780778

Vitalant — FEI 2973165

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 7, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
San Francisco, CA (United States)

Citations

IDCFRDescription
21721 CFR 640.3(c)(1)History of viral hepatitis
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations