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745825

Vitalant — FEI 1671462

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 16, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
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
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
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