FDA Inspection 1177370 — Fougera Pharmaceuticals Inc.
The FDA completed an inspection of Fougera Pharmaceuticals Inc. on August 10, 2022 in Melville, 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: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2022
- Fiscal Year
- 2022
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |