FDA Inspection 731289 — Patheon Manufacturing Services LLC
The FDA completed an inspection of Patheon Manufacturing Services LLC on Jun 21, 2011 in Ridgefield, NJ. 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 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgefield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |