FDA Inspection 535897 — University of California, Davis IRB

University of California, Davis IRB — FEI 3000310173

The FDA completed an inspection of University of California, Davis IRB on November 4, 2008 in Davis, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Davis, CA (United States)

Additional Details

IRB

Citations

IDCFRDescription
733521 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)