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1250468

Rocky Mountain Lions Eye Bank — FEI 1000517466

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Aurora, CO (United States)

Facility

Other inspections at this facility

  • 1057040 (NAI Thu Apr 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951842 (VAI Fri Aug 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769336 (VAI Thu Feb 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 676302 (NAI Thu Aug 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 563285 (VAI Tue Feb 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1222221 CFR 1271.47(a)Design of procedures to ensure compliance
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228221 CFR 1271.75(d)Donors with risks not determined ineligible
1232221 CFR 1271.160(b)(4)Training of personnel