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849871

GE Medical Systems Information Technologies, Inc. — FEI 2124823

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 25, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Milwaukee, WI (United States)

Facility

Other inspections at this facility

  • 1059359 (VAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802525 (VAI Tue Oct 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 679075 (NAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
313021 CFR 820.100(a)Lack of or inadequate procedures
337521 CFR 820.198(e)Records of complaint investigation
340921 CFR 820.200(d)Service reports
420721 CFR 806.10(d)Notification of extended action