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909240

Octapharma Plasma Inc — FEI 3006604254

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 8, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Omaha, NE (United States)

Facility

Other inspections at this facility

  • 1153219 (NAI Tue Sep 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009884 (NAI Fri Mar 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820739 (NAI Wed Feb 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732180 (VAI Tue Jun 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 608945 (NAI Fri Aug 28 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
904421 CFR 600.10(b)Personnel capabilities