FDA Inspection 728225 — Huvepharma Inc.
The FDA completed an inspection of Huvepharma Inc. on June 16, 2011 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). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |