FDA Inspection 1210950 — Aurobindo Pharma Ltd
The FDA completed an inspection of Aurobindo Pharma Ltd on Jul 21, 2023 in Medchal. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medchal (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |