FDA Inspection 663872 — Amneal Pharmaceuticals, Llc
The FDA completed an inspection of Amneal Pharmaceuticals, Llc on May 26, 2010 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |