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675977

Evanston Hospital Blood Bank — FEI 1473456

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 13, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Evanston, IL (United States)

Facility

Other inspections at this facility

  • 1249555 (NAI Wed Sep 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098763 (VAI Tue Aug 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016698 (NAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017838 (NAI Mon Feb 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867919 (NAI Fri Feb 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220221 CFR 606.170(a)Adverse Reaction - Investigations
1233221 CFR 1271.170(b)Qualifications lacking
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