FDA Inspection 785441 — Patheon Softgels Inc
The FDA completed an inspection of Patheon Softgels Inc on Jun 6, 2012 in High Point, NC. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 6, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- High Point, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |