FDA Investigator Steven E Bowen, PhD

Steven E Bowen, PhD has conducted inspections on 16 sites in 5 countries as of 24 Feb 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
16
Last Inspection Date:
24 Feb 2022
Investigator Role:
FDA Investigator
Redica ID:
100007117
Countries of Inspections:
Israel, China, United States of America, Japan, Puerto Rico
FDA Investigators that have inspected at least one site in common with Steven E Bowen, PhD:
Alice S Tsao, Amy Devlin, PhD, Anastasia G Lolas, Andrea Siegel, PhD, Andrew Byrnes, PhD, Angela S Whatley, Anjali Shukla, PhD, Ann Marie Montemurro, Ann Marie Schofield, Anna R Kwilas, Arie C Menachem, Arsen Karapetyan, Benjamin J Smith, Bo Chi, PhD, Brentley S Collins, Brian M Janelsins, PhD, Brooke K Higgins, Brooke K Seeman, Burnell M Henry, CDR Cecily Jones, CDR Donald Ertel, Chaltu Nwakijra, Chava Kimchi Sarfaty, PhD, Christian D Lynch (CDL), Christopher T Middendorf, Claire M Minden, Colleen Thomas, PhD, Cynthia Jim, CSO, Daniel L Aisen, Deborah M Trout, Destry M Sillivan, Donald C Obenhuber, PhD, Douglas A Campbell, Dr. Jun Liu, PhD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Emest F Bizjak, Frances Namuswe, PhD, Gene D Arcy, Geneve M Maxwell, Geneve M Parks, Harry J Brewer, Howard Anderson, PhD, Ivis L Negron, Jacqueline Mdiaz Albertini, Jakob Reiser, PhD, Jason D Abel, Jazmine N Still, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jennifer Swisher, PhD, Joanne M Schlossin, Joel R Merriman, Jonathan W Chapman, Jose Acruz Gonzalez, José E Meléndez, Kalavati Suvarna, PhD, Karen L Kosar, Karlton T Watson, Kathy Lee, Kevin A Gonzalez, Lakshmi Narasimhan, PhD, Larry K Austin, Lauren M Lilly, PhD, Lewis K Antwi, Libia M Lugo, Lilia Bi, PhD, Linda Thai, Lisa L Flores, LT Richard A Lyght, Madushini Dharmasena, PhD, Maria Gutierrez Lugo, PhD, Marion Michaelis, Marla A Cassidy, Mary E Farbman, PhD, Meisha R Sampson, Meisha Waters, Mekonnen Lemma Dechassa, PhD, Melissa J Garcia, Michael E Maselli, Michael G Truchan, Michael Havert, PhD, Michael Shanks, MS, Michael W Burd, Michele L Forster, PhD, Michele Perry Williams, Michelle Yclark Stuart, Mihaly S Ligmond, Morris Sheldon, PhD, Muna Algharibeh, Nebil A Oumer, Nirjal Bhattarai, Noreen Muñiz, Pankaj K Mandal, Paula A Trost, Phillip C Thai, Prabhu P Raju, Priscilla M Pastrana, Rabia Ballica, PhD, Rachel C Harrington, Ramesh Potla, PhD, Ramjay Vatsan, PhD, Randa Melhem, PhD, Raquel Gonzalez Rivera, Rebecca E Dombrowski, Rebecca Rodriguez, Richard Ledwidge (nmi), PhD, Robert Jennings, Robert M Barbosa, Roger F Zabinski, Rose Ashley, Sarah E Rhoades, Scott R Nichols, PhD, Scott T Ballard, Shadia Zaman, PhD, Sharon K Thoma, PharmD, Sheldon Morris, Sidney B Priesmeyer, Steven Fong, MS, PhD, Tammy S Notto, Teegan Dellibovi Ragheb, PhD, Thai D Truong, Thuy T Nguyen, LCDR, Wei Wang, PhD, Wendy G Tan, PhD, Wendy M Stone, Xiaoshi N Wang, Zenobia Taraporewala, Zhenzhen Liu, PhD

Steven E Bowen, PhD's Documents

Publish Date Document Type Title
February, 2020 FDA 483 OMRIX BIOPHARMACEUTICALS LTD - Form 483, 2020-02-24
February, 2021 FDA 483 Brammer Bio MA, LLC - Form 483, 2021-02-10
December, 2020 EIR Lonza Houston, Inc - EIR, 2020-12-10
April, 2016 EIR Human Genome Sciences, Inc. - EIR, 2016-04-11
July, 2021 FDA 483 Haematologic Technologies, LLC dba Prolytix - Form 483, 2021-07-30
February, 2021 FDA 483 Brammer Bio MA, LLC - Form 483, 2021-02-10
December, 2020 FDA 483 Response Lonza Houston, Inc - Form 483R, 2020-12-18
June, 2021 EIR Novartis Gene Therapies, Inc. - EIR, 2021-06-16
July, 2019 FDA 483 TOYOBO CO., LTD. - Form 483, 2019-07-30
September, 2019 FDA 483 SAFC Carlsbad Inc. - Form 483, 2019-09-12
February, 2021 EIR Brammer Bio MA, LLC - EIR, 2021-02-10
August, 2017 FDA 483 WuXi Biologics Co., Ltd. - Form 483, 2017-08-02
June, 2021 FDA 483 Response Novartis Gene Therapies, Inc. - Form 483R, 2021-07-09
September, 2019 EIR SAFC Carlsbad Inc. - EIR, 2019-09-12
May, 2018 FDA 483 Exelead, Inc. - Form 483, 2018-05-15
March, 2022 FDA 483 Spark Therapeutics, Inc. - Form 483, 2022-03-04
January, 2020 FDA 483 Merck Teknika LLC - Form 483, 2020-01-24
January, 2017 EIR AbbVie Biotechnology LTD - EIR, 2017-01-13
June, 2021 FDA 483 Novartis Gene Therapies, Inc. - Form 483, 2021-06-16
December, 2020 FDA 483 Lonza Houston, Inc - Form 483, 2020-12-10

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