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1032396

Isomedix Operations Inc — FEI 1526711

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 30, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Groveport, OH (United States)

Facility

Other inspections at this facility

  • 1276319 (NAI Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177943 (VAI Mon Jul 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 899490 (NAI Fri Oct 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 794210 (VAI Thu Aug 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 644445 (VAI Wed Jan 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
54621 CFR 820.75(a)Lack of or inadequate process validation