Sharon I Gundersen - FDA Investigator Report

Overview Statistics

107
Total Inspections
53
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 130 days
Shortest Inspection: 1 days
Average Length: 6.7 days

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Sharon I Gundersen's Recent Inspections

DateCompanyCityCountryFEI Number483
2016-08-31Varian Medical Systems, Inc.SeattleUnited States3004837948
2016-08-22Breast Microseed IncMercer IslandUnited States3012692946
2016-07-27Natus Medical IncorporatedSeattleUnited States3018859
2016-04-21Ortho Kinetics CorpVistaUnited States1000160800
2016-04-20Diazyme LaboratoriesPowayUnited States3004445302
2016-04-15Acon Laboratories, Inc.San DiegoUnited States3003516723
2016-04-15Virginia Mason Medical CenterSeattleUnited States3001239271
2016-04-13XENCO MEDICAL LLCSan DiegoUnited States3011181154
2016-02-12Integrated Technologies, Ltd.AshfordUnited Kingdom3002809568
2016-02-10DySIS MedicalLivingstonUnited Kingdom3009142105

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Sharon I Gundersen - Co-Inspectors

NameInspectionsLast Inspection
Lori J Silverstein52013
Cynthia L Gorveatt42016
Stephen R Souza42016
Paul M Kawamoto22015
Graham N Giesen22012
Daniel A Congdon22011
Katherine L Arnold22011
Christopher S Genther12016
Scott W Fox12015
Christopher R Czajka12015
Xiaojun Yan12014
Marijo B Kambere12014
Heika R Tait12013
Anita Narula12013
Sangeeta M Khurana12013
Julia E Chervoni12013
Ashleigh P Barkans12012
Mark S Crippen12011
John W Banks12011
Dirk L Lincoln12011
Jonathan T Little12011
Hugh Grimoldby12011

Sharon I Gundersen's Active Locations

  • United States
  • Germany
  • United Kingdom
  • Netherlands
  • France
  • Austria
  • Finland

Sharon I Gundersen's Year-wise Inspection Count

  • 2011:30 inspections
  • 2012:16 inspections
  • 2013:16 inspections
  • 2014:20 inspections
  • 2015:13 inspections
  • 2016:12 inspections
Last Updated: 2025-05-14 06:11:22