FDA Inspection 1083890 — Amneal Pharmaceuticals, LLC
The FDA completed an inspection of Amneal Pharmaceuticals, LLC on February 21, 2019 in Branchburg, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Branchburg, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |