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854496

Vitalant — FEI 3000210247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Denver, CO (United States)

Facility

Other inspections at this facility

  • 1260274 (VAI Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106655 (NAI Tue Sep 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023598 (VAI Thu Aug 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983419 (NAI Tue Oct 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900184 (NAI Tue Oct 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
20821 CFR 640.3(a)(1)Donor suitability procedures not followed
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations