FDA Inspection 854082 — Amneal Pharmaceuticals, Llc
The FDA completed an inspection of Amneal Pharmaceuticals, Llc on November 13, 2013 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |