Edmund F Mrak - FDA Investigator Report

Designation: CSO(DRUGS)

Duty Station: Highgate Springs VT 05460

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Overview Statistics

174
Total Inspections
130
Total 483s Issued
7
Warning Letters Issued

Inspection Details

Longest Inspection: 64 days
Shortest Inspection: 1 days
Average Length: 8.1 days

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Edmund F Mrak's Recent Inspections

DateCompanyCityCountryFEI Number483
2025-03-14Brittonfield Laboratories Inc.East SyracuseUnited States3022352136
2025-01-17SpecGx LLCHobartUnited States1317295
2024-11-15Anidro Do Brasil Extracoes S.A.ParnaibaBrazil3002807563
2024-09-19Lotte Biologics USA, LLCEast SyracuseUnited States1317757
2024-06-25Hikma Injectables USA IncDaytonUnited States3022897129
2024-04-24American Regent, Inc.ShirleyUnited States2410375
2024-04-03Bell-More Labs, Inc.HampsteadUnited States1150023
2024-01-26Delpharm Boucherville Canada, Inc.BouchervilleCanada3000280957
2024-01-17Omega Laboratories Ltd.MontrealCanada3004153143
2023-12-05University Instrumentation Center at UNHDurhamUnited States3002813858

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Edmund F Mrak - Co-Inspectors

Edmund F Mrak's Active Locations

  • United States
  • Switzerland
  • Canada
  • India
  • Germany
  • Denmark
  • Korea (the Republic of)
  • China
  • Spain
  • Austria
  • Sweden
  • Croatia
  • France
  • Italy
  • Brazil

Edmund F Mrak's Year-wise Inspection Count

  • 2008:12 inspections
  • 2009:8 inspections
  • 2010:9 inspections
  • 2011:12 inspections
  • 2012:13 inspections
  • 2013:14 inspections
  • 2014:11 inspections
  • 2015:10 inspections
  • 2016:12 inspections
  • 2017:15 inspections
  • 2018:9 inspections
  • 2019:13 inspections
  • 2020:9 inspections
  • 2021:5 inspections
  • 2022:8 inspections
  • 2023:5 inspections
  • 2024:7 inspections
  • 2025:2 inspections
Last Updated: 2025-05-14 06:11:22