FDA Inspection
Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals, LLC – FDA Inspection, Feb 21, 2019
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, LLC, with an inspection on February 21, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · af007638-d569-4978-98ed-71a39f7f5009
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083890
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Amneal Pharmaceuticals, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2023 | NAI | Compliance: Devices | |
| July 27, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals, LLC
- FDA Inspection 1229037 - 2024-02-08
- FDA Inspection 1223892 - 2023-08-21
- FDA Inspection 1022113 - 2017-07-27
- FDA Inspection 945542 - 2015-10-16
- FDA Inspection 851794 - 2013-10-17
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