Wockhardt Limited — FDA Facility Profile
Wockhardt Limited is an FDA-inspected facility (FEI 3005289335) located in Aurangabad, IN. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 26, 2015: Official Action Indicated (OAI)
- Inspections on record
- 4 (2 OAI, 2 VAI)
- Last OAI inspection
- May 26, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Jul 18, 2013
- Recalls as the recalling firm
- 1, latest Jun 19, 2018
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 26, 2015 | Official Action Indicated (OAI) | No citations listed |
| Mar 22, 2013 | Official Action Indicated (OAI) | No citations listed |
| Jan 27, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 30, 2009 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 19, 2018 | Class III | D-0912-2018 | Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container… and 1 more product Failed Impurities/Degradation Specifications |
Facility details
- Company
- Wockhardt Limited
- Location
- Aurangabad (IN)
- Source
- inspections