FDA Inspection 1233111 — Amorepacific Corporation
The FDA completed an inspection of Amorepacific Corporation on March 16, 2024 in Osan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Osan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |