FDA Inspection 789270 — BioReliance Corporation
The FDA completed an inspection of BioReliance Corporation on July 3, 2012 in Rockville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 3, 2012
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4409 | 21 CFR 211.194(a)(4) | Data secured in course of each test |