FDA Inspection 857953 — Fougera Pharmaceuticals, LLC.
The FDA completed an inspection of Fougera Pharmaceuticals, LLC. on December 20, 2013 in Hicksville, NY. 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Hicksville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |