FDA Investigator Edmund F Mrak, Jr

Edmund F Mrak, Jr has inspections in 15 countries as of 25 Oct 2023. Edmund F Mrak, Jr has collaborated with a combinined 10149 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
168
Last Inspection Date:
25 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Canada, Denmark, Switzerland, Korea (Republic of), India, Germany, China, Italy, Spain, Croatia, Austria, Sweden, France
Co-Investigator(s):
Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Aditi S Thakur, Alan R Condon, Alberto A Viciedo, Alice C Silva, Alice S Tsao, Alison N Stieg, Allison A Aldridge, PhD, Alois P Provost, Alysia M Salonia, Alyssa R Favro, Amber G Wardwell, Amy C Jordan, Amy L Singer, Amy N Chen, Andrew M Barlow, Angela E Glenn, Anita Narula, PhD, Anita R Michael, Anjali Shukla, PhD, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Annet R Rajan, Anthony C Warchut, Arie C Menachem, Ariel Cruz Figueroa, Ashley M Whitehurst, Avital A Shimanovich, Azza Talaat, Barbara A Gullick, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Bijoy Panicher, Bijoy Panicker, Bill Tacket, Jr, Blondell W Johnson, Bo Chi, PhD, Bogdan Kurtyka, Bradford L Swanson, Brandy L Couillard, Brandy L Gillilan, Brandy N Lepage, Brenda P King, Brenna L Macdowell, Brian D Nicholson, Brian J Ryan, Brooke K Higgins, Bruce G Cooper, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Camerson E Moore, Camerson E Murray, Carl A Huffman, III, Carla C Cummins, Carla C Tuite, Carla J Lundi, Carlos Chavez, Caryn M Mcnab, Cassandra L Abellard, CDR Donald Ertel, CDR Ileana Barreto Pettit, Celia N Cruz, Chaltu N Wakijra, Charanjeet Jassal, Charisse K Green, Charles D Brown, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Chelsea N Sealey, Chhaya S Shetty, Chiang Syin, PhD, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Christina K Theodorou, Christine M Smith, Christopher D Leach, Christopher Janik, Christopher T Middendorf, Chunchun Zhang, Chunsheng Cai, PhD, Constance Desimone, Courtney N Long, Craig D Zagata, Craig T Rybus, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Daniel C Mccoham, Daniel E Needham, Daniel J Grabicki, Daniel J Roberts, Daniel L Zheng, Darin S Wiegers, Daryl A Dewoskin, David A Oluwo, David G Eng, David J Gomes, David J Hafner, David M Beltran, David P Vanhouten, David S Firley, David Van Houten, Dawn L Wydner, Dean R Rugnetta, Deborah J Parris, Debra I Love, Dell S Moller, Denise L Terzian, Denise M Digiulio, Destry M Sillivan, Deyaa Shaheen, Diane C Thibodeau, Diane L Raccasi, Diane M Fresch, Diane M Prince, Diantha M Turner, Dien N Nguyen, Dino Feigelstock (DF), PhD, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald G Gordon, Donald H Barks, Donald L Lech, Dongping Dai, PhD, Dorothy W Lee, Douglas A Campbell, Douglas Florentino, Douglas S Joslin, Dr. Carmelo Rosa, Dr. Dominick Roselle, Dr. Erika A Pfeiler, Dr. Gang Wang, PhD, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Sriram Subramaniam, PhD, Dr. Willie F Vann, PhD, Dr. Yubing Tang, Edmund Fmrak J, Edmund Fmrakjr S, Edmund Mrak, Edward J Janik, Eileen A Liu, Eliezar Ramos, Elizabeth Ll Edwards, Elizabeth P Mayer, Ellen C Weisensel, Ellen P Madigan, Emest F Bizjak, Eric C Schmitt, Eric L Dong, BS, Erik W Koester, Erika V Butler, Erin I Keith, Erk W Koester, Felix Maldonado, Frank J Marciniak, Frederick Razzaghi, Gabrielle J Swain, Ganesh N Joshi, Garry H Stewart, Gary J Hagan, Gary J Lehr, Gary T Greco, George M Ibrahim, George Pyramides, George T Allen, Jr, Gerald B Seaborn, Jr, Gerard D Difiore, Ginger M Sykes, Gordon, Greg W Hites, Guerlain Ulysse, Gwyn G Dickinson, Haley H Seymour, Hang N Guo, Harperd, Harry J Brewer, Hasan A Irier, PhD, Hector J Colon Torres, Helen B Ricalde, Hugh M Mcclure, II, Isaac K Carney, Jacek Cieslak, PhD, Jack Ragheb, Jacqueline Mdiaz Albertini, James A Liubicich, James C Maclaughlin, James D Bridges, James E Keller, PhD, James I Giefer, James K Mcnally, James L Dunnie, Jr, James M Mason, James M Simpson, James Norman, James P Stumpff, James R Evans, James W Whitney, Jamie S Mathews, Jason B Prosser, Jason D Abel, Javier O Vega, Jawaid Hamid, Jay B Shah, Jayaleka J Amarasinghe, Jazmine N Brown, Jazmine N Still, Jeffery A Hangartner, Jeffrey D Meng, Jeffrey J Thibodeau, Jennifer C Adams, Jennifer L Schmidt, Jennifer Lalama, Jennifer M Gogley, Jianming Li, Joan A Loreng, Joan M Cantellops Figueroa, Jogy George, John A Gonzalez, John A Sciacchitano, John L Zaccone, John P Mistler, John P Shelton, John R Tuohig, John S Hartford, Johnna L Bleem, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan G Matrisciano, Jonathan G Matrsciano, Jonathan W Chapman, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Jose O Hernandez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph Frost, Joseph George, Joseph J Vannelli, Joseph T Frost, Joseph W Matthews, Joy Rkozlowski Klena, Joyce A Kellett, Juan Rjimenez Garcia, Juanita P Versace, Julie D Bringger, Jun Park, PhD, Junho Pak, Justin A Boyd, Justine M Corson, Justine Tomasso, Kalavati Suvarna, PhD, Karen A Briggs, Karen E D'orazio, Karen Mcnabb Noon, Karishma G Gopaul, Karl Auguste, Katherine E Jacobitz, Katherine Szestypalow, Kathleen M Jordan, Kelli F Dobilas, Kellia N Hicks, Kenneth Gordon, Kenneth H Williams, Kenneth M Gordon, Kenneth Nieves, Kent A Conforti, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberly M White, Ko U Min, Kristina J Donohue, Kristina L Conroy, Larry K Austin, Latorie S Jones, Laurel A Beer, Laurie B Frazier, Laurie P Norwood, Laurimer Kuilan Torres, Lawrence Harmon, Jr, Lawrence J Stringer, Lawrence W Farina, LCDR Chad N Thompson, LCDR Debra Emerson, Lei Zhang, PhD, Leiyun Boone, PhD, Leo B Zadecky, Lewis K Antwi, Linda F Murphy, Linda M Cheny, Linda Thai, Lisa M Romano, Loretta J Miller, Lori A Holmquist, Lori M Newman, Lori S Lawless, Louis Christy, LT John M Mastalski, Luis A Dasta, Lydia Irosas Marty, M Patriciaurphy Murphy, Marc S Neubauer, Marcellinus D Dordunoo, Marcus A Ray, Marea K Harmon, Margaret E Sarles, Margaret M Annes, Margaret M Doherty, Margaret M Sands, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marie Bbuen Bigornia, Marijo B Kambere, PhD, Marilyn Welchenbach, Marion Michaelis, Mariza M Jafary, Mark E Farrell, Mark R Mcclain, Marlene G Swider, Martin J Guardia, Mary Jeanet Mcgarry, Marybet Lopez, Massoud Motamed, Matthew B Casale, Matthew C Watson, Matthew D Silverman, Matthew M Henciak, Matthew R Sleeter, Maxim, Maya M Davis, Megan A Haggerty, Mei Chiung J Huang, Melissa J Garcia, Merry Christie, PhD, Meyer J Slobotsky, Michael A Charles, Michael E Maselli, Michael G Sinkevich, Michael J Casey, Michael P Anthony, Michael P Sheehan, Michael R Klapal, Michael Shanks, MS, Michele L Forster, PhD, Michele L Obert, Michelle L Dragon Nagel, Michelle M Noe, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Milan S Mcgorty, Mindy M Chou, Minh D Phan, Monique C Lo, Mra Mcculloughj, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nailing Zhang, Nancy A Saxenian, Nancy A Saxenian Emmons, Nancy T Waites, Nasser Yazdani, Nealie C Newberger, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Nicholas A Violand, Nicholas J Scire, Nicholas L Paulin, Nichole B Murphy, Nicole J Clausen, Nicole K Trudel, Niketa Patel, Nikisha M Bolden, Nina Yang, Oganr, Ogechi C Nna, Omotunde O Osunsanmi, Osama A Khatib, Pamela L Ogonowski, Paraluman S Leonin, Parul M Patel, Patricia Fhughes Troost, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paula A Trost, Paula Laplant, Paula M Laplant, Perry H Gambrell, Peter E Baker, Peter R Lenahan, Philip F Istafanos, DMV, MS, Philip Kreiter, Phillip E Mclaughlin, Prabhu P Raju, Pushpa S Jayasekara, Qing Joanna Zhou, PhD, Rachael A Moliver, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Rafael E Arroyo, Ramon E Martinez, Randy L Self, Rapti D Madurawe, Reba A Gates, Rebecca K Olin, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard B Mcaroy, Richard F Hapke, Richard H Penta, Richard Ledwidge (nmi), PhD, Richard W Thornton, Robert C Coleman, Robert C Steyert, Robert D Ogan, Robert D Tollefsen, Robert E Teel, Robert H Wittorf, Robert J Martin, Robert J Veitch, Robert Mo Brien, Robert Sausville, Rochelle K Kimmel, Roger F Zabinski, Ronald G Crawford, Rory K Geyer, Rose M Ashley, Rupa Pradhan, Russell J Glapion, Saleem A Akhtar, Samantha J Bradley, Samina S Khan, Samir C Gala, Samuel Mindaye, Sandra A Hughes, Sandra P White, Sangeeta M Khurana, PhD, Santos E Camara, Sarah A Meehan, Sarah A Wangseng, Sarah Adella Fave, Sarah B Tanksley, Sarah E Mcmullen, Saundrea A Munroe, Scott C Lute, Scott Lute, Scott M Loughan, Scott R Nichols, PhD, Scott T Ballard, Sean R Bryd, Sean R Marcsisin, Seneca D Toms, Shari L Kahn, Sharmista Chatterjee, Sharon K Thoma, PharmD, Sharon Rhew, Shawn R Gould, Shirley S Wen, Shirshendu K Deb, PhD, Sidney B Priesmeyer, Simone E Pitts, Sixto M Mercado Rios, Slater K Bartlett, Solomon Yimam (SY), Sony Mathews, Sripal R Mada, PhD, Stacey S Degarmo, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen C King, Stephen C Smith, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steve Y Rhieu, PhD, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Susan F Laska, MS, Susan Krishner, Susan M Jackson, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Tamara S Rosbury, Tamil Arasu, PhD, Tania K Mercado, Tanya R Syffrard, Terri L Dodds, Thai T Duong, Thomas A Peter, Thomas E Friel, Thomas J Arista, Thomas J Mooney, Thomas O Morgan, Thomas W Nerney, Thomas W Nojek, Thuy T Nguyen, LCDR, Timothy T Kapsala, Tina S Roecklein, Tonia F Bernard, Torrance J Slayton, Toyin B Oladimeji, Travis S Bradley, Troy R Petrillo, Unnee Ranjan, Victoria M Daddeo, Victoria Spivak, Vidya B Pai, Vilmary Negron Rodriguez, Vioela J Caze, Viviana Matta, Vivin George, Vlada Matusovsky, Walter L Fava, Wanda Y Honeyblue, Wayne E Seifert, Wealie C Newberger, Wei Wang, PhD, William Hallett, PhD, William J Leonard, William M Rennells, Willis I Cobb Jr, Xianghong Jing (Emily), PhD, Xiaokuang Lai, PhD, Xiomara Copeland, Yan Wang, Yetao Jin, PhD, Ying Xin Fan, PhD, Yong Hu, Yong Wang, Youmin Wang, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Zachary L Miller, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu, Ziyang Su, PhD

Edmund F Mrak, Jr's Documents

Publish Date Document Type Title
July, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-07-10
February, 2014 FDA 483 Central Admixture Pharmacy Services, Inc. - Form 483, 2014-02-20
January, 2017 FDA 483 Edge Pharma, LLC - Form 483, 2017-01-20
April, 2023 EIR Sanofi Pasteur Inc. - EIR, 2023-04-22
February, 2022 FDA 483 Guardian Drug Company - Form 483, 2022-02-17
December, 2017 EIR Airgas Usa, LLC - EIR, 2017-12-13
July, 2019 FDA 483 M Drug, LLC dba Northern Light Pharmacy - Form 483, 2019-08-20
October, 2022 FDA 483 AllerQuest LLC - Form 483, 2022-10-21
April, 2014 FDA 483 Hisun Pharmaceutical (Hangzhou) Co., Ltd. - Form 483, 2014-04-11
April, 2016 EIR InvaGen Pharmaceuticals, Inc - EIR, 2016-04-30
August, 2014 FDA 483 Edge Pharma, LLC - Form 483, 2014-08-20
December, 2019 FDA 483 Autumn Harp, Inc. - Form 483, 2019-12-19
August, 2022 FDA 483 ImClone Systems LLC - Form 483, 2022-08-25
May, 2017 FDA 483 Haematologic Technologies, LLC dba Prolytix - Form 483, 2017-05-11
January, 2022 FDA 483 Colorlab Cosmetics, Inc. - Form 483, 2022-01-06
November, 2016 FDA 483 Sandoz GmbH - Form 483, 2016-11-17
August, 2020 FDA 483 Twincraft Inc - Form 483, 2020-08-25
December, 2017 FDA 483 Response Airgas Usa, LLC - Form 483R, 2018-01-05
January, 2016 FDA 483 New England Home Therapies, Inc - Form 483, 2016-01-27
September, 2016 FDA 483 Response Vertex Pharmaceuticals Incorporated - Form 483R, 2016-10-11
April, 2016 EIR Mylan Technologies Inc. - EIR, 2016-04-13
November, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-11-19
May, 2015 FDA 483 Merissa corp. DBS Johnson Compounding and Wellness - Form 483, 2015-05-28
May, 2016 FDA 483 RESONANCE LABORATORIES PRIVATE LIMITED - Form 483, 2016-05-06
November, 2011 FDA 483 B.M.P. Bulk Medicines & Pharmaceuticals GmbH - Form 483, 2011-11-16
October, 2015 FDA 483 Wasserburger Arzneimittelwerk GmbH - Form 483, 2015-10-27
February, 2018 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2018-02-01
March, 2012 FDA 483 Exemplar Pharmaceuticals LLC - Form 483, 2012-03-21
January, 2012 FDA 483 Exemplar Pharmaceuticals LLC - Form 483, 2012-01-13
June, 2022 FDA 483 Hikma Injectables USA Inc. - Form 483, 2022-06-08
October, 2010 FDA 483 Moark Maine Site 9 Plant - Form 483, 2010-10-21
April, 2015 FDA 483 Sandoz GmbH - Form 483, 2015-04-30
December, 2009 FDA 483 Natural Patches of Vermont, Inc. - Form 483, 2009-12-16
October, 2018 FDA 483 Intact Pharmaceuticals LLC - Form 483, 2018-10-12
July, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-07-28
November, 2017 EIR CELLTRION PHARM, INC - EIR, 2017-11-17
April, 2018 FDA 483 EyePoint Pharmaceuticals US, Inc. - Form 483, 2018-04-04
November, 2014 FDA 483 Citra Labs, LLC - Form 483, 2014-11-21
March, 2023 FDA 483 Maimonides Medical Center - Pharmacy - Form 483, 2023-03-09
September, 2014 FDA 483 Innoteq, Inc. - Form 483, 2014-09-25
September, 2012 FDA 483 Cardinal Health 414, LLC - Form 483, 2012-09-05
February, 2016 FDA 483 Ocular Therapeutix, Inc. - Form 483, 2016-02-11
September, 2011 FDA 483 Tedor Pharma Inc. - Form 483, 2011-09-09
August, 2015 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2015-08-14
June, 2008 EIR Mylan Technologies Inc. - EIR, 2008-06-05
January, 2013 FDA 483 Pace Analytical Life Sciences, LLC - Form 483, 2013-01-10
October, 2019 FDA 483 Eurofins CDMO Alphora Inc - Form 483, 2019-10-11
November, 2021 FDA 483 SterRx, LLC - Form 483, 2021-11-04
February, 2022 FDA 483 Response Guardian Drug Company - Form 483R, 2022-02-17
June, 2023 FDA 483 SterRx, LLC - Form 483, 2023-06-28
September, 2019 EIR Pace Analytical Life Sciences, LLC - EIR, 2019-09-12
July, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-07-10
December, 2018 EIR SEAWAY PHARMA - EIR, 2018-12-10
January, 2015 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2015-01-13
July, 2020 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2020-07-30
November, 2011 EIR B.M.P. Bulk Medicines & Pharmaceuticals GmbH - EIR, 2011-11-16
October, 2014 FDA 483 Pace Analytical Life Sciences, LLC - Form 483, 2014-10-22
September, 2017 FDA 483 Citra Labs, LLC - Form 483, 2017-09-27
July, 2018 EIR Pfizer Laboratories Div Pfizer Inc - EIR, 2018-07-18
February, 2008 EIR PBM Nutritionals, LLC - EIR, 2008-02-29
July, 2018 FDA 483 Pfizer Laboratories Div Pfizer Inc - Form 483, 2018-07-18
July, 2020 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2020-07-30
December, 2018 FDA 483 SEAWAY PHARMA - Form 483, 2018-12-10
August, 2016 FDA 483 Bayview Pharmacy, Inc. - Form 483, 2016-08-18
November, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-11-19
October, 2010 FDA 483 Maine Contract Farming, Llc - Form 483, 2010-10-01
August, 2021 FDA 483 Aplicare Products, LLC - Form 483, 2021-08-03
August, 2013 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2013-08-05
October, 2012 FDA 483 USV Private Limited - Form 483, 2012-10-14
October, 2010 FDA 483 Dorothy Egg Farms, Llc - Form 483, 2010-10-21
July, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-07-10
December, 2017 FDA 483 Airgas Usa, LLC - Form 483, 2017-12-13
June, 2019 EIR Siegfried AG - EIR, 2019-07-26
August, 2016 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2016-08-03
October, 2011 EIR Mylan Technologies Inc. - EIR, 2011-10-31
December, 2022 FDA 483 CARBOGEN AMCIS AG - Form 483, 2022-12-16
December, 2022 FDA 483 Novartis Pharma Stein AG - Form 483, 2022-12-06
April, 2023 FDA 483 Sanofi Pasteur Inc. - Form 483, 2023-04-22
May, 2021 FDA 483 AllerQuest LLC - Form 483, 2021-05-03
April, 2013 EIR Mylan Technologies Inc. - EIR, 2013-04-30
March, 2018 FDA 483 New England Life Care, Inc. - Form 483, 2018-03-02
February, 2022 EIR Guardian Drug Company - EIR, 2022-02-17
April, 2023 FDA 483 Response Sanofi Pasteur Inc. - Form 483R, 2023-05-12
August, 2017 FDA 483 Resilience US, Inc. - Form 483, 2017-08-11
April, 2022 FDA 483 US Specialty Formulations LLC - Form 483, 2022-04-26
December, 2023 FDA 483 University System of New Hampshire - Form 483, 2023-12-05
January, 2024 FDA 483 Omega Laboratories - Form 483, 2024-01-17
September, 2023 FDA 483 SEAWAY PHARMA - Form 483, 2023-09-21

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