702415

ImpactLife — FEI 1970356

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 16, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Davenport, IA (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
926221 CFR 610.40(b)One or more approved screening tests