# S ONE Pharmaceutical Inc. · 66-79 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For S ONE Pharmaceutical Inc. · 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 | All Drug and Drug Products; product code is 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 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 10/13/2022; address is 1073 Jeonyeong-Ro , Changsu-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** S ONE Pharmaceutical Inc. _(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:** 1073 Jeonyeong-Ro , Changsu-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/13/2022 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 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:** For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | ll Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing | All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing _(verified: each item appears in the quote below)_

## What the source says

> S ONE Pharmaceutical Inc. Date Published : 10/13/2022 1073 Jeonyeong-Ro , Changsu-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF) 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 07/12/2022 Desc: All Drug and Drug Products Notes: For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 07/12/2022 Desc: All Drug and Drug Products Notes: For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 56 - - - -- Antibiotics (Human/Animal) Date Published: 04/12/2024 Notes: ll Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 60 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 61 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 62 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 63 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 64 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 65 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug products are subject to DWPE under this listing 66 - - - -- Human and Animal Drugs Date Published: 07/12/2022 Notes: All Drug and Drug Products For product codes 53L--01 and 53L--06, only products found to be drug 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/).