FDA Inspection
Amneal Pharmaceuticals Pvt. Ltd.Amneal Pharmaceuticals Pvt. Ltd. – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Pvt. Ltd., with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2f81de63-f40f-483a-a0f8-fda69bffb484
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091111
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.28(b)Habits of good sanitation & health
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Other FDA inspections of Amneal Pharmaceuticals Pvt. Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 22, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals Pvt. Ltd.
- FDA Inspection 1216256 - 2023-07-14
- FDA Inspection 1121776 - 2020-02-21
- FDA Inspection 1067930 - 2018-08-24
- FDA Inspection 1031432 - 2017-09-22
- FDA Inspection 1011379 - 2017-04-12
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