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553295

Harper University Hospital — FEI 1872848

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2008
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Detroit, MI (United States)

Facility

Other inspections at this facility

  • 1181047 (NAI Wed Aug 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032401 (NAI Thu Nov 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 907759 (NAI Thu Dec 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805609 (NAI Fri Oct 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 700488 (VAI Mon Dec 06 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
3121 CFR 606.20(b)Qualifications of responsible personnel
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs