FDA Inspection 812889 — Hoxworth Blood Center University of Cincinnati

Hoxworth Blood Center University of Cincinnati — FEI 1000149727

The FDA completed an inspection of Hoxworth Blood Center University of Cincinnati on January 7, 2013 in Fort Mitchell, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 7, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Fort Mitchell, KY (United States)

Citations

IDCFRDescription
16121 CFR 606.160(a)(2)Determination of lot numbers and supplies
22421 CFR 640.4(f)Arm preparation
4121 CFR 606.40(a)(1)Provide space for examination