FDA Inspection 810452 — University of California, Davis Med Center Blood Bank

University of California, Davis Med Center Blood Bank — FEI 2972222

The FDA completed an inspection of University of California, Davis Med Center Blood Bank on December 12, 2012 in Sacramento, 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 12, 2012
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sacramento, CA (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs