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654608

Sanford Medical Center — FEI 1771187

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 26, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Sioux Falls, SD (United States)

Facility

Other inspections at this facility

  • 1223377 (NAI Fri Oct 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067120 (NAI Thu Sep 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926726 (NAI Tue Mar 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838004 (NAI Thu Jun 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727315 (NAI Tue May 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
22421 CFR 640.4(f)Arm preparation
24721 CFR 640.24(b)Storage until removal of platelets
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs