FDA Investigator Dr. Ralph M Bernstein, PhD

Dr. Ralph M Bernstein, PhD has conducted inspections on 28 sites in 11 countries as of 19 Feb 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
28
Last Inspection Date:
19 Feb 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, India, United Kingdom of Great Britain and Northern Ireland, Korea (Republic of), Japan, Singapore, Germany, Switzerland, Austria, Ireland, Denmark
FDA Investigators that have inspected at least one site in common with Dr. Ralph M Bernstein, PhD:
Abdur Razzaque, Adam R Cooke, Aditi S Thakur, Aimee Cunningham, PhD, Alan M Roberts, Alicia M Mozzachio, Anastasia G Lolas, Anastasia M Shields, Andrea A Branche, Andrea Franco, Andrea George, PhD, Angel K Sandhu, Anh M Lac, Anita Narula, PhD, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, April L Brown, April L Young, Arie C Menachem, Arsen Karapetyan, Ashar P Parikh, Ashutosh Rao, PhD, Azza Talaat, Barbara J Wilcox, PhD, Barbara Janine Breithaupt, Barbara M Frazier, Bazarragchaa Damdinsuren, PhD, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brenda W Uratani, PhD, Brentley S Collins, Brian M Janelsins, PhD, Brooke K Higgins, Bruce Huang, Burnell M Henry, Calvin B Koerner, Carl Lee, Carole L Jones, Carolyn A Renshaw, Caryn M Mcnab, CDR Jeremy L Wally, PhD, CDR Rochelle B Young, RPh, MSA, CDR Thomas R Berry, PPh, Charles R Cote, RIC, Chiang Syin, PhD, Christian D Lynch (CDL), Christina V Santos, Christine M Parmentier, Christopher Downey, PhD, Christopher R Czajka, Christos G Tsingelis, Concepcion Cruz, Jr, Cynthia Jim, CSO, Daniel J Roberts, Deborah Schmiel, PhD, Dennis Cantellops Paite, Devaughn Edwards, Diane L Raccasi, Dianne S Alexander, Djamila Harouaka, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Donald C Obenhuber, PhD, Douglas A Campbell, Dr. Barbara D Paul, PhD, Dr. Guang Gao, PhD, Dr. Jun Liu, PhD, Dr. Mark J Seaton, PhD, Dr. Zhihao Qiu (Peter), PhD, Dustin R Abaonza, Eileen A Liu, Eliezar Ramos, Emest F Bizjak, Emily Shacter, Ephrem Hunde, PhD, Eric L Dong, BS, Erika V Butler, Erin L Mcfiren, Felix Maldonado, Frances Namuswe, PhD, Gene D Arcy, Genoula K Ryan, Gerald B Seaborn, Jr, Gerald Feldman, Gerald M Feldman, PhD, Gilbert T Salud, Ginger M Sykes, Gregory W Smith, Guerlain Ulysse, Hai Lient Phung, Hao Kiet D Phan, Haoheng Yan, PhD, Helen B Ricalde, Henry K Lau, Herbert M Corbello, Holly Brevig, Howard Anderson, PhD, Hyung Yul Lee, Ibad U Khan, Ivis L Negron, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, James R Evans, Jamie L Dion, Jason F Chancey, Jeanne Fringer, PhD, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer Lalama, Jennifer M Gogley, Jennifer Swisher, PhD, Jessica L Pressley, Jie He, Joan A Loreng, Joan T Briones, Joanne E King, Joel D Martinez, Joel Welch, PhD, Joey V Quitania, John D White, Jolanna A Norton, Jonathan W Chapman, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose M Cayuela, Jose M Melendez, Joseph F Owens, Joseph Kutze, PhD, Joseph P Iser, MD, Joshua S Hunt, Juan Rjimenez Garcia, Juhong Liu, PhD, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Karen E D'orazio, Katherine Szestypalow, Kathleen R Jones, PhD, Kayla V Sprague, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kirsten L Vadheim, PhD, Kristen Nickens, PhD, Kristin M Abaonza, Kurt A Brorson, PhD, Lakisha M Williams, Lakshmi Narasimhan, PhD, Lance Mde Souza, MBA, Laura Fontan, MS, Laura I Salazar, PhD, Laurel A Beer, Laurie Nelson, Laurie P Norwood, LCDR Jennifer H Rhyu, Lei Zhang, PhD, Leiyun Boone, PhD, Leslie Arivera Rosado, PhD, Li Lu, PhD, Libia M Lugo, Lillian Mcolon Mcknight, Linda F Murphy, Linda Thai, Lindsey Brown, PhD, Linh Tu, Lois K Gross, Lucila B Nwatu, Lydia S Chan, Lynda L Perry, PhD, Maan S Abduldayem, Mabel M Lee, Madushini Dharmasena, PhD, Maida Henesian (NMI), Maria Cecilia Tami, PhD, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marie A Fadden, Marie K Kinkade, Marion Michaelis, Mariza M Jafary, Mark Brunswick, PhD, Marsha W Major, Mary E Farbman, PhD, Mary E Storch, Massod Rahimi, PhD, Matthew B Casale, Maxwell Van Tassell, PhD, Megan T Ziegler, Mei Chiung Huang (Jo), Meredith P Soehl, Investigator, Merry Christie, PhD, Michael A Charles, Michael Shanks, MS, Michael T Cyrus, Michele Dougherty, PhD, Michelle Rfrazier Jessen, PhD, Michelle Yclark Stuart, Mihaly S Ligmond, Milos Dokmanovic, PhD, Min Shanmabel Liu, Monica Commerford, PhD, Monica Markovski, PhD, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra V Millarw, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nayan J Patel, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Nicholas Obiri, PhD, Omotunde O Osunsanmi, Pankaj H Amin, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patrick J Lynch, Paula A Trost, Peggy M Speight, Peter Adams, PhD, Peter E Baker, Peter Kessler, PhD, Phillip Angart, PhD, Prabhu P Raju, Prajakta A Varadkar, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, Ram Sihag, PhD, Ramon A Hernandez, Raquel Gonzalez Rivera, Rashmi Rawat, PhD, Raymond T Oji, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Reyes Candau Chacon, PhD, Richard Ledwidge (nmi), PhD, Richard W Berning, Richard W Thornton, Riley C Myers, PhD, Robert D Tollefsen, Robert Jennings, Robert Rodriguez, Roger F Zabinski, Ronald R Ruff, Rose Ashley, Ruth Moore, PhD, S Lori Brown, PhD MPH, Saleem A Akhtar, Salvatore N Randazzo, Sandra A Hughes, Sandra S Saniga, Sang Bong Lee, Sangeeta M Khurana, PhD, Santos E Camara, Sarah Arden, Sarah Kennett, PhD, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sena G Dissmeyer, Seneca D Toms, Serge L Beaucage, Sharon K Thoma, PharmD, Shawn E Larson, Sheilyn H Huang, Shelley H Beausoleil, Sherri J Jackson, Sidney B Priesmeyer, Stephanie A Slater, MS, Steven A Gonzales, Steven D Dittert, Steven Fong, MS, PhD, Steven Kozlowski, MD, Steven M Weinman, Steven P Donald, Stuart W Russell, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susanna E Ford, Suzanne N Vallez, Tamara L Ely, Tamara M Casselman, Thao T Kwan, Thea C Grome, Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy C Grome, Tracy Denison, PhD, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vaishali J Patel, Veronica Fuentes, MS, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Virginia L Meeks, Viviana Matta, Walden H Lee, Walter N Lange, Wayne E Seifert, Wendy G Tan, PhD, William Hallett, PhD, William V Millar, Xianghong Jing (Emily), PhD, Xiaokuang Lai, PhD, Xu Michael Di, PhD, Yanming An, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yi Wang, PhD, Ying Xin Fan, PhD, Yun Wu, PhD, Zachary L Stamm, Zerita White, Zhao Wang, PhD, Zhong Li, PhD, Ziyang Su, PhD

Dr. Ralph M Bernstein, PhD's Documents

Publish Date Document Type Title
September, 2004 EIR Grifols Diagnostic Solutions Inc. - EIR, 2004-09-24
February, 2004 FDA 483 Genentech, Inc. - Form 483, 2004-02-26
August, 2022 FDA 483 Biocon Biologics Limited - Form 483, 2022-08-26
September, 2011 FDA 483 Biogen MA Inc. - Form 483, 2011-09-30
September, 2018 FDA 483 KBI Biopharma, Inc. - Form 483, 2018-09-12
August, 2005 FDA 483 MSD International GmbH - Form 483, 2005-08-25
May, 2014 FDA 483 Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2014-05-30
February, 2022 FDA 483 Response Rentschler Biopharma SE - Form 483R, 2022-02-15
February, 2022 EIR Rentschler Biopharma SE - EIR, 2022-02-15
July, 2015 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2015-07-03
November, 2019 FDA 483 Daiichi Sankyo Chemical Pharma Co., Ltd.- Tatebayashi - Form 483, 2019-11-01
March, 2018 EIR Samsung Bioepis Co., Ltd. - EIR, 2018-03-07
September, 2012 FDA 483 IPSEN BIOPHARM LTD - Form 483, 2012-09-18
February, 2004 EIR Genentech, Inc. - EIR, 2004-02-26
June, 2022 FDA 483 CELLTRION Inc - Form 483, 2022-06-03
October, 2017 FDA 483 FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2017-10-31
July, 2018 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2018-07-17
January, 2015 FDA 483 UK Health Security Agency - Form 483, 2015-01-23
November, 2013 FDA 483 Biogen MA Inc. - Form 483, 2013-11-15
February, 2009 FDA 483 Bayer Healthcare Pharmaceuticals, Inc - Form 483, 2009-02-05
January, 2019 FDA 483 Amgen Singapore Manufacturing Pte. Ltd. - Form 483, 2019-01-29
March, 2018 FDA 483 Samsung Biologics Co., Ltd. - Form 483, 2018-03-14
February, 2009 EIR Bayer Healthcare Pharmaceuticals, Inc - EIR, 2009-02-05
March, 2019 FDA 483 Lonza AG - Form 483, 2019-03-29
September, 2015 EIR Scientific Protein Laboratories LLC - EIR, 2015-09-25
November, 2019 FDA 483 Daiichi Sankyo Chemical Pharma Co., Ltd. - Form 483, 2019-11-08
August, 2022 FDA 483 Biocon Biologics Limited - Form 483, 2022-08-26
August, 2022 FDA 483 Biocon Biologics Limited - Form 483, 2022-08-26
September, 2004 FDA 483 Grifols Diagnostic Solutions Inc. - Form 483, 2004-09-24
August, 2019 EIR AstraZeneca Pharmaceuticals LP - EIR, 2019-08-26
September, 2015 FDA 483 Scientific Protein Laboratories LLC - Form 483, 2015-09-25
February, 2022 FDA 483 Rentschler Biopharma SE - Form 483, 2022-02-15
February, 2009 FDA 483 Response Bayer Healthcare Pharmaceuticals, Inc - Form 483R, 2009-02-27
May, 2024 FDA 483 MSD Ireland (Carlow) - Form 483, 2024-05-28
February, 2024 FDA 483 CELLTRION Inc - Form 483, 2024-02-27
February, 2024 FDA 483 CELLTRION Inc - Form 483, 2024-02-27

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