FDA Inspection 1000409 — COSON Co., Ltd. _Osan Plant
The FDA completed an inspection of COSON Co., Ltd. _Osan Plant on Jan 19, 2017 in Osan. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Osan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |