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618906

CSL Plasma Inc. — FEI 3005484053

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 6, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Decatur, IL (United States)

Facility

Other inspections at this facility

  • 1112107 (VAI Fri Dec 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023159 (NAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944102 (NAI Wed Sep 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773874 (VAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
3121 CFR 606.20(b)Qualifications of responsible personnel
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