FDA Investigator Sean R Marcsisin

Sean R Marcsisin has inspections in 11 countries as of 13 Oct 2023. Sean R Marcsisin has collaborated with a combinined 5967 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
75
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Germany, Norway, Canada, Israel, Finland, Poland, Sweden, Switzerland, Belgium, United Kingdom of Great Britain and Northern Ireland
Co-Investigator(s):
Abby E Pelletier, Adam R Cooke, Aditi S Thakur, Aimee Cunningham, PhD, Alan P Kurtzberg, Alan R Condon, Alice C Silva, Alison N Stieg, Allison A Aldridge, PhD, Amber G Wardwell, Amy C Jordan, Amy Devlin, PhD, Amy N Chen, Anastasia I Onuorah, Andrew M Barlow, Andrey Sarafanov, PhD, Anissa M Cheung, Anita R Michael, Ann L Demarco, Ann Marie Montemurro, Anne Carpenter, Anne E Carpenter, Annet R Rajan, Anthony C Warchut, Anthony J Ladner, Arie C Menachem, Arulvathani P Arudchandran, Atul J Agrawal, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara M Frazier, Bo Chi, PhD, Bogdan Kurtyka, Bradford L Swanson, Brandy N Lepage, Brenda P King, Brenda W Uratani, PhD, Brentley S Collins, Brently S Collins, Brian D Nicholson, Brooke K Higgins, Brooke K Seeman, Burnell M Henry, Calvin B Koerner, Camerson E Moore, Candace Y Gomez Broughton, Carolyn A Renshaw, Cassandra L Abellard, CDR Ileana Barreto Pettit, Celia N Cruz, Chaltu N Wakijra, Charanjeet Jassal, Charles R Cote, RIC, Chhaya S Shetty, Chris A Sack, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Christopher Downey, PhD, Christopher Janik, Chunchun Zhang, Constance Desimone, Courtney N Long, Craig T Rybus, Cynthia Jim, CSO, Dandan Wang, PhD, Daniel J Grabicki, Daniel L Zheng, Darin S Wiegers, Daryl A Dewoskin, David P Vanhouten, David Van Houten, Dawn M Braswell, Deborah J Parris, Dennis L Doupnik, Diane C Thibodeau, Diane T Bargo, Diane T O'brien, Diantha M Bleau, Dien N Nguyen, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Dorothy W Lee, Douglas A Campbell, Douglas Florentino, Dr. Robert C Horan, MD, Dr. Willie F Vann, PhD, Edmund F Mrak, Jr, Edward J Janik, Ekaterina Allen, Eliezar Ramos, Elizabeth Ll Edwards, Ellen Huang, Ellen P Madigan, Emest F Bizjak, Erik W Koester, Erin I Keith, Garry H Stewart, Gary J Hagan, Gene D Arcy, George J Flynn, George T Allen, Jr, Graeme E Price, Guerlain Ulysse, Gunther Bockhoudt, Gunther Boekhoudt, PhD, Hector A Carrero, Iraida Ortiz, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, James E Keller, PhD, James L Dunnie, Jr, James M Mason, James W Whitney, Janet A Rajan, Janet L Bowen, Jawaid Hamid, Jayaleka J Amarasinghe, Jee Chung, PhD, Jeffrey J Thibodeau, Jianming Li, Joan A Loreng, John A Sciacchitano, John P Mistler, John S Hartford, Johnna L Bleem, Jonah S Ufferfilge, Jonathan B Lewis, Jonathan G Matrisciano, Jonathan W Chapman, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose M Cayuela, Jose O Hernandez, Joseph H Procopio, Joyce A Rockwell, Juanita P Versace, Julie D Bringger, Justine M Corson, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Karen A Briggs, Karen Mcnabb Noon, Katelyn Astaub Zamperini, Kathleen E Mcafoose, Kathleen M Jordan, Kathleen R Jones, PhD, Kenneth H Williams, Kenneth M Gordon, Kent A Conforti, Kevin A Gonzalez, Kim Lthomas Cruse, Ko U Min, Kristen D Evans, Kristina L Conroy, Kshitij A Patkar, L Norwood, Lane V Christensen, PhD, Larry K Austin, Lauren N Barber, Laurie B Frazier, Laurie Graham, Lawrence J Stringer, LCDR Chad N Thompson, LCDR Debra Emerson, Leanna M Slarsky, Lei Zhang, PhD, Leiyun Boone, PhD, Leslie D Wagner, Lindsey R Lyman, Lori A Holmquist, Lori M Newman, Louis Christy, M Pedgen, Maotang Zhou, PhD, Marcus A Ray, Marea K Harmon, Margaret M Annes, Margaret M Sands, Maria Joselopez Barragan, PhD, Mariza M Jafary, Mark R Mcclain, Marlene G Swider, Martha T Olone, Martin J Guardia, Mary Jeanet Mcgarry, Massoud Motamed, Matthew D Silverman, Maxwell Van Tassell, PhD, Maya M Davis, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melissa J Garcia, Melissa T Roy, Michael A Charles, Michael P Sweeney, Michael R Goga, Michael S Araneta, Michael Schmitt, Michael Shanks, MS, Michele L Forster, PhD, Michele L Obert, Michelle M Noe, Michelle Marsh, Michelle Y Clark Stuart, Mihaly S Ligmond, Monica Commerford, PhD, Monica M Mcclure, Monique C Lo, Mra Mcculloughj, Mra Munizn, Nadeem I Chaudhry, Nailing Zhang, Nancy M Espinal, Nealie C Newberger, Nicholas A Violand, Nicholas L Paulin, Niketa Patel, Nirjal Bhattarai, Noreen Muniz, Obinna R Echeozo, Pamela L Ogonowski, Pankaj H Amin, Paraluman S Leonin, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul L Bellamy, Paul P Geraci, Paula A Trost, Paula J Bretz, Paula M Laplant, Pete Amin (Pankaj), Philip Kreiter, Phillip E Mclaughlin, Prabhu P Raju, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qin Xu, Rabin N Ghoshal, Rachael A Moliver, Ramon E Martinez, Ranjani Prabhakara, Rashmi Rawat, PhD, Raymond T Oji, Rebecca E Dombrowski, Reyes Candau Chacon, PhD, Richard E Needham, Richard H Penta, Richard J Friedman, Richard Ledwidge (nmi), PhD, Richard W Thornton, Robert D Ogan, Robert D Tollefsen, Robert J Doyle, Robert J Martin, Robert Mo Brien, Rochelle K Kimmel, Roger F Zabinski, Rory K Geyer, Rose M Ashley, Ruben C Ayala, PharmD, Russell J Glapion, Saied A Asbagh, Saleem A Akhtar, Samina S Khan, Samir C Gala, Samuel J Arsenault, Sandra A Hughes, Sandra P White, Sangeeta M Khurana, PhD, Satheesh Thomas, Scott R Nichols, PhD, Seth A Mailhot, Sharmista Chatterjee, Shirley S Wen, Sneha Patel, Sneha S Patel, Stacey S Degarmo, Stephen C Smith, Stephen D Brown, Stephen J Mottola, Stephen R Souza, Steve Y Rhieu, PhD, Steven Fong, MS, PhD, Steven M Weinman, Susan F Laska, MS, Susan M Jackson, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Tamara S Rosbury, Tamika White, Tamil Arasu, PhD, Tanya R Syffrard, Terry C Kimball, Thomas E Friel, Thomas J Arista, Thomas J Hudson, Thuy T Nguyen, LCDR, Tonia F Bernard, Toyin B Oladimeji, Uttaniti Limchumroon (Tom), Victor J Gangi, Victoria A Wagoner, Vidya B Pai, Vioela J Caze, Vipulchandr N Dholakia, Vipulchandra Dhalakia, Viviana Matta, Viviana R Ramirez, Walter Lange, Wayne E Seifert, William A Warnick, William Hallett, PhD, William J Leonard, William L Bargo, Xiaokuang Lai, PhD, Yanming An, PhD, Yetao Jin, PhD, Ying Xin Fan, PhD, Yong Hu, Yong Wang, Yvonne Y Wu, Zachary A Bogorad, Zhihao Qiu (Peter), PhD, Zhongren Wu, Ziyang Su, PhD

Sean R Marcsisin's Documents

Publish Date Document Type Title
July, 2023 FDA 483 Novo Nordisk US Bio Production Inc. - Form 483, 2023-07-25
July, 2022 FDA 483 Response Genzyme Corporation - Form 483R, 2022-08-08
May, 2018 FDA 483 Alnylam Pharmaceuticals Inc. - Form 483, 2018-05-04
May, 2017 FDA 483 Cambridge Isotope Laboratories, Inc. - Form 483, 2017-05-01
August, 2018 FDA 483 Pharmasol Corporation - Form 483, 2018-09-04
September, 2019 FDA 483 Flavour Speciality Ingredients Ltd - Form 483, 2019-09-24
January, 2019 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2019-01-18
September, 2016 FDA 483 Response Vertex Pharmaceuticals Incorporated - Form 483R, 2016-10-11
May, 2018 FDA 483 Response Alnylam Pharmaceuticals Inc. - Form 483R, 2018-05-18
June, 2019 FDA 483 Cardinal Health 414, LLC - Form 483, 2019-06-18
July, 2022 FDA 483 Genzyme Corporation - Form 483, 2022-07-25
March, 2019 FDA 483 AllerQuest LLC - Form 483, 2019-03-01
October, 2016 FDA 483 Tropical Products Inc - Form 483, 2016-10-14
December, 2018 FDA 483 Response Lyophilization Services Of New England, Inc. (LSNE) - Form 483R, 2018-12-30
February, 2018 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2018-02-01
November, 2021 FDA 483 Edge Pharma, LLC - Form 483, 2021-11-30
April, 2017 FDA 483 Matheson Tri-Gas, Inc. - Form 483, 2017-04-05
February, 2023 FDA 483 Denison Pharmaceuticals, LLC - Form 483, 2023-02-09
November, 2019 FDA 483 Tender Corporation - Form 483, 2019-11-25
July, 2021 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2021-07-28
September, 2018 FDA 483 Catalent Germany Schorndorf GmbH - Form 483, 2018-09-21
January, 2019 EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - EIR, 2019-01-18
September, 2023 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2023-09-27
November, 2019 FDA 483 Response Tender Corporation - Form 483R, 2019-12-17
April, 2019 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2019-04-19
November, 2017 FDA 483 Cambridge Isotope Laboratories, Inc. - Form 483, 2017-11-07
July, 2022 EIR Genzyme Corporation - EIR, 2022-07-25
June, 2021 FDA 483 Pharmasol Corporation - Form 483, 2021-06-14
March, 2017 FDA 483 MassBiologics - Form 483, 2017-03-09
May, 2019 FDA 483 N-Molecular, Inc. dba SOFIE - Form 483, 2019-05-16
September, 2017 FDA 483 Vertex Pharmaceuticals Incorporated - Form 483, 2017-09-07
June, 2021 FDA 483 Pharmasol Corporation - Form 483, 2021-06-14
May, 2022 FDA 483 Founders Science Group, LLC - Form 483, 2022-05-17
December, 2018 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2018-12-07
June, 2017 FDA 483 Charles River Laboratories, Inc. - Form 483, 2017-06-21
August, 2022 FDA 483 Lumene Oy - Form 483, 2022-08-26
May, 2017 FDA 483 Airgas Usa, LLC - Form 483, 2017-05-09
August, 2016 FDA 483 SRC Medical, Inc. - Form 483, 2016-08-03
July, 2022 FDA 483 Medical-technical Gases, Inc. - Form 483, 2022-07-08
December, 2018 FDA 483 Fresenius Kabi Compounding, LLC - Form 483, 2018-12-04
January, 2019 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2019-01-17
September, 2022 FDA 483 NextPharma Oy - Form 483, 2022-09-06
February, 2022 FDA 483 Pharmasol Corporation - Form 483, 2022-02-10
March, 2022 FDA 483 Wedgewood Village Pharmacy, LLC - Form 483, 2022-03-24
June, 2022 FDA 483 Airgas Usa, LLC - Form 483, 2022-06-08
January, 2020 FDA 483 Bristol-Myers Squibb Company - Form 483, 2020-01-10
October, 2019 FDA 483 Braintree Laboratories, Inc. - Form 483, 2019-10-22
February, 2018 FDA 483 N-Molecular, Inc. dba SOFIE - Form 483, 2018-02-28
July, 2019 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2019-07-25
December, 2018 EIR Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2018-12-07
April, 2017 FDA 483 Bristol-Myers Squibb Company - Form 483, 2017-04-05
March, 2023 FDA 483 Safecor Health, LLC - Form 483, 2023-03-16
November, 2023 FDA 483 Hikma Pharmaceuticals USA Inc. - Form 483, 2023-11-22
December, 2023 FDA 483 Bolger O'Hearn Inc. - Form 483, 2023-12-19

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