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588676

Octapharma Plasma Inc — FEI 3006468609

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 29, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Wichita, KS (United States)

Facility

Other inspections at this facility

  • 1153683 (NAI Thu Sep 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008990 (NAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916482 (NAI Thu Mar 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 757171 (NAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 649786 (NAI Wed Mar 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
324821 CFR 640.63(a)Determining donor suitability
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
904421 CFR 600.10(b)Personnel capabilities
931721 CFR 640.65(b)(8)Timing