1232189
Alembic Pharmaceuticals Limited — FEI 3014866088
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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 |