FDA Inspection 1021115 — Amneal Pharmaceuticals of New York, LLC
The FDA completed an inspection of Amneal Pharmaceuticals of New York, LLC on May 24, 2017 in Brookhaven, NY. 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
- May 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brookhaven, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |