FDA Inspection 1013402 — Kim Chemicals Private Ltd.
The FDA completed an inspection of Kim Chemicals Private Ltd. on June 9, 2017 in Taloja, Raigad. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taloja, Raigad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |