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627148

Aurora St. Luke's Medical Center — FEI 1000389954

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 8, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Milwaukee, WI (United States)

Facility

Other inspections at this facility

  • 1273767 (VAI Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175053 (NAI Thu Jun 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053336 (NAI Wed Apr 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 962748 (VAI Wed Mar 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946191 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
6721 CFR 606.65(e)Following manufacturer's instructions
9821 CFR 606.100(c)Thorough investigations