FDA Inspection 649435 — American National Red Cross (The), Lewis and Clark Region

American National Red Cross (The), Lewis and Clark Region — FEI 3001451955

The FDA completed an inspection of American National Red Cross (The), Lewis and Clark Region on March 23, 2010 in Murray, UT. 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
March 23, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Murray, UT (United States)

Citations

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