FDA Inspection 1148652 — Huvepharma Inc.
The FDA completed an inspection of Huvepharma Inc. on August 10, 2021 in Saint Louis, MO. 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, 2021
- Fiscal Year
- 2021
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |