Reference Source

Silvana Natalia Galvan Ponce De Leon · 99-39 · MEXICO

For Silvana Natalia Galvan Ponce De Leon · 99-39 · MEXICO, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is MEXICO; product is COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO | COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA | COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO; product code is 30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid; date published is 07/31/2019; address is Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO, verified against its source on 2026-09-16.

Firm
Silvana Natalia Galvan Ponce De Leon verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
MEXICO verified
Address
Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO verified
Date published
07/31/2019 verified
Product code
30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid each item verified
Product
COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO | COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA | COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO each item verified
FDA notes
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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. | 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(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. The ingredient statement fails to declare "sorbate" and "benzoate"; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The statement of identity, ingredients, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). | 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Silvana Natalia Galvan Ponce De Leon Date Published : 07/31/2019 Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO 30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors Date Published: 08/01/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO Notes: 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid Date Published: 07/31/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA Notes: 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(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. The ingredient statement fails to declare "sorbate" and "benzoate"; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The statement of identity, ingredients, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid Date Published: 08/01/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO Notes: 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling.

accessdata.fda.gov, retrieved 2026-09-15

Source

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