FDA Inspection 1215187 — Vetio Animal Health ULC
The FDA completed an inspection of Vetio Animal Health ULC on August 18, 2023 in Saint-Laurent. 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
- August 18, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint-Laurent (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |