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991589

Children's Hospital Colorado — FEI 1771443

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 11, 2016
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 1274639 (NAI Fri Jun 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095304 (NAI Fri Jun 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1094002 (NAI Fri May 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833281 (VAI Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 780127 (OAI Tue May 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
1811921 CFR 630.30(b)(2)Unsuitable donation - defer testing
1813421 CFR 640.21(g)Informed consent
27221 CFR 640.34(b)Fresh Frozen Plasma - storage requirements
6721 CFR 606.65(e)Following manufacturer's instructions
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations