FDA Inspection 1048097 — Alembic Pharmaceuticals Limited
The FDA completed an inspection of Alembic Pharmaceuticals Limited on March 20, 2018 in Panchmahal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Panchmahal (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |