FDA Inspection
Amneal Pharmaceuticals Private Ltd.Amneal Pharmaceuticals Private Ltd. – FDA Inspection, Sep 19, 2026
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Private Ltd., with an inspection on September 19, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 01857ddf-aa2d-478c-a378-6a04a5d5dab7
Inspection Facts
- Inspection number
- 1328090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Amneal Pharmaceuticals Private Ltd.
6| 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 |
| July 19, 2019 | VAI | 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 |
Other documents for Amneal Pharmaceuticals Private Ltd.
- FDA Inspection 1245600 - 2024-07-19
- FDA Inspection 1210647 - 2023-06-09
- FDA Inspection 1100509 - 2019-07-19
- FDA Inspection 1056320 - 2018-05-03
- FDA Inspection 1034523 - 2017-11-10
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