FDA Inspection 1087819 — Huvepharma, Inc.
The FDA completed an inspection of Huvepharma, Inc. on April 23, 2019 in Longmont, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 23, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Longmont, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |