FDA Inspection 1220064 — Patheon Italia S.P.A.
The FDA completed an inspection of Patheon Italia S.P.A. on Sep 29, 2023 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
- Sep 29, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Monza (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |