FDA Inspection 1275446 — Lupin Limited
The FDA completed an inspection of Lupin Limited on Jul 17, 2025 in Pithampur. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 17, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pithampur (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |