FDA Inspection 648046 — The American National Red Cross

The American National Red Cross — FEI 1076536

The FDA completed an inspection of The American National Red Cross on February 9, 2010 in Columbus, GA. 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
February 9, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Columbus, GA (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
20821 CFR 640.3(a)(1)Donor suitability procedures not followed