FDA Inspection
Zydus Pharmaceuticals (USA) IncZydus Pharmaceuticals (USA) Inc – FDA Inspection, Feb 22, 2011
Record Details
This FDA Inspection record concerns Zydus Pharmaceuticals (USA) Inc, with an inspection on February 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 22, 2011
- Product Type
- Drugs
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ID · 3aac3a7b-5960-4024-ada0-b83449bfd69b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710971
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(b)Failure to review ADE information
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zydus Pharmaceuticals (USA) Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 15, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 14, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zydus Pharmaceuticals (USA) Inc
- FDA Inspection 1122499 - 2020-02-27
- FDA Inspection 878016 - 2014-05-15
- FDA Inspection 666881 - 2010-06-14
- FDA Inspection 605085 - 2009-08-11
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