FDA Person
FDAEdmund F. Mrak
View detailed information about Edmund F. Mrak, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 60 inspections of 52 companies, 2016–2026.
Inspections (60)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 18, 2026 | Lotte Biologics USA, LLC | Not classified | #1341414 | |
| July 10, 2026 | Shine Spect USA, LLC | Not classified | Drug Quality Assurance | #1325866 |
| June 3, 2026 | Immunex Rhode Island Corporation | Not classified | #1324094 | |
| May 8, 2026 | Perrigo New York, Inc. | VAI | Drug Quality Assurance | #1316190 |
| April 10, 2026 | The Tender Corporation | Not classified | Drug Quality Assurance | #1301864 |
| March 3, 2026 | Vertex Pharmaceuticals Incorporated | NAI | Drug Quality Assurance | #1306258 |
| February 5, 2026 | N-Molecular, Inc. dba SOFIE | Not classified | #1290166 | |
| January 15, 2026 | Bionique Testing Laboratories LLC | Not classified | #1300474 | |
| November 20, 2025 | Medisca, Inc. | Not classified | #1293350 | |
| October 21, 2025 | Mylan Technologies, Inc. | NAI | Drug Quality Assurance | #1285894 |
| September 5, 2025 | AbbVie Bioresearch Center | Not classified | #1272372 | |
| June 18, 2025 | Seaway Pharma Inc. | OAI | Drug Quality Assurance | #1272511 |
| April 30, 2025 | Lohxa LLC | Not classified | Drug Quality Assurance | #1268356 |
| March 14, 2025 | BrittonField Laboratories Inc. | Not classified | #1263736 | |
| January 17, 2025 | SpecGx, LLC | Not classified | Drug Quality Assurance | #1256233 |
| November 15, 2024 | Anhydrous Brazil Extractions S.A. | Not classified | #1255476 | |
| September 19, 2024 | Lotte Biologics USA, LLC | NAI | Drug Quality Assurance | #1246771 |
| June 25, 2024 | Hikma Injectables USA Inc | Not classified | Drug Quality Assurance | #1242194 |
| April 24, 2024 | American Regent, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1236810 |
| April 3, 2024 | Bell-More Labs, Inc. | Not classified | Drug Quality Assurance | #1234928 |
Documents (52)
- 483 · Hikma Injectables USA Inc · June 8, 2022
- 483 · SterRx, LLC · November 4, 2021
- 483 · SterRx, LLC · June 28, 2023
- 483 · New England Life Care, Inc. · March 2, 2018
- 483 · Edge Pharma, LLC · August 20, 2014
- 483 · New England Home Therapies, Inc · January 27, 2016
- 483 · US Specialty Formulations LLC · April 26, 2022
- 483 · Hillandale Farms Conn, LLC · October 21, 2010
- 483 · Edge Pharma, LLC · January 20, 2017
- 483 · merissa corp. · May 28, 2015
- EIR · Guardian Drug Co. Inc. · February 17, 2022
- 483 · Intact Pharmaceuticals LLC · October 12, 2018
- 483 · M Drug, LLC dba Northern Light Pharmacy · July 19, 2019
- EIR · Sanofi Vaccines US Inc. · April 22, 2023
- 483 · Pharmaceutics International, Inc. · July 10, 2020
- 483 · American Regent, Inc. · April 24, 2024
- 483 · Bell-More Labs, Inc. · April 3, 2024
- 483 · Micro-Macinazione SA · May 31, 2019
- 483 · Central Admixture Pharmacy Services, Inc. · February 20, 2014
- 483 · Lohxa LLC · April 30, 2025
- 483 · Kumar Organic Products Ltd. · May 13, 2016
- EIR · Pharmaceutics International Inc · July 10, 2020
- 483 · Autumn Harp · December 19, 2019
- 483 · Element Materials Technology Canada Inc. · October 18, 2019
- EIR · Siegfried AG · June 14, 2019
- 483 · ImClone Systems, LLC · August 22, 2022
- 483 · Carbogen Amcis AG · December 12, 2022
- 483 · Medisca, Inc. · November 20, 2025
- 483 · Haematologic Technologies, LLC dba Prolytix · May 11, 2017
- 483 · BrittonField Laboratories Inc. · March 14, 2025
- 483 · Seaway Pharma Inc. · September 21, 2023
- 483 · University Instrumentation Center at UNH · December 5, 2023
- 483 · Omega Laboratories Ltd. · January 17, 2024
- 483 · Resilience US, Inc. · August 11, 2017
- 483 · Maimonides Medical Center - Pharmacy · March 9, 2023
- 483 · Novartis Pharma Stein AG · December 6, 2022
- 483 · Sanofi Vaccines US Inc. · April 22, 2023
- 483 · Seaway Pharma Inc. · June 18, 2025
- EIR · Pace Analytical Life Sciences · September 12, 2019
- 483 · SpecGx, LLC · January 17, 2025
- 483 · Colorlab Cosmetics, Inc. · January 6, 2022
- EIR · Pharmaceutics International, Inc. · July 10, 2020
- 483 · Twincraft Inc. · August 25, 2020
- 483 · ALK-Abello, Inc. · October 21, 2022
- 483 · Guardian Drug Co. Inc. · February 17, 2022
- EIR · Pfizer Inc. · July 18, 2018
- 483 · ALK-Abello, Inc. · May 3, 2021
- 483 · Aplicare Products, LLC · August 3, 2021
- 483 · Pharmaceutics International Inc · July 10, 2020
- 483 · Perrigo New York, Inc. · May 8, 2026
- 483 · Maine Contract Farming, LLC · October 1, 2010
- 483 · Shine Spect USA, LLC · July 10, 2026
Frequently inspected with (10)
Armen H. Youssoufian
6 shared
Ifechimere I. Okafor
investigator
4 shared
Ogechi C. Nna
4 shared
Jonathan G. Matrisciano
Program Division Director/District Director
3 shared
David Eng
2 shared
John D. McIntosh
2 shared
Karishma G. Gopaul
Investigator
2 shared
Lori M. Newman
Deputy Director
2 shared
Andrew O. Ejiofor
1 shared
Bijoy Panicker
1 shared
Person Information
Name
Edmund F. Mrak
Title
Investigator
Role
Regulatory Personnel
ID: a43cf86a-c020-4948-bff6-358b2453908a
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