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842523

M Health Fairview University of Minnesota Medical Center, East Bank-Blood Bank — FEI 2170604

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 30, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Minneapolis, MN (United States)

Facility

Other inspections at this facility

  • 1251216 (NAI Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071058 (NAI Thu Oct 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001549 (NAI Wed Feb 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909076 (NAI Mon Dec 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 743550 (NAI Thu Aug 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220221 CFR 606.170(a)Adverse Reaction - Investigations
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs