FDA Inspection 1056170 — Intas Pharmaceuticals Limited
The FDA completed an inspection of Intas Pharmaceuticals Limited on June 8, 2018 in Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |