Reference Source

Sangleaf Pharm., Co Ltd · 66-79 · KOREA (THE REPUBLIC OF)

For Sangleaf Pharm., Co Ltd · 66-79 · KOREA (THE REPUBLIC OF), import alert is 66-79; import alert name is "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"; country is KOREA (THE REPUBLIC OF); product is All Drug and Drug Products; product code is 53 I - - -- Oral Hygiene Prod | 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; date published is 03/30/2023; address is 4 Sagimakgollo62beon-Gil; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

Firm
Sangleaf Pharm., Co Ltd verified
Import alert
66-79
Import alert name
"Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
Country
KOREA (THE REPUBLIC OF) verified
Address
4 Sagimakgollo62beon-Gil; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
Date published
03/30/2023 verified
Product code
53 I - - -- Oral Hygiene Prod | 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 each item verified
Product
All Drug and Drug Products verified
FDA notes
For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. | All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 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

Sangleaf Pharm., Co Ltd Date Published : 03/30/2023 4 Sagimakgollo62beon-Gil; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) 53 I - - -- Oral Hygiene Prod Date Published: 03/30/2023 Desc: All Drug and Drug Products Notes: For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 56 - - - -- Antibiotics (Human/Animal) Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 60 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 61 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 62 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 63 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 64 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 65 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing. 66 - - - -- Human and Animal Drugs Date Published: 03/30/2023 Notes: All Drug and Drug Products; For product code 53I[][][], only fluoride containing toothpaste products are subject to DWPE under this listing.

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

Source

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