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785852

Barnes-Jewish Hospital Blood Bank — FEI 1974272

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 6, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Saint Louis, MO (United States)

Facility

Other inspections at this facility

  • 1240233 (NAI Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122248 (NAI Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049735 (NAI Thu Apr 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967700 (VAI Tue Apr 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865778 (VAI Thu Feb 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
904421 CFR 600.10(b)Personnel capabilities
9821 CFR 606.100(c)Thorough investigations