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808877

Vitalant — FEI 1671462

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 30, 2012
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Albuquerque, NM (United States)

Facility

Other inspections at this facility

  • 1251496 (NAI Fri Aug 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118232 (NAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044582 (NAI Fri Dec 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980906 (NAI Thu Jun 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923869 (VAI Wed Apr 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
25521 CFR 640.31Donor eligibility
26021 CFR 640.31(b)Criteria for plasmapheresis donor eligibility
441321 CFR 211.194(a)(8)Second person sign off