S ONE Pharmaceutical Inc. · 66-79 · KOREA (THE REPUBLIC OF)
For S ONE Pharmaceutical Inc., import alert is 66-79; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"; 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 2026-09-30.
- Firm
- S ONE Pharmaceutical Inc. 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
- 1073 Jeonyeong-Ro , Changsu-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 10/13/2022 verified
- 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 each item verified
- Product
- All Drug and Drug Products | All Drug and Drug Products each item verified
- 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 each item verified
What the source says
S ONE Pharmaceutical Inc. Date Published : 10/13/2022 1073 Jeonyeong-Ro , Changsu-Myeon , Pocheon, Gyeonggi KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1174.html