753196

UNM Hospitals — FEI 1000517650

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 13, 2011
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Albuquerque, NM (United States)

Citations

IDCFRDescription
11721 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
127021 CFR 211.68(b)input/output verification
441321 CFR 211.194(a)(8)Second person sign off
5721 CFR 606.60(a)Maintain and clean equipment
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs