FDA Inspection 992746 — Intas Pharmaceuticals Limited
The FDA completed an inspection of Intas Pharmaceuticals Limited on October 19, 2016 in Taluka Sanand, Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 19, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taluka Sanand, Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |