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883409

North Colorado Medical Center Blood Bank — FEI 1774110

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 20, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Greeley, CO (United States)

Facility

Other inspections at this facility

  • 1172087 (NAI Tue Jun 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057280 (NAI Thu May 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982328 (NAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 771157 (VAI Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 650590 (VAI Wed Feb 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
16221 CFR 606.165(a)Distribution and receipt - recalls
202621 CFR 211.192Quality control unit review of records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations