FDA Inspection 1232189 — Alembic Pharmaceuticals Limited
The FDA completed an inspection of Alembic Pharmaceuticals Limited on Mar 8, 2024 in Panchmahal. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Panchmahal (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |