FDA Investigator Richard Ledwidge (nmi), PhD

Richard Ledwidge (nmi), PhD has conducted inspections on 31 sites in 14 countries as of 30 Nov 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
31
Last Inspection Date:
30 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Ireland, Malaysia, France, Italy, United States of America, Korea (Republic of), Israel, Switzerland, Iceland, Spain, Germany, China, Austria, Taiwan
FDA Investigators that have inspected at least one site in common with Richard Ledwidge (nmi), PhD:
Adam R Cooke, Adetutu M Gidado, Alan L Truong, Alice S Tsao, Amy C Jordan, Amy Devlin, PhD, Amy N Chen, Anastasia G Lolas, Andrea Siegel, PhD, Andrew "Drew" Haack, PhD, Andrew J Barrowcliff, Andrew K Haack, PhD, Anh M Lac, Anita Narula, PhD, Anita R Michael, Anjali Shukla, PhD, Ann L Demarco, Ann Marie Montemurro, Arie C Menachem, Ariel Cruz Figueroa, Arsen Karapetyan, Arulvathani P Arudchandran, Ashar P Parikh, Azza Talaat, Barbara Janine Breithaupt, Bijoy Panicker, Bingchen Du, PhD, Bo Chi, PhD, Brandy N Lepage, Brenda W Uratani, PhD, Brian A Roelofs, Brian M Janelsins, PhD, Brooke K Higgins, Burnell M Henry, Calvin B Koerner, Candace Y Gomez Broughton, Carl A Huffman, III, Carolyn A Renshaw, Caryn M Mcnab, CDR Donald Ertel, Chaltu Nwakijra, Charisse K Green, Charles Yuanchia Kuo, PhD, Chava Kimchi Sarfaty, PhD, Chen Sun, PhD, Cheryl A Clausen, Chiang Syin, PhD, Christopher Downey, PhD, Christopher R Czajka, Colleen F Hoyt, Concepcion Cruz, Jr, Cynthia Jim, CSO, Daniel J Lahar, Daniel J Roberts, Daryl A Dewoskin, David M Beltran, Deborah M Trout, Debra J Bennett, Denise M Digiulio, Dennis Cantellops Paite, Devaughn Edwards, Diane Kelley, Diane L Raccasi, Dien N Nguyen, Dilip Devineni, PhD, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Donald C Obenhuber, PhD, Donna Ltartaglino Besone, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie Wilson, PhD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Eileen A Liu, Eliezar Ramos, Emily J Orban, Ephrem Hunde, PhD, Eric M Mueller, PharmD, Erika V Butler, Erin D Mccaffery, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Gerald B Seaborn, Jr, Guerlain Ulysse, Gwyn G Dickinson, Hamet M Toure, PharmD MPH, Hao Kiet D Phan, Haoheng Yan, PhD, Helen B Ricalde, Holly Brevig, Hyung Yul Lee, Ian L Mcwilliams, Ivis L Negron, J Paul Kirwan, PhD, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, James A Beaulieu, James C Maclaughlin, Janete F Guardia, Javier E Santos, Jay T Wong, Jeanne Fringer, PhD, Jee Chung, PhD, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer Swisher, PhD, Jens Fricke, Jessica Hankins, PhD, Jessica L Pressley, Jill J Tillman, Jing Fang, Joan Johnson, Joey V Quitania, John D White, Jonathan W Chapman, Jose Acruz Gonzalez, José E Meléndez, Joseph A Piechocki, Joseph R Lambert, Joseph R Strelnik, Joshua J Silvestri, Joslyn K Brunelle, PhD, Julie D Bringger, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Karen A Briggs, Katherine D Adams, Katherine Szestypalow, Kathleen R Jones, PhD, Kathryn E King, Kathy Lee, Kenneth G Klobus, Kevin A Gonzalez, Kham Phommachanh, Kristin M Abaonza, Kristy A Zielny, Kshitij A Patkar, Kurt A Brorson, PhD, Lakshmi Narasimhan, PhD, Lance Mde Souza, MBA, Larry K Austin, Laura Fontan, MS, Lauren N Howard, Laurie Graham, LCDR Chad N Thompson, Lei Zhang, PhD, Leiyun Boone, PhD, Leonard H Lavi, Linda F Murphy, Linda Thai, Lisa K Capron, Lori J Silverstein, LT Richard A Lyght, Lynda L Perry, PhD, Madushini Dharmasena, PhD, Marcus F Yambot, Margaret E Sarles, Maria Cecilia Tami, PhD, Maria Cruz Fisher, Maria Gutierrez Hoffman, PhD, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Mariza M Jafary, Mark Brunswick, PhD, Mark R Mcclain, Marlene G Swider, Marvin D Jones, Mary E Farbman, PhD, Mary E Storch, Maryam Tabatabaie, Massod Rahimi, PhD, Matthew B Casale, Maxwell Van Tassell, PhD, Megan A Haggerty, Melissa D Ray, Melissa J Garcia, Michael A Charles, Michael E Maselli, Michael R Goga, Michael S Araneta, Michael Shanks, MS, Michele L Glendenning, Michele Perry Williams, Michelle Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milos Dokmanovic, PhD, Mindy M Chou, Monica Commerford, PhD, Monica E Caphart, Monica E Murie, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Nataniel Phillips Sylvain, PhD, Nealie C Newberger, Nebil A Oumer, Nibin Varghese, MS, Nicholas L Hunt, Noreen Muñiz, Ogechi C Nna, Omotunde O Osunsanmi, Pankaj H Amin, Patricia D Stahnke, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patty P Kaewussdangkul, Paul L Figarole, Jr, Paul Mouris, Peter Adams, PhD, Peter E Baker, Prabhu P Raju, Prajakta A Varadkar, Qing Joanna Zhou, PhD, Rabia Ballica, PhD, Rachel C Harrington, Rajiv R Srivastava, Ram Sihag, PhD, Raquel Gonzalez Rivera, Rebecca E Dombrowski, Rebecca Rodriguez, Reyes Candau Chacon, PhD, Richard K Vogel, Richard W Berning, Riley C Myers, PhD, Robert D Tollefsen, Robert J Ham, Robert J Martin, Robert Jennings, Rochelle K Kimmel, Roger F Zabinski, Ronald G Crawford, Rong Guo, Rong Wang, PhD, Rose Ashley, Roy R Rinc, Russell J Glapion, S Lori Brown, PhD MPH, Saleem A Akhtar, Sandra A Hughes, Sang Bong Lee, Santos E Camara, Sara H Gabel, Sarah Kennett, PhD, Scott C Lute, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Shadia Zaman, PhD, Shawn E Larson, Shirley J Berryman, Sidney B Priesmeyer, Simone E Pitts, Sony Mathews, Stacey S Degarmo, Steven D Kehoe, Steven E Bowen, PhD, Steven E Kane, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Stuart W Russell, Susan F Laska, MS, Susan M Jackson, Susan T Hadman, Tamil Arasu, PhD, Tara L Greene, Tara L King, Teegan Dellibovi Ragheb, PhD, Temar Q Williams, Thomas J Arista, Thuy T Nguyen, LCDR, Tracy Denison, PhD, Tricia S Martinez, Tzanko Stantchev, V Teres Speer, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Veronica Fuentes, MS, Victor J Gangi, Vidya B Pai, Virgilio F Pacio, CSO, Viviana Matta, Walter N Lange, Warren J Lopicka, Wayne E Seifert, Wendy G Tan, PhD, William Hallett, PhD, William V Millar, Xiaoshi N Wang, Xu Michael Di, PhD, Yanming An, PhD, Yetao Jin, PhD, Yideng Liang, Ying Xin Fan, PhD, Yiwei Li, Yongmin Liu, Yuan Chia Kuo, Yun Wu, PhD, Zerita White, Zhang Zhao, PhD, Zhong Li, PhD, Zhong Zhao, PhD, Ziyang Su, PhD

Richard Ledwidge (nmi), PhD's Documents

Publish Date Document Type Title
November, 2020 FDA 483 Response AGC Biologics, Inc. - Form 483R, 2020-11-23
July, 2018 EIR CELLTRION Inc - EIR, 2018-07-17
December, 2021 EIR Immunex Rhode Island Corporation - EIR, 2021-12-07
May, 2022 FDA 483 Merck Biodevelopment - Form 483, 2022-05-24
April, 2016 EIR Human Genome Sciences, Inc. - EIR, 2016-04-11
April, 2017 FDA 483 Boehringer Ingelheim Fremont, Inc. - Form 483, 2017-04-04
December, 2021 FDA 483 Response Immunex Rhode Island Corporation - Form 483R, 2021-12-20
July, 2019 FDA 483 Bio-Technology General (Israel) Ltd. - Form 483, 2019-07-11
February, 2009 FDA 483 Bayer Healthcare Pharmaceuticals, Inc - Form 483, 2009-02-05
March, 2018 FDA 483 Eli Lilly Kinsale Limited - Form 483, 2018-03-16
June, 2021 EIR Hanmi Pharm. Co., Ltd. - EIR, 2021-06-02
July, 2018 FDA 483 CELLTRION Inc - Form 483, 2018-07-17
November, 2020 EIR AGC Biologics, Inc. - EIR, 2020-11-02
November, 2018 EIR Boehringer Ingelheim RCV GmbH & Co KG - EIR, 2018-11-23
February, 2009 EIR Bayer Healthcare Pharmaceuticals, Inc - EIR, 2009-02-05
April, 2015 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2015-04-03
March, 2023 FDA 483 Alvotech Hf - Form 483, 2023-03-17
September, 2023 FDA 483 Fournier Laboratories Ireland Limited - Form 483, 2023-09-12
June, 2021 FDA 483 Hanmi Pharm. Co., Ltd. - Form 483, 2021-06-02
December, 2021 FDA 483 Immunex Rhode Island Corporation - Form 483, 2021-12-07
November, 2018 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2018-11-23
November, 2020 FDA 483 AGC Biologics, Inc. - Form 483, 2020-11-02
January, 2023 FDA 483 Patheon Biologics LLC - Form 483, 2023-01-24
August, 2022 FDA 483 BIOCON SDN.BHD. - Form 483, 2022-08-30
February, 2009 FDA 483 Response Bayer Healthcare Pharmaceuticals, Inc - Form 483R, 2009-02-27
July, 2024 FDA 483 Biocon Biologics Limited - Form 483, 2024-07-26
December, 2023 FDA 483 Suzhou Suncadia Biopharmaceuticals Co., Ltd - Form 483, 2023-12-14
February, 2024 FDA 483 Hugel, Inc. - Form 483, 2024-02-01
December, 2023 EIR Suzhou Suncadia Biopharmaceuticals Co., Ltd - EIR, 2024-07-16
September, 2023 FDA 483 Patheon Italia S.p.A. - Form 483, 2023-09-05

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