FDA Inspection
Amneal Complex Products Research LLCAmneal Complex Products Research LLC – FDA Inspection, Apr 18, 2018
Record Details
This FDA Inspection record concerns Amneal Complex Products Research LLC, with an inspection on April 18, 2018, issued by the New Jersey District Office, covering human drugs.
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ID · 173f9152-1f93-4e93-a9e5-fc6b7a77778c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048628
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Amneal Complex Products Research LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2025 | Not classified | New Jersey District Office | |
| May 17, 2024 | VAI | New Jersey District Office | New Drug Evaluation |
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 31, 2017 | Not classified | New Jersey District Office | |
| February 23, 2017 | Not classified | New Jersey District Office |
Other documents for Amneal Complex Products Research LLC
- FDA Inspection 1270546 - 2025-05-08
- FDA Inspection 1229038 - 2024-05-17
- FDA Inspection 1120970 - 2020-02-07
- FDA Inspection 1028824 - 2017-08-31
- FDA Inspection 1001323 - 2017-02-23
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