FDA Inspection
Wockhardt LimitedWockhardt Limited – FDA Inspection, Mar 17, 2015
Record Details
This FDA Inspection record concerns Wockhardt Limited, with an inspection on March 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wockhardt Limited
- Inspection Date
- March 17, 2015
- Product Type
- Drugs
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ID · 7869cbd3-0a7d-4313-b23d-2ba16b431a3e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 921885
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
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Other FDA inspections of Wockhardt Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | Office of Inspections and Investigations | |
| June 12, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 12, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 31, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Wockhardt Limited
- FDA Inspection 1319878 - 2026-04-24
- FDA Inspection 1097975 - 2019-06-12
- FDA Inspection 1089444 - 2019-04-12
- FDA Inspection 844314 - 2013-07-31
- FDA Inspection 703178 - 2010-12-17
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