635815

Versiti Wisconsin Inc. - Transfusion Service — FEI 3002633012

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Wauwatosa, WI (United States)

Citations

IDCFRDescription
6121 CFR 606.60(a)Provide proper equipment to meet requirements
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations