FDA Inspection 810508 — Cosmax USA, Corporation
The FDA completed an inspection of Cosmax USA, Corporation on December 13, 2012 in Carteret, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 13, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carteret, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |