Home / Inspections / 955076

955076

Elekta Inc — FEI 1937649

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 16, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Saint Charles, MO (United States)

Facility

Other inspections at this facility

  • 1190646 (NAI Fri Sep 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003704 (VAI Fri Feb 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730299 (VAI Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 665312 (NAI Fri May 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
367721 CFR 820.30(g)Design validation - software validation not performed
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate