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

NameInspectionsLast Inspection
Lori M Newman52025
Joseph T Frost52011
Isaac K Carney52011
Jonathan G Matrisciano42019
Maya M Davis42014
Russell J Glapion32015
Brandy L Couillard32011
Ogechi C Nna22024
Robert J Martin22020
Sean R Marcsisin22018
David Eng22016
Nealie C Newberger22016
Richard B Mcaroy22015
David J Gomes22014
Bruce G Cooper22010
Richard F Hapke22010
Dean R Rugnetta22008
Lauren H Augustyniak12025
Emmanuel T Donyina12025
Paige R Mccoy12025
Armen H Youssoufian12025
Luxuly Abraham12024
John D Mcintosh12024
Andrew O Ejiofor12024
Christian F Gomez Lugo12024
Frederick Razzaghi12024
Bijoy Panicker12024
Karishma G Gopaul12023
Pushpa S Jayasekara12023
Victoria Spivak12023
John R Tuohig12022
Jay B Shah12022
Samir C Gala12022
Kathleen M Jordan12022
Wayne E Seifert12022
Ko U Min12022
Tanya R Syffrard12021
Brandy N Lepage12021
Rachael O Oyewole12020
Johnna L Bleem12019
Hang N Guo12018
Yong Wang12018
Steve Y Rhieu12018
Chunsheng Cai12018
Rapti D Madurawe12018
Djamila Harouaka12018
Dien N Nguyen12017
Diane L Raccasi12017
Diane M Prince12016
Kenneth H Williams12016
Vioela J Caze12016
Aditi Thakur12016
Deborah J Parris12015
Mary-Jeanet Mcgarry12015
Carlos Chavez12015
Arie Menachem12015
Jayaleka J Amarasinghe12014
Erik W Koester12014
Camerson E Moore12014
Thomas J Arista12013
Debra M Emerson12013
Barbara J Wilimczyk-Macri12011
Louis Christy12010
James K Mcnally12010
Robert C Horan12010
Martin J Guardia12008
Troy R Petrillo12008
Paula M Laplant12008

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