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570531

Sterigenics US, LLC — FEI 1450293

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 18, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Compliance: Devices
Location
Willowbrook, IL (United States)

Facility

Other inspections at this facility

  • 1017915 (NAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013355 (VAI Fri Apr 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913117 (NAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809586 (NAI Mon Nov 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 745140 (NAI Fri Oct 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
169721 CFR 110.80(b)(4)Preventive control measures
322521 CFR 820.70(g)(3)Adjustment
322721 CFR 820.70(g)(1)Activity documentation
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures