FDA Investigator Madushini Dharmasena, PhD

Madushini Dharmasena, PhD has inspections in 12 countries as of 12 Oct 2023. Madushini Dharmasena, PhD has collaborated with a combinined 3046 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
15
Last Inspection Date:
12 Oct 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
100002730
Country:
Ireland, Singapore, Japan, Belgium, United States of America, Iceland, Netherlands, Korea (Republic of), Switzerland, Israel, India
Co-Investigator(s):
Alice S Tsao, Alicia M Mozzachio, Amy Devlin, PhD, Anastasia G Lolas, Andrea Siegel, PhD, Anissa M Vargas, Anita Narula, PhD, Anjali Shukla, PhD, Ann Marie Montemurro, Anthony A Charity, Arnold Seo, PhD, Arsen Karapetyan, Ashutosh Rao, PhD, Azza Talaat, Barbara J Rincon, Bijoy Panicker, Bo Chi, PhD, Brandon C Heitmeier, Brooke K Higgins, Candace Y Gomez Broughton, Carla J Lundi, CDR Donald Ertel, Chaltu N Wakijra, Charisse K Green, Chen Sun, PhD, Chikako Torgioe, Cynthia Jim, CSO, David Doteski, Deborah Schmiel, PhD, Dennis Cantellops Paite, Diane L Raccasi, Dogbeda F Mackenzie, Donald C Obenhuber, PhD, Dr. Jun Liu, PhD, Dr. Ralph M Bernstein, PhD, Ephrem Hunde, PhD, Erika V Butler, Frances Namuswe, PhD, Gerald B Seaborn, Jr, Guerlain Ulysse, Gunther Boekhoudt, PhD, Hamet M Toure, PharmD MPH, Hamet Toure, PharmD MPH, Herbert M Corbello, Hyung Yul Lee, Ivis L Negrón, Ivis Lnegron Torres, J David Doleski, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, Jee Chung, PhD, Jeffrey P Raimondi, Jennifer Swisher, PhD, Joanne M Schlossin, John F Cipollo, Jon Park, Jonathan W Chapman, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose E Melendez, DDC, Juhong Liu, PhD, Justin A Boyd, Kalavati Suvarna, PhD, Katherine Szestypalow, Kathy Lee, Kelly R Lewis, Kent C Faul, Kevin A Gonzalez, Larry K Austin, Laura Fontan, MS, Laurel A Beer, Lei Zhang, PhD, Leonard H Lavi, Libia M Lugo, Linda Thai, Lindsey S Fleischman, Lixin Xu, MD, PhD, Lori J Silverstein, LT Richard A Lyght, Lucila B Nwatu, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marion Michaelis, Mary E Farbman, PhD, Mary E Storch, Maryam Tabatabaie, Matthew B Casale, Mekonnen Lemma Dechassa, PhD, Meredith P Soehl, Investigator, Michael A Charles, Michael Shanks, MS, Michele L Obert, Mihaly S Ligmond, Monica Markovski, PhD, Mra Mcculloughj, Nadeem I Chaudhry, Nancy A Bellamy, Nancy G Schmidt, Nancy T Waites, Nebil A Oumer, Omotunde O Osunsanmi, Patricia Fhughes Troost, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick J Lynch, Patsy J Domingo, Paula A Trost, Peter R Lenahan, Phillip Angart, PhD, Prabhu P Raju, Rachel C Harrington, Rajiv R Srivastava, Ramesh Potla, PhD, Rebecca Rodriguez, Reyes Candau Chacon, PhD, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Robert D Tollefsen, Robert J Ham, Robert Rodriguez, Roger F Zabinski, Rose M Ashley, Santos E Camara, Sarah Arden, Sarah Johnson, PhD, Sarah Kennett, PhD, Scott E Norris, Scott R Nichols, PhD, Seifert Seifert, Wayne E, Shadia Zaman, PhD, Simone E Pitts, Stephen D Brown, Steven E Bowen, PhD, Steven E Kane, Steven Fong, MS, PhD, Steven M Weinman, Susan M Jackson, Susan P Bruederle, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, Thuy Y Nguyen, Tiara Nbrown Crosen, Tina S Roecklein, Tracey L Harris, Uduak M Inokon, Vaishali J Patel, Virginia Carroll, PhD, Viviana Matta, Wayne E Seifert, William Hallett, PhD, Willie Wilson, Xiaokuang Lai, PhD, Xiaoshi Wang, Yanming An, PhD, Yetao Jin, PhD, Ying Xin Fan, PhD, Yun Wu, PhD, Zabinski Zabinski, Roger F, Zhihao Qiu (Peter), PhD, Zhong Li, PhD

Madushini Dharmasena, PhD's Documents

Publish Date Document Type Title
April, 2023 FDA 483 UCB Pharma S.A. - Form 483, 2023-04-21
August, 2021 FDA 483 Hugel, Inc. - Form 483, 2021-08-20
June, 2019 FDA 483 Lonza Biologics Tuas Pte Ltd. - Form 483, 2019-06-18
June, 2022 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2022-06-09
March, 2022 FDA 483 Alvotech Hf - Form 483, 2022-03-22
November, 2022 FDA 483 Byondis B.V. - Form 483, 2022-11-10
August, 2018 FDA 483 Response Immunomedics, Inc. - Form 483R, 2018-09-04
August, 2018 EIR Immunomedics, Inc. - EIR, 2018-08-14
October, 2019 FDA 483 Lonza AG - Form 483, 2019-10-18
March, 2019 FDA 483 Human Genome Sciences, Inc. - Form 483, 2019-03-15
October, 2019 FDA 483 Kyowa Kirin Co., Ltd. - Form 483, 2019-10-04
August, 2018 FDA 483 Immunomedics, Inc. - Form 483, 2018-08-14
August, 2021 EIR Hugel, Inc. - EIR, 2021-08-20
May, 2023 FDA 483 Pfizer Ireland Pharmaceuticals - Form 483, 2023-05-11
June, 2019 EIR Lonza Biologics Tuas Pte Ltd. - EIR, 2019-07-09
April, 2023 EIR UCB Pharma S.A. - EIR, 2023-07-28

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