FDA Inspection 756528 — The American National Red Cross

The American National Red Cross — FEI 1276528

The FDA completed an inspection of The American National Red Cross on December 2, 2011 in Worcester, MA. 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
December 2, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Worcester, MA (United States)

Citations

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