FDA Inspection 1201100 — Alembic Pharmaceuticals Limited
The FDA completed an inspection of Alembic Pharmaceuticals Limited on Mar 24, 2023 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 24, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vadodara (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |