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667872

Eastern Colorado Health Care System — FEI 1770147

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 10, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 1232796 (NAI Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083599 (NAI Thu Feb 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019116 (NAI Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920079 (VAI Mon Mar 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 813939 (VAI Mon Jan 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8921 CFR 606.100(b)(10)Controlling storage temperatures