FDA Inspection 794241 — Bio-Rad Laboratories, Inc.
The FDA completed an inspection of Bio-Rad Laboratories, Inc. on July 26, 2012 in Benicia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Benicia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |