FDA Investigator Dr. Ralph M Bernstein, PhD

Dr. Ralph M Bernstein, PhD has inspections in 12 countries as of 11 Oct 2023. Dr. Ralph M Bernstein, PhD has collaborated with a combinined 6066 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
27
Last Inspection Date:
11 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100007283
Country:
United States of America, India, Germany, Japan, Korea (Republic of), Austria, United Kingdom of Great Britain and Northern Ireland, Singapore, Ireland, Switzerland, Denmark
Co-Investigator(s):
Abdur Razzaque, Adam R Cooke, 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 Core, 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, 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, Hai Lien T Phung, Haoheng Yan, PhD, Helen B Ricalde, Henry K Lau, Henry X Lau, Herbert M Corbello, Howard Anderson, PhD, Hyung Yul Lee, Ibad U Khan, Ivis L Negrón, Ivis Lnegron Torres, 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, John D White, 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 M De 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 N Thai, 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), Mei Chiung J Huang, Meredith P Soehl, Investigator, Merry Christie, PhD, Michael A Charles, Michael Shanks, MS, Michele Dougherty, PhD, Michelle Rfrazier Jessen, PhD, Michelle Y Clark Stuart, Mihaly S Ligmond, Milos Dokmanovic, PhD, Min Shanma Liu, Monica Commerford, PhD, Monica Markovski, PhD, Mra Davism, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nayan J Patel, Nayan Patel, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Nicholas Obiri, PhD, Omotunde O Osunsanmi, Patricia Fhughes Troost, 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, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, Ram Sihag, PhD, Ramon A Hernandez, Raquel Gonzalez, 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 Rodriguez, Robert W Jennings, Roger F Zabinski, Ronald R Ruff, Rose M Ashley, Ruth Moore, PhD, S Lori Brown, PhD MPH, 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 Beaucage, Sharon K Thoma, PharmD, Shawn E Larson, Shelley H Beausoleil, Sherri J Jackson, Sidney B Priesmeyer, State Agency, 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, Susanna E Ford, Analyst, Susant Hadman, 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, 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, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Ziyang Su, PhD

Dr. Ralph M Bernstein, PhD's Documents

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

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