1067063
SV Labs Prescott Corporation — FEI 2130687
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Prescott, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |