FDA Inspection
Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals, LLC – FDA Inspection, Apr 6, 2018
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, LLC, with an inspection on April 6, 2018, issued by the New Jersey District Office, covering human drugs.
- People
- Amy M. Cramer (Issuing Officer)
- Yvesna C. Blaise (Issuing Officer)
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ID · eb66987b-3a43-4b7a-8549-00b1f52cb138
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047538
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 820.20(c)Management review dates
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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Other FDA inspections of Amneal Pharmaceuticals, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2026 | Not classified | New Jersey District Office | |
| March 28, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 21, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amneal Pharmaceuticals, LLC
- FDA Inspection 1309420 - 2026-04-30
- FDA Inspection 1256805 - 2025-03-28
- FDA Inspection 1226102 - 2023-11-21
- FDA Inspection 1162045 - 2022-02-10
- FDA Inspection 1075997 - 2018-10-19
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