FDA Inspection 921885 — Wockhardt Limited
The FDA completed an inspection of Wockhardt Limited on March 17, 2015 in Aurangabad. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurangabad (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 |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |