FDA Inspection
Amneal Pharmaceuticals Private Ltd.Amneal Pharmaceuticals Private Ltd. – FDA Inspection, Jul 19, 2019
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Private Ltd., with an inspection on July 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e143a82c-7104-4216-9c2f-4cc1caeed700
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100509
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Amneal Pharmaceuticals Private Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 9, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 3, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals Private Ltd.
- FDA Inspection 1245600 - 2024-07-19
- FDA Inspection 1210647 - 2023-06-09
- FDA Inspection 1056320 - 2018-05-03
- FDA Inspection 1034523 - 2017-11-10
- FDA Inspection 921533 - 2015-03-19
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