FDA Inspection 1173870 — Kolmar Korea Co., Ltd.
The FDA completed an inspection of Kolmar Korea Co., Ltd. on Jul 7, 2022 in Sejong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 7, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sejong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |