FDA Inspection
Amneal Pharmaceuticals Inc.Amneal Pharmaceuticals Inc. – FDA Inspection, Jul 3, 2013
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Inc., with an inspection on July 3, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amneal Pharmaceuticals Inc.
- Inspection Date
- July 3, 2013
- Product Type
- Drugs
View Company Profile
ID · 9b57e6a3-1144-491a-ac3e-0feb77f99eae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840485
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Amneal Pharmaceuticals Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | New York District Office | |
| August 28, 2026 | Not classified | New York District Office | |
| June 7, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amneal Pharmaceuticals Inc.
- FDA Inspection 1305048 - 2026-09-25
- FDA Inspection 1286562 - 2026-08-28
- FDA Inspection 1207398 - 2023-06-07
- FDA Inspection 1116040 - 2019-12-20
- FDA Inspection 1089916 - 2019-04-18
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