FDA Inspection 906620 — Bayer Healthcare Animal Health Inc
The FDA completed an inspection of Bayer Healthcare Animal Health Inc on Dec 29, 2014 in Saint Joseph, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 29, 2014
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saint Joseph, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |