FDA Inspection 1304236 — Patheon Italia S.P.A.
The FDA completed an inspection of Patheon Italia S.P.A. on Feb 10, 2026 in Monza. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Monza (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |