FDA Inspection
Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals, LLC – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, LLC, with an inspection on July 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 721cd88a-2bd4-48bc-98ab-fe97429abb9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022113
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
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 | |
| February 21, 2019 | 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 1083890 - 2019-02-21
- FDA Inspection 945542 - 2015-10-16
- FDA Inspection 851794 - 2013-10-17
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