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816364

University Of Colorado Hospital Clinical Laboratory — FEI 3003233482

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 1247118 (NAI Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115615 (NAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061865 (NAI Fri Aug 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010569 (NAI Fri Mar 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906144 (NAI Mon Nov 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8921 CFR 606.100(b)(10)Controlling storage temperatures
9821 CFR 606.100(c)Thorough investigations