FDA Inspection 841054 — Patheon Italia S.P.A
The FDA completed an inspection of Patheon Italia S.P.A on Jun 21, 2013 in Ferentino. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ferentino (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |