FDA Inspection
Amneal Pharmaceuticals Inc.Amneal Pharmaceuticals Inc. – FDA Inspection, May 24, 2017
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Inc., with an inspection on May 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jay T. Wong (Issuing Officer)
- Rachael A. Moss (Issuing Officer)
View Company Profile
ID · ec7c89bd-a32e-46a9-a1f2-ea680bc248d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021115
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Full citation text and observation details available on the Dashboard.
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.