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597253

SCL Health Front Range Inc. — FEI 1770152

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 1, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Wheat Ridge, CO (United States)

Facility

Other inspections at this facility

  • 1201258 (NAI Tue Mar 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067765 (NAI Wed Aug 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967054 (VAI Tue Jan 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870525 (NAI Wed Mar 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 814022 (VAI Mon Jan 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220221 CFR 606.170(a)Adverse Reaction - Investigations
135821 CFR 211.100(b)SOPs not followed / documented
6521 CFR 606.65(c)Testing of representative samples of reagent lots