FDA Inspection 992897 — Fougera Pharmaceuticals, LLC.
The FDA completed an inspection of Fougera Pharmaceuticals, LLC. on November 10, 2016 in Hicksville, NY. 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2016
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Hicksville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |