Home / Inspections / 673560

673560

Avera McKennan Hospital & University Health Center — FEI 1772097

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 1, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sioux Falls, SD (United States)

Facility

Other inspections at this facility

  • 1223896 (NAI Wed Oct 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068082 (NAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986752 (NAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897538 (NAI Fri Oct 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799281 (NAI Tue Sep 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
923421 CFR 630.40(c)Notification w/in 8 weeks