FDA Inspection 697759 — Patheon Manufacturing Services LLC
The FDA completed an inspection of Patheon Manufacturing Services LLC on December 21, 2010 in Ridgefield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgefield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4394 | 21 CFR 211.186(b)(3) | Components complete listing |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |