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1063873

Indiana University Health — FEI 1876269

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Indianapolis, IN (United States)

Facility

Other inspections at this facility

  • 1249543 (NAI Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092644 (NAI Wed Jun 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985018 (NAI Thu Sep 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884534 (VAI Mon Jun 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799161 (VAI Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15021 CFR 606.151(e)Procedures to maintain records of emergency transfusions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report