908575
Virbac Corporation — FEI 1944921
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 30, 2014
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bridgeton, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |
| 8914 | 21 CFR 314.81(b)(2)(iv)(b) | Mfg and control changes not requiring a supplemental app. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |