549816
Safetec Of America, Inc. — FEI 1000159898
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 25, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |