# Sangleaf Pharm., Co Ltd · 66-79 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 4 Sagimakgollo62beon-Gil; Jungwon , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 03/30/2023 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** All Drug and Drug Products _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_

## 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.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1174.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).