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1215298

Sterigenics U.S., LLC — FEI 2219920

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 15, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Rockaway, NJ (United States)

Facility

Other inspections at this facility

  • 1123488 (NAI Mon Mar 02 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081756 (NAI Wed Oct 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969813 (NAI Fri May 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810569 (NAI Fri Dec 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 629535 (NAI Fri Nov 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
323721 CFR 820.72(b)Remedial action
54621 CFR 820.75(a)Lack of or inadequate process validation