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613005

South Bend Medical Foundation, Inc. — FEI 1870308

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
South Bend, IN (United States)

Facility

Other inspections at this facility

  • 1277147 (VAI Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216966 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099142 (VAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013362 (VAI Fri May 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924611 (NAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations