FDA Inspection 663080 — Patheon Puerto Rico Inc.
The FDA completed an inspection of Patheon Puerto Rico Inc. on May 4, 2010 in Caguas, PR. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |