FDA Inspection
Amneal Pharmaceuticals, LlcAmneal Pharmaceuticals, Llc – FDA Inspection, May 26, 2010
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, Llc, with an inspection on May 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amneal Pharmaceuticals, Llc
- Inspection Date
- May 26, 2010
- Product Type
- Drugs
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ID · e50a0b9f-2563-407d-ac89-6dafc80e30eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663872
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Amneal Pharmaceuticals, Llc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals, Llc
- FDA Inspection 1029733 - 2017-10-25
- FDA Inspection 989412 - 2016-10-13
- FDA Inspection 854082 - 2013-11-13
- FDA Inspection 767064 - 2012-02-10
- FDA Inspection 545906 - 2008-11-10
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