FDA Investigator Edmund F Mrak, Jr

Edmund F Mrak, Jr has conducted inspections on 173 sites in 14 countries as of 10 Apr 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
173
Last Inspection Date:
10 Apr 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Switzerland, Korea (Republic of), Germany, India, Canada, France, Spain, Denmark, Austria, Croatia, China, Sweden, Italy
FDA Investigators that have inspected at least one site in common with Edmund F Mrak, Jr:
Adam R Cooke, Ademola O Daramola, Adena S Yau, 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, Althea A Williams, Alysia M Salonia, Alyssa R Favro, Amber G Wardwell, Amy C Jordan, Amy L Singer, Amy N Chen, Andrew M Barlow, Andrew O Ejiofor, 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, Armen H Youssoufian, Ashley M Whitehurst, Avital A Shimanovich, Azza Talaat, Barbara A Gullick, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, 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, Brett R Havranek, Brian D Nicholson, Brian J Ryan, Brooke K Higgins, Brooke K Seeman, Bruce G Cooper, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Camerson E Moore, Carl A Huffman, III, Carla C Cummins, Carla C Tuite, Carla J Lundi, Carlos Chavez, Carole L Jones, Caryn M Mcnab, Cassandra L Abellard, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, Celia N Cruz, Chaltu Nwakijra, 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 Whitby, CSO, Christopher D Leach, Christopher Janik, Christopher T Middendorf, Chunchun Zhang, Chunsheng Cai, PhD, Colleen F Hoyt, 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, Dawn L Wydner, Dean R Rugnetta, Deborah J Parris, Debra I Love, Dell S Moller, Demitria J Xiradakis, Denise L Terzian, Denise M Digiulio, Dennis E Guilfoyle, PhD, Destry M Sillivan, Deyaa Shaheen, Diane C Thibodeau, Diane L Raccasi, Diane M Fresch, Diane M Prince, Diane T Bargo, Diane T O'brien, Diantha M Turner, Dien N Nguyen, Dino A Fiegelstock, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Dolores Harper, 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 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, Dr. Zhihao Qiu (Peter), PhD, Edward J Janik, Edwin Melendez, 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, Eric S Weilage, Erika V Butler, Erin I Keith, Felix Maldonado, Frank J Marciniak, Frank Verni, Frederick F 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, Greg W Hites, Guerlain Ulysse, Gwyn G Dickinson, Haley H Seymour, Hang N Guo, Harry J Brewer, Hasan A Irier, PhD, Hector Jcolon Torres, Helen B Ricalde, Hugh M Mcclure, II, Isaac K Carney, Jacek Cieslak, PhD, Jack Ragheb, Jackson Y See, 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, Jessica Chery, Jianming Li, Jigar R Patel, 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, Jonathan G Matrisciano, Jonathan W Chapman, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose Martinez, Jr, 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, 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, Kathleen R Jones, PhD, Kelli F Dobilas, Kellia N Hicks, 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, Kula N Jha, Larry K Austin, Latorie S Jones, Laurel A Beer, Laurie A Haxel, Laurie B Frazier, Laurie P Norwood, Laurimer Kuilan Torres, Laurissa S Flowers, Lawrence Harmon, Jr, Lawrence J Stringer, Lawrence W Farina, LCDR Anastasia M Piliafas Brown, LCDR Chad N Thompson, LCDR Debra Emerson, Lei Zhang, PhD, Leiyun Boone, PhD, Leo B Zadecky, Lewis K Antwi, Libia M Lugo, 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 I Rosas Marty, 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 B Buen 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 Negron, Massoud Motamed, Matthew B Casale, Matthew C Watson, Matthew D Silverman, Matthew M Henciak, Matthew R Sleeter, Maya M Davis, Megan A Haggerty, Mei Chiung Huang (Jo), Melissa J Garcia, Meredith L Miller, Merideth K Rose, Merry Christie, PhD, Meyer J Slobotsky, Michael A Charles, Michael E Maselli, Michael G Sinkevich, Michael J Casey, Michael L Casner, Michael O Idowu, 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 Varga, Michelle Yclark Stuart, Miguel A Martinez Perez, 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 Emmons, Nancy T Waites, Nasser Yazdani, DVM, MPH, Nealie C Newberger, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, 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, Otto D Vitillo, Paige R Mccoy, Pamela L Ogonowski, Paraluman S Leonin, Parul M Patel, Patricia A Morrow, Patricia F Hughes, PhD, 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 M Laplant, Perry H Gambrell, Peter Abel, Peter E Baker, Peter R Lenahan, Philip F Istafanos, DMV, MS, Philip Kreiter, Phillip E Mclaughlin, Prabhu P Raju, Puspa Suresh Jayasekara, Qing Joanna Zhou, PhD, Rachael A Moliver, Rachael O Oyewole, Rachel C Harrington, Rafael E Arroyo, Ramon A Hernandez, Ramon E Martinez, Randy L Self, Rapti D Madurawe, Raymond T Oji, 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 O'brian, Robert Sausville, Rochelle K Kimmel, Roger F Zabinski, Ronald G Crawford, Rory K Geyer, Rose 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, Sarah E Rhoades, Saundrea A Munroe, Scott C Lute, Scott M Loughan, Scott R Nichols, PhD, Scott T Ballard, 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, Shusheen A Alexander, 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, 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, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan Kirshner, Susan M Jackson, Susan T Hadman, Susanna E Ford, Susanne M Richardson, MS RAC, Suzanne M Healy, Suzanne M Muchene, Tajah L Blackburn, 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, Valerie A Potopsingh, Victoria M Daddeo, Victoria Spivak, Vidya B Pai, Vilmary Negron Rodriguez, Vioela J Caze, Vipulchandra N Dholakia, Viviana Matta, Vivin George, Vlada Matusovsky, Walter L Fava, Wanda Y Honeyblue, Wayne E Seifert, 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, Zhong Li, PhD, Zhongren Wu, Ziyang Su, PhD

Edmund F Mrak, Jr's Documents

Publish Date Document Type Title
October, 2010 FDA 483 Dorothy Egg Farms, Llc - Form 483, 2010-10-21
August, 2013 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2013-08-05
July, 2018 EIR Pfizer Laboratories Div Pfizer Inc - EIR, 2018-07-18
December, 2017 FDA 483 AIRGAS USA, LLC - Form 483, 2017-12-13
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
May, 2021 FDA 483 ALK-ABELLO, INC. - Form 483, 2021-05-03
July, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-07-10
October, 2012 FDA 483 USV Private Limited - Form 483, 2012-10-14
September, 2019 EIR Pace Analytical Life Sciences, LLC - EIR, 2019-09-12
October, 2010 FDA 483 Maine Contract Farming, Llc - Form 483, 2010-10-01
March, 2012 FDA 483 Exemplar Pharmaceuticals LLC - Form 483, 2012-03-21
January, 2012 FDA 483 Exemplar Pharmaceuticals LLC - Form 483, 2012-01-13
April, 2013 EIR Mylan Technologies Inc. - EIR, 2013-04-30
March, 2023 FDA 483 Maimonides Medical Center - Pharmacy - Form 483, 2023-03-09
April, 2014 FDA 483 Hisun Pharmaceutical (Hangzhou) Co., Ltd. - Form 483, 2014-04-11
October, 2019 FDA 483 Eurofins CDMO Alphora Inc - Form 483, 2019-10-11
August, 2017 FDA 483 Resilience US, Inc. - Form 483, 2017-08-11
November, 2017 EIR CELLTRION PHARM, INC - EIR, 2017-11-17
January, 2015 FDA 483 Sun Pharmaceutical Industries, Inc. - Form 483, 2015-01-13
April, 2023 FDA 483 Response Sanofi Pasteur Inc. - Form 483R, 2023-05-12
February, 2022 FDA 483 Guardian Drug Company - Form 483, 2022-02-17
October, 2015 FDA 483 Wasserburger Arzneimittelwerk GmbH - Form 483, 2015-10-27
April, 2018 FDA 483 EyePoint Pharmaceuticals US, Inc. - Form 483, 2018-04-04
January, 2024 FDA 483 Delpharm Boucherville Canada Inc - Form 483, 2024-01-26
July, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-07-10
April, 2016 EIR InvaGen Pharmaceuticals, Inc - EIR, 2016-04-30
August, 2022 FDA 483 ImClone Systems LLC - Form 483, 2022-08-25
August, 2021 FDA 483 Aplicare Products, LLC - Form 483, 2021-08-03
April, 2023 EIR Sanofi Pasteur Inc. - EIR, 2023-04-22
May, 2015 FDA 483 Merissa corp. DBS Johnson Compounding and Wellness - Form 483, 2015-05-28
February, 2014 FDA 483 Central Admixture Pharmacy Services, Inc. - Form 483, 2014-02-20
January, 2013 FDA 483 Pace Analytical Life Sciences, LLC - Form 483, 2013-01-10
May, 2016 FDA 483 Resonance Laboratories Private Limited - Form 483, 2016-05-06
June, 2022 FDA 483 Hikma Injectables USA Inc. - Form 483, 2022-06-08
February, 2018 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2018-02-01
January, 2017 FDA 483 Edge Pharma, LLC - Form 483, 2017-01-20
November, 2011 FDA 483 B.M.P. Bulk Medicines & Pharmaceuticals GmbH - Form 483, 2011-11-16
October, 2010 FDA 483 Moark Maine Site 9 Plant - Form 483, 2010-10-21
November, 2021 FDA 483 SterRx, LLC - Form 483, 2021-11-04
November, 2014 FDA 483 Citra Labs, LLC - Form 483, 2014-11-21
June, 2008 EIR Mylan Technologies Inc. - EIR, 2008-06-05
July, 2018 FDA 483 Pfizer Laboratories Div Pfizer Inc - Form 483, 2018-07-18
June, 2023 FDA 483 SterRx, LLC - Form 483, 2023-06-28
August, 2015 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2015-08-14
April, 2024 FDA 483 American Regent, Inc. - Form 483, 2024-04-24
October, 2020 FDA 483 MEDISCA Inc. - Form 483, 2020-10-06
October, 2018 FDA 483 Intact Pharmaceuticals LLC - Form 483, 2018-10-12
August, 2014 FDA 483 Edge Pharma, LLC - Form 483, 2014-08-20
July, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-07-28
February, 2022 FDA 483 Response Guardian Drug Company - Form 483R, 2022-02-17
October, 2014 FDA 483 Pace Analytical Life Sciences, LLC - Form 483, 2014-10-22
September, 2012 FDA 483 Cardinal Health 414, LLC - Form 483, 2012-09-05
August, 2016 FDA 483 Bayview Pharmacy, Inc. - Form 483, 2016-08-18
November, 2010 EIR Altaire Pharmaceuticals Inc. - EIR, 2010-11-19
July, 2020 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2020-07-30
January, 2022 FDA 483 Colorlab Cosmetics, Inc. - Form 483, 2022-01-06
August, 2020 FDA 483 Twincraft Inc - Form 483, 2020-08-25
April, 2022 FDA 483 US Specialty Formulations LLC - Form 483, 2022-04-26
September, 2017 FDA 483 Citra Labs, LLC - Form 483, 2017-09-27
October, 2022 FDA 483 ALK-ABELLO, INC. - Form 483, 2022-10-21
July, 2020 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2020-07-30
September, 2011 FDA 483 Tedor Pharma Inc. - Form 483, 2011-09-09
September, 2023 FDA 483 SEAWAY PHARMA - Form 483, 2023-09-21
September, 2014 FDA 483 Innoteq, Inc. - Form 483, 2014-09-25
December, 2023 FDA 483 University System of New Hampshire - Form 483, 2023-12-05
July, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-07-10
December, 2017 EIR AIRGAS USA, LLC - EIR, 2017-12-13
December, 2019 FDA 483 Autumn Harp, Inc. - Form 483, 2019-12-19
November, 2011 EIR B.M.P. Bulk Medicines & Pharmaceuticals GmbH - EIR, 2011-11-16
February, 2016 FDA 483 Ocular Therapeutix, Inc. - Form 483, 2016-02-11
April, 2023 FDA 483 Sanofi Pasteur Inc. - Form 483, 2023-04-22
February, 2008 EIR PBM Nutritionals, LLC - EIR, 2008-02-29
May, 2017 FDA 483 Haematologic Technologies, LLC dba Prolytix - Form 483, 2017-05-11
September, 2016 FDA 483 Response Vertex Pharmaceuticals Incorporated - Form 483R, 2016-10-11
June, 2019 EIR Siegfried AG - EIR, 2019-07-26
December, 2018 FDA 483 SEAWAY PHARMA - Form 483, 2018-12-10
November, 2016 FDA 483 Sandoz GmbH - Form 483, 2016-11-17
April, 2016 EIR Mylan Technologies Inc. - EIR, 2016-04-13
August, 2016 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2016-08-03
January, 2016 FDA 483 New England Home Therapies, Inc - Form 483, 2016-01-27
February, 2022 EIR Guardian Drug Company - EIR, 2022-02-17
November, 2010 FDA 483 Altaire Pharmaceuticals Inc. - Form 483, 2010-11-19
July, 2019 FDA 483 M Drug, LLC dba Northern Light Pharmacy - Form 483, 2019-08-20
December, 2022 FDA 483 Carbogen-Amcis AG - Form 483, 2022-12-16
December, 2017 FDA 483 Response AIRGAS USA, LLC - Form 483R, 2018-01-05
December, 2018 EIR SEAWAY PHARMA - EIR, 2018-12-10
December, 2022 FDA 483 Novartis Pharma Stein AG - Form 483, 2022-12-06
March, 2018 FDA 483 New England Life Care, Inc. - Form 483, 2018-03-02
October, 2011 EIR Mylan Technologies Inc. - EIR, 2011-10-31
January, 2024 FDA 483 Omega Laboratories Limited - Form 483, 2024-01-17
June, 2024 FDA 483 Hikma Injectables USA Inc. - Form 483, 2024-06-25
April, 2024 FDA 483 Bell-More Labs Inc - Form 483, 2024-04-03
May, 2016 FDA 483 Kumar Organic Products Limited - Form 483, 2016-05-13

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