FDA Inspection 1230224 — Kolmar Korea Co., Ltd. - Gwanjeong Factory
The FDA completed an inspection of Kolmar Korea Co., Ltd. - Gwanjeong Factory on February 16, 2024 in Chungcheongnam-Do. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chungcheongnam-Do (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |