FDA Inspection 1079307 — Lupin Limited
The FDA completed an inspection of Lupin Limited on January 25, 2019 in Pithampur. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 25, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pithampur (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |