FDA Inspection 573486 — Bayer Healthcare Animal Health Inc
The FDA completed an inspection of Bayer Healthcare Animal Health Inc on Apr 21, 2009 in Saint Joseph, MO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 21, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Joseph, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3586 | 21 CFR 211.110(a)(1) | Tablet or capsule weight variation |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |