FDA Inspection 1033982 — Cipla Limited
The FDA completed an inspection of Cipla Limited on December 6, 2017 in Raigad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 6, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Raigad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2025 | 21 CFR 211.188(b)(13) | Results of drug product inspections and examinations |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |