FDA Inspection 839378 — Patheon Italia S.P.A.
The FDA completed an inspection of Patheon Italia S.P.A. on Jun 11, 2013 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monza (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |