FDA Inspection
Amneal Pharmaceuticals Inc.Amneal Pharmaceuticals Inc. – FDA Inspection, Jun 7, 2023
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals Inc., with an inspection on June 7, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 3fb001b4-13cc-4af8-a29d-a22d346c90c1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1207398
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 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 | |
| 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 |
| January 30, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals Inc.
- FDA Inspection 1305048 - 2026-09-25
- FDA Inspection 1286562 - 2026-08-28
- FDA Inspection 1116040 - 2019-12-20
- FDA Inspection 1089916 - 2019-04-18
- FDA Inspection 1077700 - 2019-01-30
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.