# K.Boeun Pharmaceutical Co.,Ltd. · 66-40 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For K.Boeun Pharmaceutical Co.,Ltd. · 66-40 · KOREA (THE REPUBLIC OF), import alert is 66-40; import alert name is "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"; country is KOREA (THE REPUBLIC OF); product is All Drug and Drug Products | All Drug and Drug Products; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, 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; date published is 08/11/2023; address is 114 Jangjagyeongje-Ro , Sinbung-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** K.Boeun Pharmaceutical Co.,Ltd. _(verified: appears in the quote below)_
- **Import alert:** 66-40
- **Import alert name:** "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 114 Jangjagyeongje-Ro , Sinbung-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/11/2023 _(verified: appears in the quote below)_
- **Product code:** 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 53 I - - 99 Other Oral Hygiene Products, without Fluoride, 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 _(verified: each item appears in the quote below)_
- **Product:** All Drug and Drug Products | All Drug and Drug Products _(verified: each item appears in the quote below)_
- **FDA notes:** 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 _(verified: each item appears in the quote below)_

## What the source says

> K.Boeun Pharmaceutical Co.,Ltd. Date Published : 08/11/2023 114 Jangjagyeongje-Ro , Sinbung-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF) 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 08/11/2023 Desc: All Drug and Drug Products 53 I - - 99 Other Oral Hygiene Products, without Fluoride, N.E.C. Date Published: 08/11/2023 Desc: All Drug and Drug Products 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 08/11/2023 Notes: All Drug and Drug Products 56 - - - -- Antibiotics (Human/Animal) Date Published: 08/11/2023 Notes: All Drug and Drug Products 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 60 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 61 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 62 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 63 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 64 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 65 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products 66 - - - -- Human and Animal Drugs Date Published: 08/11/2023 Notes: All Drug and Drug Products

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_189.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/).