FDA Inspection 1275680 — Lupin Limited
The FDA completed an inspection of Lupin Limited on Jul 17, 2025 in Pithampur. 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 17, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pithampur (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |