FDA Inspection 1002848 — Centaur Pharmaceuticals Private Ltd.
The FDA completed an inspection of Centaur Pharmaceuticals Private Ltd. on Nov 14, 2016 in Pune. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 14, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pune (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1912 | 21 CFR 211.166(a) | Written program not followed |