FDA Inspection 781219 — The American National Red Cross South Carolina Region

The American National Red Cross South Carolina Region — FEI 1073009

The FDA completed an inspection of The American National Red Cross South Carolina Region on May 11, 2012 in Columbia, SC. 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
May 11, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Columbia, SC (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8521 CFR 606.100(b)(6)Methods of component preparation