Wockhardt Limited — FDA Facility Profile
Wockhardt Limited is an FDA-inspected facility (FEI 3002808503) located in Aurangabad, IN. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jun 12, 2019: No Action Indicated (NAI)
- Inspections on record
- 5 (2 OAI, 3 NAI)
- Last OAI inspection
- Mar 17, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 25, 2013
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 12, 2019 | No Action Indicated (NAI) | No citations listed |
| Apr 12, 2019 | No Action Indicated (NAI) | No citations listed |
| Mar 17, 2015 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training , Education , Experience overall (21 CFR 211.25(a)) Inadequate number of personnel (21 CFR 211.25(c)) Extent of discrepancy, failure investigations (21 CFR 211.192) and 7 more |
| Jul 31, 2013 | Official Action Indicated (OAI) | No citations listed |
| Dec 17, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Wockhardt Limited
- Location
- Aurangabad (IN)
- Source
- inspections