FDA Inspection 914340 — American Red Cross Blood Services North Central Region

American Red Cross Blood Services North Central Region — FEI 2130199

The FDA completed an inspection of American Red Cross Blood Services North Central Region on February 13, 2015 in Eau Claire, WI. 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 13, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Eau Claire, WI (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs