FDA Inspection 907137 — 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 4, 2014 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 4, 2014
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sacramento, CA (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report