Reference Source

S ONE Pharmaceutical Inc. · 66-79 · KOREA (THE REPUBLIC OF)

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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

Source

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