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634606

CSL Plasma Inc. — FEI 3005601555

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Melrose Park, IL (United States)

Facility

Other inspections at this facility

  • 1232706 (NAI Thu Mar 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071041 (NAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985193 (NAI Tue Jun 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898360 (NAI Fri Sep 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
34321 CFR 640.65(b)(3)Donor identification system
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations