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550334

GE OEC Medical Systems, Inc — FEI 1720753

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 21, 2008
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1217708 (NAI Thu Aug 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1145789 (NAI Tue Jun 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056985 (NAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920992 (OAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 747277 (NAI Wed Sep 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
317121 CFR 820.198(b)Rationale documented for no investigation
332521 CFR 820.180Storage
368921 CFR 820.100(a)(2)Investigation
369021 CFR 820.100(a)(3)Identification of actions needed
369221 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
64821 CFR 803.18(e)MDR not evaluated per 820.198