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773542

DonorConnect — FEI 3000215350

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Murray, UT (United States)

Facility

Other inspections at this facility

  • 1282450 (NAI Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100689 (VAI Tue Aug 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980883 (NAI Wed Jun 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823576 (NAI Thu Mar 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 622838 (NAI Mon Oct 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1229121 CFR 1271.80(d)(2)Plasma diluted test specimens
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1234021 CFR 1271.180(d)Adopted from another organization
1235921 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
1238421 CFR 1271.215Potential problems with recovery
1247221 CFR 1271.350(b)(1)Deviations not investigated