FDA Inspection 915468 — The American National Red Cross

The American National Red Cross — FEI 3000210078

The FDA completed an inspection of The American National Red Cross on February 20, 2015 in Grand Island, NE. 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 20, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Grand Island, NE (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations