FDA Inspection
Amneal Pharmaceuticals, LlcAmneal Pharmaceuticals, Llc – FDA Inspection, Nov 13, 2013
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, Llc, with an inspection on November 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amneal Pharmaceuticals, Llc
- Inspection Date
- November 13, 2013
- Product Type
- Drugs
View Company Profile
ID · 89510723-8236-4dbc-961e-e31fa50956ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854082
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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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 |
| February 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2010 | VAI | 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 767064 - 2012-02-10
- FDA Inspection 663872 - 2010-05-26
- FDA Inspection 545906 - 2008-11-10
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