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905464

Corewell Health Dearborn Hospital — FEI 1872469

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 2, 2014
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Dearborn, MI (United States)

Facility

Other inspections at this facility

  • 1204895 (NAI Thu Apr 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061643 (NAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 981522 (NAI Thu Jul 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 806974 (NAI Fri Oct 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 702515 (NAI Mon Dec 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
6521 CFR 606.65(c)Testing of representative samples of reagent lots
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs