James R Montero - FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Salt Lake City UT 84116

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOIII MDRHIB

Overview Statistics

251
Total Inspections
143
Total 483s Issued
8
Warning Letters Issued

Inspection Details

Longest Inspection: 40 days
Shortest Inspection: 1 days
Average Length: 4.6 days

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James R Montero's Recent Inspections

DateCompanyCityCountryFEI Number483
2024-11-07Dexcom, Inc.San DiegoUnited States3004753838
2024-09-26Strub Medical GmbH & Co. KGNeuhausen Ob EckGermany3000226659
2024-09-19EPflex Feinwerktechnik GmbHDettingen An Der ErmsGermany3003289691
2024-09-12Analytic Biosurgical Solutions (ABISS)Saint-EtienneFrance3004756681
2024-08-23Myriad Genetics Laboratories, Inc.Salt Lake CityUnited States3030654068
2024-07-31iRhythm Technologies, Inc.CypressUnited States3021769057
2024-05-21Becton Dickinson Infusion Therapy Systems, Inc.SandyUnited States1710034
2024-05-03Stryker Neurovascular, Inc.Salt Lake CityUnited States3012931345
2024-04-05BioFire Diagnostics, LLCSalt Lake CityUnited States3002773840
2024-02-21Isansys Lifecare LtdAbingdonUnited Kingdom3011421364

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James R Montero - Co-Inspectors

NameInspectionsLast Inspection
Jessie E Morris52011
Rebecca L Stephany42022
Christina A Mayer42017
Janet Pulver42014
Brent W Higgs42011
Jennifer L Wolfe42009
Nathan R Moon32012
Ginger M Sykes32011
Katlin N Stubbs22024
Matthew M Vernon22018
William A Lanier22014
Justin H Erickson22014
Daniel J Lahar22012
Neira Acevedo-Ramos22010
Adam J Ruben12024
Nga T Ho12024
Mary A Millner12024
Nancy Bogdanovic12023
Jacey Roy12023
Jenny L Chisem12022
Jenny L Mccardell12022
Paul M Kawamoto12020
Juanj Wu12019
Juanj N Wu12019
Shelby N Marler12018
Constance M Dobbins12018
Michael L Jones12018
Aqualia L Nelson12018
Ed Gonzalez Vazquez12018
Brandi E Williams12018
Hung V Le12018
Danielle Lyke12018
James Coburn12017
Vicky L Cruz12017
Richard T Jensen12017
Christine I Shaw12016
Matthew A Kozler12016
Ashleigh P Wodushek12015
Thai T Duong12015
Marion W Nadeau12015
Amanda S Zorn12014
Sean T Creighton12014
Matthew A Johnson12013
Randy V Bong12012
Marc A Jackson12012
Kelly D Moore12012
Bryan J Love12011
Linda F Murphy12011
Matthew J Hansen12010
Ricki A Chase12009
Christin L Torres12009
Traci B Bickell12009
Isabel Y Espinosa12009
Marie B Buen-Bigornia12009

James R Montero's Active Locations

  • United States
  • Germany
  • China
  • Italy
  • United Kingdom
  • France
  • Japan
  • Netherlands
  • Poland
  • Switzerland
  • Romania
  • Hungary
  • Costa Rica
  • Argentina
  • Finland
  • Bulgaria
  • Australia
  • Sweden
  • Czech Republic
  • Singapore
  • Indonesia
  • Brazil
  • Taiwan

James R Montero's Year-wise Inspection Count

  • 2009:17 inspections
  • 2010:10 inspections
  • 2011:20 inspections
  • 2012:15 inspections
  • 2013:15 inspections
  • 2014:17 inspections
  • 2015:15 inspections
  • 2016:16 inspections
  • 2017:26 inspections
  • 2018:18 inspections
  • 2019:26 inspections
  • 2020:4 inspections
  • 2021:2 inspections
  • 2022:17 inspections
  • 2023:20 inspections
  • 2024:13 inspections
Last Updated: 2025-05-14 06:11:22