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858681

Aurora St. Luke's Medical Center — FEI 1000389954

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 9, 2013
Fiscal Year
2014
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
15021 CFR 606.151(e)Procedures to maintain records of emergency transfusions
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
6721 CFR 606.65(e)Following manufacturer's instructions
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations