FDA Investigator Sean R Marcsisin

Sean R Marcsisin has conducted inspections on 81 sites in 12 countries as of 13 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
81
Last Inspection Date:
13 May 2024
Investigator Role:
FDA Investigator
Redica ID:
100002238
Countries of Inspections:
United States of America, Belgium, United Kingdom of Great Britain and Northern Ireland, India, Sweden, Finland, Canada, Israel, Norway, Germany, Switzerland, Poland
FDA Investigators that have inspected at least one site in common with Sean R Marcsisin:
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 E Carpenter, Annet R Rajan, Anthony C Warchut, Anthony J Ladner, Arie C Menachem, Armen H Youssoufian, Arulvathani P Arudchandran, Atul J Agrawal, Azeezat M Lawal, 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, 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, CDR Jeremy L Wally, PhD, Celia N Cruz, Chaltu Nwakijra, Charanjeet Jassal, Charles R Cote, RIC, Chhaya S Shetty, Chris A Sack, Christian D Lynch (CDL), Christian F Gomez Lugo, Christina Capacci Daniel, PhD, Christina K Theodorou, 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 A Oluwo, David P Vanhouten, Dawn M Braswell, Deborah J Parris, Debra I Love, Dennis L Doupnik, Devon Jenkins, Diane C Thibodeau, Diane T Bargo, Diane T O'brien, Diantha M Bleau, Dien N Nguyen, Divek R Jumani, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Dorothy W Lee, Douglas A Campbell, Dr. Erika A Pfeiler, Dr. Robert C Horan, MD, Dr. S Nar Ali, PhD, Dr. Willie F Vann, PhD, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Edward J Janik, Eileen A Liu, Ekaterina Allen, Eliezar Ramos, Elizabeth Ll Edwards, Ellen Huang, Ellen P Madigan, Emest F Bizjak, Erika V Butler, Erin I Keith, Felix Maldonado, Frederick F Razzaghi, Garry H Stewart, Gary J Hagan, Gene D Arcy, George J Flynn, George T Allen, Jr, Graeme E Price, Graeme Price, Guerlain Ulysse, Gunther Boekhoudt, PhD, Hasan A Irier, 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 Gonzalez, 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, José E Meléndez, Jose M Cayuela, Jose Ohernandez Guzman, Joseph H Procopio, Jr, Joy Rkozlowski Klena, Joyce A Rockwell, Juanita P Versace, Julie D Bringger, Justine M Corson, Justine Tomasso, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Karen A Briggs, Karen E D'orazio, Karen Mcnabb Noon, Karishma G Gopaul, Katelyn Astaub Zamperini, Katherine Szestypalow, Kathleen E Mcafoose, Kathleen M Jordan, Kathleen R Jones, PhD, Kenneth H Williams, Kenneth M Gordon, Kent A Conforti, Kevin A Gonzalez, Kham Phommachanh, Kim Lthomas Cruse, Ko U Min, Kristen D Evans, Kristina L Conroy, Krystyna M Kitson, 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, Lewis K Antwi, Lindsey R Lyman, Loretta Nemchik, 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 B Casale, 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 Varga, Michelle Marsh, Michelle Yclark 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 Muñiz, Obinna R Echeozo, Ogechi C Nna, Pamela L Ogonowski, Pankaj H Amin, Paraluman S Leonin, Patricia F Hughes, PhD, 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 L Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard W Thornton, Robert D Ogan, Robert D Tollefsen, Robert J Doyle, Robert J Martin, Robert O'brian, Rochelle K Kimmel, Rochelle L Cross, Roger F Zabinski, Rory K Geyer, Rosario D'costa, Rose 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 S Patel, Sony Mathews, 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, Susanne M Richardson, MS RAC, Svetlana A Shestopal, Syed N Ali, Taichun Qin, PhD, 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, Vijaya L Simhadri, Vioela J Caze, Vipulchandra N Dholakia, Viviana Matta, Viviana R Ramirez, Walter N 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, Yoriann M Cabrera Bartolomei, Yvesna C Blaise, Yvins Dezan, Yvonne Y Wu, Zachary A Bogorad, Zhongren Wu, Ziyang Su, PhD

Sean R Marcsisin's Documents

Publish Date Document Type Title
April, 2024 FDA 483 Cipla Ltd. - Form 483, 2024-04-04
April, 2017 FDA 483 Matheson Tri-Gas, Inc. - Form 483, 2017-04-05
November, 2017 FDA 483 Cambridge Isotope Laboratories, Inc. - Form 483, 2017-11-07
June, 2017 FDA 483 Charles River Laboratories, Inc. - Form 483, 2017-06-21
May, 2022 FDA 483 Founders Science Group, LLC - Form 483, 2022-05-17
August, 2022 FDA 483 Lumene Oy - Form 483, 2022-08-26
October, 2019 FDA 483 Braintree Laboratories, Inc. - Form 483, 2019-10-22
July, 2021 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2021-07-28
November, 2019 FDA 483 Tender Corporation - Form 483, 2019-11-25
May, 2019 FDA 483 N-Molecular, Inc. dba SOFIE - Form 483, 2019-05-16
May, 2017 FDA 483 AIRGAS USA, LLC - Form 483, 2017-05-09
January, 2019 EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - EIR, 2019-01-18
March, 2017 FDA 483 MassBiologics - Form 483, 2017-03-09
November, 2021 FDA 483 Edge Pharma, LLC - Form 483, 2021-11-30
March, 2022 FDA 483 Wedgewood Village Pharmacy, LLC - Form 483, 2022-03-24
December, 2018 FDA 483 Response Lyophilization Services Of New England, Inc. (LSNE) - Form 483R, 2018-12-30
April, 2019 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2019-04-19
September, 2022 FDA 483 NextPharma Oy - Form 483, 2022-09-06
May, 2023 FDA 483 Teva Pharmaceutical Industries Ltd. - Form 483, 2023-05-23
May, 2018 FDA 483 Response Alnylam Pharmaceuticals Inc. - Form 483R, 2018-05-18
July, 2023 FDA 483 Novo Nordisk US Bio Production Inc. - Form 483, 2023-07-25
July, 2022 EIR Genzyme Corporation - EIR, 2022-07-25
February, 2023 FDA 483 Denison Pharmaceuticals, LLC - Form 483, 2023-02-09
February, 2018 FDA 483 Shire Human Genetic Therapies, Inc. - Form 483, 2018-02-01
October, 2016 FDA 483 Tropical Products Inc - Form 483, 2016-10-14
December, 2023 FDA 483 Bolger O'Hearn Inc. - Form 483, 2023-12-19
September, 2018 FDA 483 Catalent Germany Schorndorf GmbH - Form 483, 2018-09-21
February, 2022 FDA 483 Pharmasol Corporation - Form 483, 2022-02-10
November, 2019 FDA 483 Response Tender Corporation - Form 483R, 2019-12-17
March, 2019 FDA 483 ALK-ABELLO, INC. - Form 483, 2019-03-01
March, 2024 FDA 483 Zydus Lifesciences Limited - Form 483, 2024-03-27
July, 2022 FDA 483 Genzyme Corporation - Form 483, 2022-07-25
June, 2021 FDA 483 Pharmasol Corporation - Form 483, 2021-06-14
July, 2022 FDA 483 Response Genzyme Corporation - Form 483R, 2022-08-08
September, 2023 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2023-09-27
July, 2022 FDA 483 Medical-technical Gases, Inc. - Form 483, 2022-07-08
August, 2018 FDA 483 Pharmasol Corporation - Form 483, 2018-09-04
January, 2020 FDA 483 Bristol-Myers Squibb Company - Form 483, 2020-01-10
September, 2019 FDA 483 Flavour Speciality Ingredients Ltd - Form 483, 2019-09-24
June, 2019 FDA 483 Cardinal Health 414, LLC - Form 483, 2019-06-18
January, 2019 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2019-01-18
May, 2017 FDA 483 Cambridge Isotope Laboratories, Inc. - Form 483, 2017-05-01
May, 2018 FDA 483 Alnylam Pharmaceuticals Inc. - Form 483, 2018-05-04
June, 2021 FDA 483 Pharmasol Corporation - Form 483, 2021-06-14
February, 2024 FDA 483 EyePoint Pharmaceuticals US, Inc. - Form 483, 2024-02-15
July, 2019 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2019-07-25
April, 2017 FDA 483 Bristol-Myers Squibb Company - Form 483, 2017-04-05
December, 2018 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2018-12-07
November, 2023 FDA 483 Hikma Pharmaceuticals USA Inc. - Form 483, 2023-11-22
June, 2022 FDA 483 AIRGAS USA, LLC - Form 483, 2022-06-08
August, 2016 FDA 483 SRC Medical, Inc. - Form 483, 2016-08-03
September, 2016 FDA 483 Response Vertex Pharmaceuticals Incorporated - Form 483R, 2016-10-11
January, 2019 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2019-01-17
February, 2018 FDA 483 N-Molecular, Inc. dba SOFIE - Form 483, 2018-02-28
January, 2024 FDA 483 PS-Connections, LLC - Form 483, 2024-01-18
March, 2023 FDA 483 Safecor Health, LLC - Form 483, 2023-03-16
September, 2017 FDA 483 Vertex Pharmaceuticals Incorporated - Form 483, 2017-09-07
December, 2018 FDA 483 Fresenius Kabi Compounding, LLC - Form 483, 2018-12-04
December, 2018 EIR Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2018-12-07
May, 2024 FDA 483 Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2024-05-24
September, 2021 FDA 483 EyePoint Pharmaceuticals US, Inc. - Form 483, 2021-09-01
July, 2024 FDA 483 Genzyme Corporation - Form 483, 2024-07-09

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