FDA Inspection 811101 — The American National Red Cross

The American National Red Cross — FEI 3072990

The FDA completed an inspection of The American National Red Cross on December 7, 2012 in Boise, ID. 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 7, 2012
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Boise, ID (United States)

Citations

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