FDA Inspection 733170 — Bio-Rad Laboratories, Inc.

Bio-Rad Laboratories, Inc. — FEI 2915274

The FDA completed an inspection of Bio-Rad Laboratories, Inc. on July 8, 2011 in Hercules, 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 8, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Hercules, CA (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
419321 CFR 806.10(b)Time to report - 10 days