FDA Inspection
Amneal Pharmaceuticals of New York, LLCAmneal Pharmaceuticals of New York, LLC – FDA Inspection, Apr 11, 2017
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals of New York, LLC, with an inspection on April 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9e0591cc-59f3-4b6d-8fae-82e2f368c387
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007417
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.28(a)Clothing appropriate for duties performed
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Other FDA inspections of Amneal Pharmaceuticals of New York, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2016 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amneal Pharmaceuticals of New York, LLC
- FDA Inspection 1118990 - 2020-02-03
- FDA Inspection 1082937 - 2019-03-18
- FDA Inspection 982074 - 2016-08-09
- FDA Inspection 918318 - 2015-03-16
- FDA Inspection 865012 - 2014-02-07
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