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1259647

Suncoast Communities Blood Bank, Inc. — FEI 1051993

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 31, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bradenton, FL (United States)

Facility

Other inspections at this facility

  • 1174873 (NAI Fri Jul 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049925 (NAI Fri Jan 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964139 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897635 (NAI Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776065 (VAI Thu Apr 05 2012 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
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations