FDA Inspection 1254771 — Alembic Pharmaceuticals Limited
The FDA completed an inspection of Alembic Pharmaceuticals Limited on Nov 22, 2024 in Vadodara. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vadodara (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |