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
Total Inspections: 251
Total 483s Issued: 143
Total Warning Letters Issued: 7
Inspection Details
Longest Inspection: 40 days
Shortest Inspection: 1 days
Average Length of Inspection: 4.6 days
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Schedule a DemoRecent Inspections
Date | Company | City | Country | FEI Number | 483 |
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2024-11-07 | Dexcom, Inc. | San Diego | United States | 3004753838 | |
2024-09-26 | Strub Medical GmbH & Co. KG | Neuhausen Ob Eck | Germany | 3000226659 | |
2024-09-19 | EPflex Feinwerktechnik GmbH | Dettingen An Der Erms | Germany | 3003289691 | |
2024-09-12 | Analytic Biosurgical Solutions (ABISS) | Saint-Etienne | France | 3004756681 | |
2024-08-23 | Myriad Genetics Laboratories, Inc. | Salt Lake City | United States | 3030654068 | |
2024-07-31 | iRhythm Technologies, Inc. | Cypress | United States | 3021769057 | |
2024-05-21 | Becton Dickinson Infusion Therapy Systems, Inc. | Sandy | United States | 1710034 | |
2024-05-03 | Stryker Neurovascular, Inc. | Salt Lake City | United States | 3012931345 | |
2024-04-05 | BioFire Diagnostics, LLC | Salt Lake City | United States | 3002773840 | |
2024-02-21 | Isansys Lifecare Ltd | Abingdon | United Kingdom | 3011421364 | |
Co-Inspectors
Active Locations
- United States
- Germany
- China
- Italy
- United Kingdom
- France
- Japan
- Netherlands
- Poland
- Romania
- Switzerland
- Hungary
- Argentina
- Costa Rica
- Finland
- Bulgaria
- Australia
- Sweden
- Czech Republic
- Indonesia
- Singapore
- Brazil
- Taiwan
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