James A Lane - FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Bothell WA 98021

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOIII MDRHIB

Overview Statistics

152
Total Inspections
40
Total 483s Issued
2
Warning Letters Issued

Inspection Details

Longest Inspection: 22 days
Shortest Inspection: 1 days
Average Length: 2.5 days

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James A Lane's Recent Inspections

DateCompanyCityCountryFEI Number483
2020-10-15KESTRA MEDICAL TECHNOLOGIESKirklandUnited States3015185344
2020-03-06Intuitive Surgical, Inc.SunnyvaleUnited States3001675293
2020-01-22Peter Lazic GmbhTuttlingenGermany3007264034
2020-01-16Lilly France S.A.S.FegersheimFrance3002807475
2020-01-06Gynex CorporationRedmondUnited States3001238683
2019-12-18Fluke Biomedical LLCEverettUnited States2921581
2019-11-26Physio-Control, Inc.RedmondUnited States3015876
2019-10-23Alpinion USA IncBothellUnited States3009293490
2019-09-25Paragon BioTeck, Inc.PortlandUnited States3009934432
2019-09-12Medicol USA IncorporatedLos GatosUnited States3005205318

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James A Lane - Co-Inspectors

NameInspectionsLast Inspection
Daniel J Gorski92011
Joseph R Strelnik82011
Eric J Heinze42020
Eric S Pittman42010
Sara M Richardson32017
Ryan J Benedict32010
Anthony R Petriella32010
Juanj Wu22019
Juanj N Wu22019
Yong Hu22018
Truong X Nguyen22018
Eric W Anderson22016
Joseph Tibay22016
Deborah K Richardson22016
Andrea D Swingle22012
Patrick B Cummings22011
Dawn C Olenjack22011
Ifueko Osemwota22011
Brandi N Mcgrady22011
Bernard P Heidt22010
Calvin K Cook22010
Amogh Pathi12020
Stephen R Souza12019
Chengjiu Hu12017
Rumany C Penn12017
Ashar P Parikh12017
Eileen A Liu12017
Emmanuel O Kerry12016
Lea Lakes12016
Andrew E Kay12016
Brian P Hendrickson12011
Joie A Navarrete12011
Constantin Y Philopoulos12011
Kimberly Y Martin12010
Larry K Austin12010

James A Lane's Active Locations

  • United States
  • Germany
  • France
  • China
  • United Kingdom
  • Switzerland
  • Ireland
  • Korea (the Republic of)
  • Sweden

James A Lane's Year-wise Inspection Count

  • 2009:4 inspections
  • 2010:26 inspections
  • 2011:32 inspections
  • 2012:11 inspections
  • 2016:18 inspections
  • 2017:25 inspections
  • 2018:13 inspections
  • 2019:18 inspections
  • 2020:5 inspections
Last Updated: 2025-05-14 06:11:22