FDA Inspection 819572 — Huvepharma Inc.
The FDA completed an inspection of Huvepharma Inc. on February 28, 2013 in Saint Louis, MO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 28, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2245 | 21 CFR 226.20(b) | Lighting, ventilation, screening, dust, temperature |
| 2353 | 21 CFR 226.58(b) | Specifications, test procedures - Type A medicated articles |
| 2375 | 21 CFR 226.40(b) | Container receipt, identification, storage, and handling |
| 2378 | 21 CFR 226.40(d) | Distribution despite discrepancies in yield |
| 4159 | 21 CFR 226.58(d) | Components uniformly dispersed and stable |