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1145034

Medtronic Navigation, Inc. — FEI 1000517638

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 29, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Lafayette, CO (United States)

Facility

Other inspections at this facility

  • 1231178 (VAI Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103549 (VAI Mon Sep 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985377 (NAI Thu Aug 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910589 (NAI Mon Dec 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868471 (VAI Wed Feb 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate