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802525

GE Medical Systems Information Technologies, Inc. — FEI 2124823

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 9, 2012
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))
  • 849871 (VAI Wed Sep 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 679075 (NAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471721 CFR 820.30(g)Design validation - software validation documentation
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
419121 CFR 806.10(a)(1)Report of risk to health
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month