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794613

KEDPlasma LLC — FEI 1720702

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 8, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Lincoln, NE (United States)

Facility

Other inspections at this facility

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  • 1153598 (NAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032157 (NAI Thu Oct 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 955258 (NAI Fri Jan 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 879571 (NAI Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
324621 CFR 640.61Obtaining consent in an appropriate manner
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations