FDA inspection
Patheon Italia S.p.A.: FDA inspection ending Feb 10, 2026
FDA inspection 1304236 · Voluntary Action Indicated (VAI) · Monza
Key facts
| Inspection ID | 1304236 |
|---|---|
| Firm | Patheon Italia S.p.A. |
| FEI number | 3003065803 |
| Address | Viale Gian Battista Stucchi 110 |
| City | Monza |
| Country | Italy |
| Fiscal year | 2026 |
| Inspection end date | Feb 10, 2026 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data