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Chile 164 Ribeira , Natal, Rio Grande do norte BRAZIL | 10/08/2013 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen Lobster | Frozen Lobster | Frozen Lobster | SALMONELLA; | SALMONELLA; | SALMONELLA; |
| INTERMARIN SERVICIOS NAUTICOS LTDA | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Adolfo Caminha, 300 Sala 04 , Fortaleza, Ceara BRAZIL | 08/12/2010 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | DWPE date - 12/2/2008 | SALMONELLA; | DWPE date - 12/2/2008 | SALMONELLA; | DWPE date - 12/2/2008 | SALMONELLA; |
| M.A DE LIMA LOIOLA M.E. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Av. Voluntarios da Patria 150- Ballarina , Acarau, CE BRAZIL | 12/12/2014 | 16 J - - 06 Spiny Lobster, Rock Lobster | Frozen Lobster | |
| Mercantil Acarau Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Teresa Cristina 1053 , P.O. Box 400 , Fortaleza, Ceara BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen; raw lobster | DWPE date - 9/21/1998 | SALMONELLA; | Frozen, raw lobster DWPE date - 9/21/1998 | SALMONELLA; | DWPE date - 9/21/1998 | SALMONELLA; |
| MONTEIRO INDUSTRIA DE PESCADOS LTDA | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Manoel Teofilo Da Guia , Itarema, Ceara BRAZIL | 12/13/2011 | 16 J - - 06 Spiny Lobster, Rock Lobster | Lobster | SALMONELLA; |
| Mucuripe Pesca Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Chile, No. 66, , Bairro Ribeira , Natal, RN BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen, raw lobster DWPE date - 8/22/2005 | SALMONELLA; | Frozen, raw lobster DWPE date - 8/22/2005 | SALMONELLA; | DWPE date - 8/22/2005 | SALMONELLA; |
| Netuna Pescado Ltda | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | 373 Avenida Comendador Moraes , Pina Recife, Pernambuco BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | DWPE date - 2/12/1997 | SALMONELLA; | DWPE date - 2/12/1997 | SALMONELLA; | Frozen, raw lobster DWPE date - 2/12/1997 | SALMONELLA; |
| Netuno Alimentos S/a | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Avenida Marechal Mascarenhas De Moraes, 1571 , Recife, Pernambuco BRAZIL | 08/12/2010 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | DWPE date - 1/14/2010 | SALMONELLA; | DWPE date - 1/14/2010 | SALMONELLA; | DWPE date - 1/14/2010 | SALMONELLA; | |
| Pescampello Ind. E. Comm. Pescado Ltd. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Frei Sarafim , Touros Rio Grande, BRAZIL | 09/18/2009 | 16 J - - 04 Lobster | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Frozen; raw lobster | Frozen; raw lobster | Frozen; raw lobster | 8/30/1993 | DWPE date - 8/30/1993 | SALMONELLA; | DWPE date - 8/30/1993 | SALMONELLA; |
| Pina Intercambio Comercial Industrial E. Pesca S.A. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rodovia Arthur Bernardes Km 14 , Inscricao Estadual, BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | Shrimp | 1/14/98 | SALMONELLA; | 1/14/98 | SALMONELLA; |
| Secom Aquicultura Industria E Comercio S.A. | 16-81 | "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" | BRAZIL | Rua Fernando Simoes , Barbosa, Sao Paulo BRAZIL | 09/18/2009 | 16 J - - 05 Shrimp & Prawns | 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products | Shrimp | SALMONELLA; | Shrimp | SALMONELLA; | |
| BELEM - C. NORTE PESCADOS LTDA | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Rua Monsenhor Jose Maria Azevedo, 457 Sala 1 , Belem, Para BRAZIL | 06/28/2016 | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Snapper | |
| Blanke Industria de Pescado Ltda. | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Rua Historiador Luiz Do Nascimento, 450 , Recife, Pernambuco BRAZIL | 04/26/2013 | 16 J - - 06 Spiny Lobster, Rock Lobster | 16 J - - 08 Slipper Lobster | Lobster Tail | Lobster Tail | Decomposition | Decomposition |
| CAMPASA CAMAROES DO PARA S/A | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Rodovia Curuca Abade, Sn , Curuca, Para BRAZIL | 01/06/2016 | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Snapper | Problem(s) Decomposition |
| Costa Norte Comercio de Pescados Ltda | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Travessa Do Cruzeiro , Belem, Para BRAZIL | 12/26/2018 | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Snapper | Decomposition |
| Maricultura Pescados Com. Imp. e Exp. Ltda. | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Rua Vigario Xavier 38 , Acarau, Ceara BRAZIL | 03/25/2016 | 16 J - - 06 Spiny Lobster, Rock Lobster | Rock lobster tail | Problem; Decomposition |
| MONTEIRO INDUSTRIA DE PESCADOS LTDA | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Rua Manoel Teofilo Da Guia , Itarema, Ceara BRAZIL | 07/20/2021 | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Snapper | Decomposition |
| PRINCOMAR INDUSTRIA DE PESCA S/A | 16-105 | "Detention Without Physical Examination of Fish and Fishery Products from Specific Manufacturers/Shippers Due to Decomposition and/or Histamine, and/or Indole" | BRAZIL | Avenida Beira Mar SN , Sao Joao de Pirabas, Para BRAZIL | 03/21/2016 | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | Caribbean Red Snapper | Problem: Decomposition |
| Empresa Pesqueira de Barra de Sao Joao Ltda. | 16-119 | "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations" | BRAZIL | Avenida Amaral Peixoto 117 , Municipio de Casmiro , Barra De Sao Joao, Rio de Janeiro BRAZIL | 09/10/2009 | 16 A - - -- Fish | All histamine producing fish 9/5/2002 Importer: NW 43rd St., INC. (previously known as Collier County Produce dba Captain Jerry's Seafood) Miami, FL FEI# 3001853060 | |
| Atlantico Marinho Ltda | 16-120 | "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***" | BRAZIL | Rua Dona Arcelina de Oliveira, 444 , Imbiribeira, Recife, BRAZIL | 03/13/2009 | 16 Y - - 08 Shark Fin, Fishery Products, n.e.c. | dried shark fins | 4/17/2003 |
| CAMPASA CAMAROES DO PARA S/A | 16-120 | "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***" | BRAZIL | Rodovia Curuca Abade, Sn , Curuca, Para BRAZIL | 03/13/2009 | 16 A - - 51 Mahi Mahi | 4/6/2005 | |
| Frigorifico Camlombe Ind E Com. Ltd | 16-120 | "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***" | BRAZIL | Ave Colombe 3010 , Rio De Janeiro, BRAZIL | 03/13/2009 | 16 A - - 01 Anchovy | 16 A - - 05 Blue Fish | 16 A - - 07 Bonito | 16 A - - 21 Herring | 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.) | 16 A - - 37 Snapper (Red, Gray, Malabar, etc.) | 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.) | 16 A - - 51 Mahi Mahi | 16 A - - 69 Escolar | 16 A - - 70 Shad, Alewife | 16 A - - 71 Jack | 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22') | 16 A - - 76 Saury | 16 A - - 78 Wahoo | 16 A - - 79 Yellowtail, Amberjack | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | 4/1/2005 | |
| Mucuripe Pesca Ltda | 16-120 | "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***" | BRAZIL | Rua Chile, No. 66, , Bairro Ribeira , Natal, RN BRAZIL | 03/13/2009 | 16 A - - 42 Swordfish | 16 A - - 51 Mahi Mahi | 16 A - - 54 Marlin | 16 A - - 69 Escolar | 16 J - - 05 Shrimp & Prawns | 10/29/2003 | 10/29/2003 | 10/29/2003 | 10/29/2003 | 10/29/2003 | |
| Taiyo Industria De Pesca | 16-120 | "Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***" | BRAZIL | Rua Octavio Correa 119 , Santos, Sao Paulo BRAZIL | 03/13/2009 | 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.) | 16 A - - 51 Mahi Mahi | 16 A - - 54 Marlin | 16 A - - 69 Escolar | 8/8/2003 | 8/8/2003 | 8/8/2003 | 8/8/2003 | |
| Atum Do Brasil Captura Industria e Comercio Ltda. | 16-125 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN WITH PROPER LABELING) RAW FISH AND FISHERY PRODUCTS IN REDUCED OXYGEN PACKAGING DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION" | BRAZIL | Sebastiao Alves De Almeida Street, 469 , Itapemirim, Espirito Santo BRAZIL | 09/16/2009 | 16 A V C 17 Groupers, Vacuum or Modified Atmosphere Packaging, Raw, Fresh, Refrigerated | 16 A V C 37 Snapper (Red, Gray, Malabar, etc.), Vacuum or Modified Atmosphere Packaging, Raw, Fresh, Refrigerated | 16 A V C 42 Swordfish, Vacuum or Modified Atmosphere Packaging, Raw, Fresh, Refrigerated | 16 A V C 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Vacuum or Modified Atmosphere Packaging, Raw, Fresh, Refrigerated | Date removed - 10/7/2005 TTI method of control: Cryovac HP2700/BDX-9124 bags. | Date removed - 10/7/2005 TTI method of control: Cryovac HP2700/BDX-9124 bags. | Date removed - 10/7/2005 TTI method of control: Cryovac HP2700/BDX-9124 bags. | Date removed - 10/7/2005 TTI method of control: Cryovac HP2700/BDX-9124 bags. | |
| Juncao Inc. Com. De Pescados Ltda. | 16-127 | “Detention Without Physical Examination of All Seafood Due to Chloramphenicol” | BRAZIL | Rua Jose Bonifacio, 214 , Bairro Junc , Rio Grande, RS BRAZIL | 09/16/2009 | 16 J - - 01 Crab | DWPE date - 10/18/2006 | CHLORAMPHENICOL; | |
| Cadiveu Cosmeticos | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BRAZIL | Rua Guian 544 , Sao Paulo, Sao Paulo BRAZIL | 08/09/2010 | 53 C - - 06 Mascara (Eye Makeup Preparations) | 53 E C - 01 Hair Conditioners (Hair Preparations, Non-coloring), Cream | 53 E C - 07 Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring), Cream | Mascara Reconstrucao Imediata (not for eyelashes hair conditioner) | Mascara Reconstrucao Imediata (not for eyelashes hair conditioner) | Mascara Reconstrucao Imediata (not for eyelashes hair conditioner) | 16255 - PONCEAU 4R (C.I. ACID RED 18) - non-permitted | 16255-PONCEAU 4R (C.I. ACID RED 18); | 16255 - PONCEAU 4R (C.I. ACID RED 18) - non-permitted | 16255-PONCEAU 4R (C.I. ACID RED 18); | 16255 - PONCEAU 4R (C.I. ACID RED 18) - non-permitted | 16255-PONCEAU 4R (C.I. ACID RED 18); |
| Casa Granado Laboratorios, Farmacias e Drogarias S/A | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BRAZIL | Avenida Presidente Tancredo Neves, N 30 , Jardim Marajoara, Japeri , Rio De Janeiro, BRAZIL | 04/01/2016 | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) | Liquid Soap | Sabonete Phebo Naturelle bar soap | Sabonete Phebo Odor de Rosas Bar Soap | Granado Pharmacias Sabonete Glicerina Tradicional Liquid Soap | Sabonete Phebo Odor de Rosas Bar Soap | Sabonete Phebo Frescor Da Manha Bar Soap | C.I. 17200 - not certified; C.I. 16035 - not certified; C.I. 42090 - not certified; C.I. 19140 - not certified | 16035-FD&C RED #40 (ALLURA RED AC); 17200-D&C RED #33 (ACID FUCHSIN D); 19140-FD&C YELLOW #5 (TARTRAZINE); 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); | 15510-D&C ORANGE #4 (ORANGE II) %u2013 non certified | 15510-D&C ORANGE #4 (ORANGE II); | 16035-FD&C RED #40 (ALLURA RED AC) -non certified 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF) -non certified 17200-D&C RED #33 (ACID FUCHSIN D) -non certified 19140-FD&C YELLOW #5 (TARTRAZINE) -non certified | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); | 15510-D&C ORANGE #4 (ORANGE II) %u2013 non certified 16035-FD&C RED #40 (ALLURA RED AC) %u2013 non certified | 15510-D&C ORANGE #4 (ORANGE II); 16035-FD&C RED #40 (ALLURA RED AC); | 16035-FD&C RED #40 (ALLURA RED AC) -non certified 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF) -non certified 17200-D&C RED #33 (ACID FUCHSIN D) -non certified 19140-FD&C YELLOW #5 (TARTRAZINE) -non certified | 16035-FD&C RED #40 (ALLURA RED AC); 17200-D&C RED #33 (ACID FUCHSIN D); 19140-FD&C YELLOW #5 (TARTRAZINE); | 42090-D&C BLUE #4 (ALPHAZURINE FG) %u2013 non certified | 42090-D&C BLUE #4 (ALPHAZURINE FG); |
| De Classe Cosmetics Ltd | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BRAZIL | Estrade do Timbo 156-180 , Rio de Janero, BRAZIL | 10/25/2022 | 53 E - - 03 Hair Straighteners (Hair Preparations, Non-coloring) | Rio Hair Naturalizer System; Neutral and Color Enhanced | Concentrate extract of coulteria tinctoria vegetable dye - non-permitted | COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES); |
| Lasuvi Comercio Imp & Exp De Cos | 53-06 | "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations" | BRAZIL | Avenida Marcondes de Brito , Sao Paulo, Sao Paulo BRAZIL | 01/18/2011 | 53 E - - 03 Hair Straighteners (Hair Preparations, Non-coloring) | 53 E - - 03 Hair Straighteners (Hair Preparations, Non-coloring) | 53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C. | Keratin Smoothing Treatment | KERAPRIME SOLUTION | Keratin Smoothing Treatment | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF)– undeclared | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); | 60730-EXT. D&C VIOLET #2 (ALIZARINE VIOLET) -undeclared and non permitted | 60730-EXT. D&C VIOLET #2 (ALIZARINE VIOLET); | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF)– undeclared | 42090-FD&C BLUE #1 (BRILLIANT BLUE FCF); |
| Michelle Gleneuine | 54-16 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT" | BRAZIL | Av. Canal Marapendi No , 4100/ 1105 BL1 , Rio de Janeiro, RJ BRAZIL | 05/11/2015 | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement | PEB One and PEB Two Capsules (Brand Renutryent) Dietary Supplement | Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL. | Product contains undeclared Fenproporex HCL and Chlordiazepoxide HCL. |
| Cartibras Beneficiadora De Produtos Animais Ltda | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | BRAZIL | Rua Natal Braghini, 975 , Iomere, Santa Catarina BRAZIL | 04/13/2020 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | |
| Lima & Pergher Industria e Comercio S/A | 66-40 | "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs" | BRAZIL | Avenida Airton Borges Da Silva, 740 , Uberlandia, Minas Gerais BRAZIL | 07/15/2016 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | All Drugs and Drug Products;Problem(s): (GMP) Good Manufacturing Practices | |
| Casa Granado Laboratorios, Farmacias e Drogarias S/A | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BRAZIL | Avenida Presidente Tancredo Neves, N 30 , Jardim Marajoara, Japeri , Rio De Janeiro, BRAZIL | 10/04/2013 | 53 D - - 03 Powders (Dusting and Talcum, excluding Aftershave Talc) (Fragrance Preparations) | 53 H - - 99 Other Manicuring Preparations, N.E.C. | 53 L - - 04 Foot Powders and Sprays (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder) | Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder) | Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder) | Polvilho Antisseptico-Pink (Pink Antiseptic Foot Powder) | |
| Fitoterapicos A Cura | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BRAZIL | Rua Estrela Dione, 340 , Contagem, Minas Gerais BRAZIL | 09/30/2009 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | GPI-DR Emagrece Sim Dietary Supplements (all Levels) 12/12/2005 This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application. | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | Emagrece Sim Dietary Supplement, 12/23/2005 | |
| PHYTOTHERM SIM | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BRAZIL | Rua Estrela Dione, 300 , Contagem, Minas Gerais BRAZIL | 09/30/2009 | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | GPI-DR Emagrace Sim Dietary Supplement (all levels) 12/23/2005 This website makes direct reference to treatmenst for cancer cures as well as treatments for AIDS and diabetes. Additionally, a letter that accompanies the imported product states in Spanish that this product has been used to treat patients with cancer, leukemia, and HIV positive obtaining good results even on those patients with terminal conditions. We are not aware of any substantial scientific evidence that establishes that this product is generally recognized as safe and effective for its intended use. This product is not the subject of an approved new or abbreviated new drug application. | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | Emagrece Sim Dietary Supplement (all Levels); 12/23/2005 | |
| Pineda Laboratorio | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BRAZIL | Rua Monte Alegre 1142 , Sao Paulo, Sao Paulo BRAZIL | 04/23/2020 | 53 - - - -- Cosmetics | 65 Q - - 02 Botox | 65 Q - - 07 Myobloc | Botulinum Toxin Type A & B | Botulinum Toxin Type A & B | Botulinum Toxin Type A & B | |
| Zipmed Mesoone | 66-41 | Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S. | BRAZIL | Rua Erico Mota, 1149a , Fortaleza, Ceara BRAZIL | 09/08/2010 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | All Drug Products; NOTE: Drug products from Zipmed Mesoone are intended for injection and are therefore also subject to the guidance found in Import Alert #62-05.; Brazil | |
| Unibeleza Industria E Comercio De Cosmeticos Ltda | 66-79 | "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection" | BRAZIL | Rua Salomao Camargos 2611 , Belo Horizonte, Minas Gerais BRAZIL | 10/18/2022 | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs | 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products | All Drug and Drug Products |
| Lavizoo-Lab Vitamins and Zootechnics | 68-19 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS" | BRAZIL | Rua Jose Antonio Da Silva Junior 900 , Distr. Industrial Cep, Distr. Industrial CEP BRAZIL | 07/31/2024 | 63 B - - 35 Clenbuterol (Bronchodilator) | 63 B - - 99 Bronchodilator N.E.C. | Clenbuterol | Clenbuterol | |
| Agropecuaria Schio | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BRAZIL | Br 285 Km 124 , Vacaria, BR-RS BRAZIL | 08/06/2010 | 20 N - - 01 Apple (Core Fruit) | Apples | 620189 Phi-Do | CHLORPYRIFOS; |
| D.S. Comercio de Produtos Agricolas Ltda | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BRAZIL | Estr. Guilherme Joao Frederico Kruger S/N , KM 13 Terreo Sitio Nativa , Santa Maria de Jetiba, Espirito Santo BRAZIL | 04/14/2026 | 25 T - - 24 Ginger Root (Microgreen) | 28 A - - 19 Ginger, Whole (Spice) | 28 C - - 19 Ginger, Natural Extract or Flavor (Spice) | Ginger Root | Ginger Root | Ginger Root | Problem(s): Quizalofop Ethyl | Problem(s): Quizalofop Ethyl | Problem(s): Quizalofop Ethyl |
| Intermelon Comercial Exp. E Imp | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BRAZIL | Zona Rural , Fazenda Mossoro, S/N, Sitio Pau Bran , Fortaleza, Amapa BRAZIL | 09/16/2009 | 22 A - B 99 Vine Fruit, N.E.C., Raw, Fresh, Ambient | 22 A - C 99 Vine Fruit, N.E.C., Raw, Fresh, Refrigerated | Galia | IMAZALIL; | Galia | IMAZALIL; | |
| Salvio Rodrigues Proenca | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BRAZIL | Tres Pedrinhas , Sao Joaquim , Santa Catarena, BRAZIL | 08/06/2010 | 20 N - - 01 Apple (Core Fruit) | Apples | 620189 Phi-Do | CHLORPYRIFOS; |
| Vds Export Ltda | 99-05 | "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides" | BRAZIL | Br 428, S/N Loteamento Boa Esperanca , Petrolina Pe, BRAZIL | 08/01/2011 | 20 A - - 09 Grapes (Berry) | Grapes | 656546 PHI-DO; 838046 – PHI-DO | LAMBDA-CYHALOTHRIN; CYPROCONAZOLE; |
| Citrovita Agro Industrial Ltda | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rodovia Comendador Pedro Monteleone - Sp 351 Km 206.5 , Catanduva, Sao Paulo BRAZIL | 01/24/2012 | 20 K - - 06 Orange, Citrus Fruit Juices or Concentrates | Orange Juice | 732987 PHI; 732981 PHI; 732563 PHI-DO | CARBENDAZIM (MBC); |
| Coperaguas Cooperativa Agroindustrial | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Avenida Olacyr Francisco Moraes, 1621 , Campo Novo Do Parecis, Mato Grosso BRAZIL | 02/22/2022 | 24 A - - 50 Blackeye Peas | 24 B - - 50 Blackeye Peas, Dried or Paste | Blackeye Peas | Blackeye Peas | ACETAMIPRID; | ACETAMIPRID; |
| Floryl Agricola Ltda | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rod. Br 020 S/N Km 304 , Jaborandi, Bahia BRAZIL | 11/04/2025 | 23 K - - 09 Quinoa Seed (Edible Seed) | Brazilian White Quinoa | CHLORFENAPYR; |
| Guacira Alimentos Ltda | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rua Escritor Erico Verissimo, 208 , Uruguaiana, Rio Grande do sul BRAZIL | 12/04/2024 | 02 D - - 02 Rice, Plain (White or Polished) Processed (Packaged) | 02 D - - 03 Rice, Enriched Processed (Packaged) | 02 D - - 99 Rice, Processed (Packaged) N.E.C. | Enriched Long Grain Parboiled Rice | Enriched Long Grain Parboiled Rice | Enriched Long Grain Parboiled Rice | ACETAMIPRID; TEBUCONAZOLE; | ACETAMIPRID; TEBUCONAZOLE; | ACETAMIPRID; TEBUCONAZOLE; |
| Louis Dreyfus Company Sucos S.A | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rodovia Sp332 164 Km 164 , Engenheiro Coelho, Sao Paulo BRAZIL | 10/23/2012 | 20 H - - 06 Orange, Dried or Paste | Orange Peels | 76470 FLA-DO | TEBUCONAZOLE; |
| Nestle Brasil Ltda. - Rio Pardo Factory | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rua Henry Nestle , Sao Jose Do Rio Pardo, Sao Paulo BRAZIL | 09/16/2009 | 05 A - - -- Breakfast Food Ready Eat | 05 Y - - 99 Cereal Preparations Not Elsewhere Mentioned, N.E.C. | 40 B - - -- Cereal (Baby) | Primiphos-methyl | Primiphos-methyl | Primiphos-methyl | |
| Tropfruit Nordeste SA | 99-08 | "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides" | BRAZIL | Rodovia Br 101 150 Km 150 Km 150 , Estancia, Sergipe BRAZIL | 01/31/2012 | 20 K - - 06 Orange, Citrus Fruit Juices or Concentrates | Orange Juice | 732614 NYK-DO | CARBENDAZIM (MBC); |
| Bayonne Alimentos | 99-19 | "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella" | BRAZIL | Rua Paul Garfunkel, 455 , Curitiba, Parana BRAZIL | 09/16/2009 | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 I - - 99 Fiber, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | Fiber life supplement with calcium | Fiber life supplement with calcium | Fiber life supplement with calcium | 4/27/07 | SALMONELLA; | 4/27/07 | SALMONELLA; | 4/27/07 | SALMONELLA; |
| Bilateral Commercio Import | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Unknown Street , Sao Paulo, BRAZIL | 09/16/2009 | 16 J - - 05 Shrimp & Prawns | Frozen Shrimp | DWPE Date: 8/10/1990 | SULFUR DIOXIDE; |
| Ciapesc Companhia Amazonica De Pesca | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Rodovia Arthur Bernardes Km 14.5 , Belem, Para BRAZIL | 09/16/2009 | 16 J - - 05 Shrimp & Prawns | Frozen Shrimp | DWPE Date: 8/5/1994 | SULFUR DIOXIDE; |
| Duas Rodas industrial Ltda | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Rodolfo Hufenussler Street, 755. Centro , Jaragua Do Sul, SC BRAZIL | 09/16/2009 | 21 T - - 02 Banana, Dried or Paste | 4/19/06; dehydrated banana flakes | SULFUR DIOXIDE; | |
| Incopesca Industria E Comercio De Pesca Do piaui SA | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Rua Jonas Correia 352 , Fortaleza, Ceara BRAZIL | 09/16/2009 | 16 J - - 04 Lobster | 16 J - - 05 Shrimp & Prawns | frozen rock lobster tail | Frozen Shrimp | 7/17/1991 | SULFUR DIOXIDE; | 5/31/91; shipper for Interfrios Intercambio FEI 1000124824 | SULFUR DIOXIDE; |
| Industrial E Comercial Jandaia Ltda | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Br 53 , Pacajus, Ceara BRAZIL | 10/10/2019 | 21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | Acerola Juice | 9/22/2009 |
| Interfrios Intercambio Frios S.A. | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Avenida Vicente De Castro, 5000 , Fortaleza, Ceara BRAZIL | 09/16/2009 | 16 J - - 05 Shrimp & Prawns | Frozen Shrimp | 5/31/1991 | SULFUR DIOXIDE; |
| Sucos Do Brasil S/A | 99-21 | Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents | BRAZIL | Br Km 116 54 , Pacajus, Ceara BRAZIL | 10/23/2019 | 21 V - - 01 Acerola, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | Acerola Juice | 9/22/2009 |
| Frutop Productora De Alimentos S/A | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BRAZIL | Rua Senador Jaguaribe 210 Centro , Fortaleza, Cerara BRAZIL | 06/03/2014 | 23 F C E 99 Nut, Topping, N.E.C., Glass, Commercially Sterile | 30 Y - - 02 Coconut Milk Beverage Base | CREAM OF COCONUT | Cream of coconut | CAN - TINPLATE/STEEL (210x312; 210x413) Reason; NON-RESPONSE - PROC 9/10/2009 | CAN - TINPLATE/STEEL (210x312; 210x413) Reason; NON-RESPONSE - PROC 6/01/2010 |
| Industria De Conservas Luca Ltda. | 99-37 | "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES" | BRAZIL | Estrada Municipal Km 10 , Mogi Das Cruzes, Estado De Sao Paulo BRAZIL | 06/03/2014 | 25 P C E 01 Mushroom, Common (Agaricus Bisporus), Whole (Button) (Fungi), Glass, Commercially Sterile | 25 P E E 01 Mushroom, Common (Agaricus Bisporus), Whole (Button) (Fungi), Metal, Commercially Sterile | 25 P E E 01 Mushroom, Common (Agaricus Bisporus), Whole (Button) (Fungi), Metal, Commercially Sterile | 25 Q C E 01 Mushroom, Common (Agaricus Bisporus), Pieces and Stems, Sliced, Glass, Commercially Sterile | 25 Q E E 01 Mushroom, Common (Agaricus Bisporus), Pieces and Stems, Sliced, Metal, Commercially Sterile | 25 Q E E 01 Mushroom, Common (Agaricus Bisporus), Pieces and Stems, Sliced, Metal, Commercially Sterile | 25 Q E E 01 Mushroom, Common (Agaricus Bisporus), Pieces and Stems, Sliced, Metal, Commercially Sterile | 25 Q E E 01 Mushroom, Common (Agaricus Bisporus), Pieces and Stems, Sliced, Metal, Commercially Sterile | 25 R - - -- Fungi;Broken or Kibbled (eg,Mushroom,Truffle,etc) | 25 S - - -- Fungi Products,N.E.C. | MUSHROOMS (WHOLE) IN BRINE | MUSHROOM (WHOLE) IN BRINE | MUSHROOMS (BOTTONS) IN BRINE | MUSHROOMS (SLICE) IN BRINE | MUSHROOMS (STEM) IN BRINE | MUSHROOMS (PIECES | MUSHROOM (SLICE) IN BRINE | MUSHROOM (PIECES & STEM) IN BRINE | Mushrooms in brine | Mushrooms in brine | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 9/10/2009 | Reason; NON-RESPONSE - PROCCAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 6/2/2010 | Reason; NON-RESPONSE - PROC CAN - TINPLATE/STEEL (301x407; 401x411; 603x700) 6/2/2010 |
Showing the first 400 of 14,154 records. Every record has its own page, with its source and the quoted line that states it; these list the rest.
- Records 1–400Afghan Attaran Food & Beverage Company · 99-08 · AFGHANISTAN … Industria De Conservas Luca Ltda. · 99-37 · BRAZIL
- Records 401–800Amafil Ind. Com. Alimentos Ltda · 99-39 · BRAZIL … STAY WYLD ORGANICS LTD · 66-41 · CANADA
- Records 801–1,200Stephen Health Agency · 66-41 · CANADA … Salmones Antartica Sa · 16-39 · CHILE
- Records 1,201–1,600Salmones Aucar Ltd · 16-39 · CHILE … Jinhua Mingmei Cosmetics Co Ltd · 53-06 · CHINA
- Records 1,601–2,000Jinhua Sanctity Cosmetic Co., Ltd. · 53-06 · CHINA … LMZ INTERNATIONAL LTD · 66-41 · CHINA
- Records 2,001–2,400Long Zhu · 66-41 · CHINA … China Meheco Qingdao Import & Export Corp · 80-04 · CHINA
- Records 2,401–2,800Dalian Anbao Latex Factory · 80-04 · CHINA … Shenzhen Beierkang Technology Co. Ltd. · 89-08 · CHINA
- Records 2,801–3,200SHENZHEN BEPERFECT TECH. CO., LTD. · 89-08 · CHINA … NINGBO LIWAH PLANT EXTRACTION TECHNOLOGY LIMITED · 99-08 · CHINA
- Records 3,201–3,600Ningbo Shunkin Health Food Co., Ltd., · 99-08 · CHINA … Hunan duoying agricultural science and Technology Co.,Ltd · 99-23 · CHINA
- Records 3,601–4,000JIANGHUA YAO AUTONOMOUS COUNTY YONGFU BIOLOGICAL TECHNOLOGY CO.LTD · 99-23 · CHINA … PolyPeptide Laboratories A/S · 66-66 · DENMARK
- Records 4,001–4,400Vetcur Biotec Aps … Netsanet Exporter · 99-19 · ETHIOPIA
- Records 4,401–4,800Rahel Yirgu Tola · 99-19 · ETHIOPIA … G.S. PAPANIKOLAOU BROS O.E. · 66-41 · GREECE
- Records 4,801–5,200GIAMKO SMPC · 66-41 · GREECE … South Project LTD · 99-19 · HONG KONG SAR
- Records 5,201–5,600SSH International Trading Co · 99-19 · HONG KONG SAR … BAIDYANATH AYURVED BHAWAN PVT LTD · 66-41 · INDIA
- Records 5,601–6,000Ban Labs Ltd · 66-41 · INDIA … H&R International · 99-08 · INDIA
- Records 6,001–6,400Harshad Mango Products Pvt Ltd · 99-08 · INDIA … Tit-Bit Foods (India) Pvt. Ltd. · 99-19 · INDIA
- Records 6,401–6,800Trade Wings International · 99-19 · INDIA … Omj Manufacturing Ltd. · 66-66 · IRELAND
- Records 6,801–7,200Pfizer Ireland Pharmaceuticals · 66-66 · IRELAND … Narumiya Co.,Ltd. · 16-120 · JAPAN
- Records 7,201–7,600Oak K.K., Corporation · 16-120 · JAPAN … J&C Trading Co Ltd · 66-41 · KOREA (THE REPUBLIC OF)
- Records 7,601–8,000J&P International Co.Ltd · 66-41 · KOREA (THE REPUBLIC OF) … Archid S.A. · 66-66 · LUXEMBOURG
- Records 8,001–8,400Biotech Industry · 89-08 · LUXEMBOURG … Probelco S.A. de D.V.
- Records 8,401–8,800Prosa Productos Naturales, S.A. de C.V. … CARLOS CHAVEZ ROJAS · 99-05 · MEXICO
- Records 8,801–9,200Carlos Cortez Navarro · 99-05 · MEXICO … Horacio Leonardo Jimenez Carrillo · 99-05 · MEXICO
- Records 9,201–9,600HORTALIZAS ASIATICAS S.A. DE C.V. · 99-05 · MEXICO … Miguel Angel Laguna Sanchez · 99-05 · MEXICO
- Records 9,601–10,000Miguel Angel Perez Zerega · 99-05 · MEXICO … Agroindustria La Colosal del Centro SPR de RL · 99-08 · MEXICO
- Records 10,001–10,400Alberto Hernandez · 99-08 · MEXICO … Comercializadora Cadena · 99-39 · MEXICO
- Records 10,401–10,800Comercializadora Gofer S.A. de C.V. · 99-39 · MEXICO … WILBERTO FERNADO VARGAS GARCIA · 99-05 · NICARAGUA
- Records 10,801–11,200COPROEXNIC RL · 99-19 · NICARAGUA … Agricola La Venta S.A. · 99-05 · PERU
- Records 11,201–11,600Agrosymar · 99-05 · PERU … Tam Tam Ooo · 99-21 · RUSSIA
- Records 11,601–12,000Dawn Of Communism · 99-37 · RUSSIA … GLOBAL SEA FOODS (Pvt) Ltd · 16-125 · SRI LANKA
- Records 12,001–12,400Global Sea Foods Pvt Ltd · 16-125 · SRI LANKA … BAI XIAN WU ENTERPRISE COMPANY LIMITED · 99-08 · TAIWAN
- Records 12,401–12,800BOILING POINT GROUP, INC. TAIWAN BRANCH · 99-08 · TAIWAN … Luxco Foods Company, Limited · 99-37 · THAILAND
- Records 12,801–13,200M & S Ltd., Part. · 99-37 · THAILAND … Beauty Without Cruelty Ltd · 53-06 · UNITED KINGDOM
- Records 13,201–13,600Natural Products Limited · 53-06 · UNITED KINGDOM … Grupo VPAS C.A. · 16-120 · VENEZUELA
- Records 13,601–14,000PESCAMARCA PESCADORES MARINOS C.A. · 16-120 · VENEZUELA … Mekong Joint Stock · 99-08 · VIETNAM
- Records 14,001–14,154MINH DUNG PRIVATE ENTERPRISE · 99-08 · VIETNAM … ZIM TUCKSHOP · 66-41 · ZIMBABWE
Where this came from
Every record above links the page it was taken from and quotes the sentence that states it. These are the 31 sources this dataset was assembled from.
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_259.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_263.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_265.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1173.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1131.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_197.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_13.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_19.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_23.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1141.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_258.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_189.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_28.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_49.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_130.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_202.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1174.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1147.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_27.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_136.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_25.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_29.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_44.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_229.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_266.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1140.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_26.html
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1133.html
Machine-readable
- data.jsonThe whole dataset — every record with its source URL and source quote. Too big for one file at Cloudflare's 25 MB limit, so it is served in 2 numbered parts and this URL lists them.
- Open Knowledge Format bundleOne JSON object per line — every record's frontmatter and quoted span exactly as it is held here, in one fetch. Too big for one file at Cloudflare's 25 MB limit, so it is served in 4 numbered parts and this URL lists them.
- changes.xmlAtom feed of what changed and when — poll this instead of re-fetching the dataset. Also as changes.json.
- What changedThe same change history as a readable page — each date, what moved, and the records' current state.
- How this is made and checkedWhat "verified against source" does and does not mean.
From your own code
Same records, same quotes, without scraping the page: refsource is on PyPI and npm. Each value comes back carrying the URL it was read from and the sentence on that page that states it — .source and .quote sit on the value itself rather than in a side channel, so the checking step is available instead of skipped.
pip install refsource
refsource lookup fda-import-alert-red-list firm_name="Afghan Attaran Food & Beverage Company"
npx -y refsource lookup fda-import-alert-red-list firm_name="Afghan Attaran Food & Beverage Company"Set your AI assistant up to use this
Two files and no account. Put this in .mcp.json at the root of your project — Claude Code, Cursor, Windsurf, VS Code and Codex all read that file — and your assistant can look this register up instead of recalling it. The server is remote, keyless and read-only.
{
"mcpServers": {
"referencesource-import-alerts": {
"type": "http",
"url": "https://referencesource.org/mcp/import-alerts"
}
}
}Add to Cursor · or, on the command line: claude mcp add --transport http referencesource-import-alerts https://referencesource.org/mcp/import-alerts --scope project
Then one line in the project's CLAUDE.md or AGENTS.md, so the assistant knows when to reach for it:
When a question needs "FDA import alert red lists: firms subject to detention without physical examination", call the referencesource-import-alerts MCP server at https://referencesource.org/mcp/import-alerts (tool `resolve_firm`, dataset_slug `fda-import-alert-red-list`) instead of answering from memory — every record it returns carries its source URL and a verbatim quote from that page.What each tool does, and the servers built over single registers: Connect your AI assistant.