FDA Inspection 1281564 — Patheon Pharmaceuticals Inc.
The FDA completed an inspection of Patheon Pharmaceuticals Inc. on Sep 26, 2025 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |