FDA Investigator Dr. Zhou Chen (nmi), MD PhD

Dr. Zhou Chen (nmi), MD PhD has conducted inspections on 60 sites in 6 countries as of 06 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
60
Last Inspection Date:
06 May 2024
Investigator Role:
FDA Investigator
Redica ID:
100006410
Countries of Inspections:
United States of America, Korea (Republic of), India, China, Canada, Taiwan
FDA Investigators that have inspected at least one site in common with Dr. Zhou Chen (nmi), MD PhD:
Alan M Barker, Alberto A Viciedo, Alicia M Mozzachio, Allen Lou, Amanda E Lewin, PhD, Amber G Chung, Amber G Wardwell, Amy L Singer, Ana P Barido, Ana S Cabrera, Andrea A Branche, Andrew J Lang, Andrew M Barlow, Andrew R Wasko, Andrew W Harmon, Andria L Kuhlman, Angel K Sandhu, Anh M Lac, Ann Marie Montemurro, Anna M Brannen, Arianne L Motter, Arindam Dasgupta, PhD, Ashar P Parikh, Atul J Agrawal, Barbara A Rusin, Barbara J Holladay, Barbara J Rincon, Barbara Janine Breithaupt, Barbara L Rellahan, PhD, Betsy C Galliher, Betty Kay Baxter, Brandon L Mariner, Bruce H Mccullough, Byron Ho, DVM, Byungja E Marciante, Candace Y Gomez Broughton, Cara M Minelli, Carl A Anderson, Carl Lee, Carla C Tuite, Carla R Hinz, Carmen Y Fisher, Carol Rivera Lopez, PhD, Carolyn A Renshaw, CDR Rochelle B Young, RPh, MSA, Chaltu Nwakijra, Charles A Snipes, PhD, Charles R Bonapace, PhD, Charles R Cote, RIC, Chase Bourke, PhD, Chelsea W Lamm, Cheryl A Grandinetti, Ching Jeyg Chang, Christian D Lynch (CDL), Christine M Whitby, CSO, Christopher T Middendorf, Clinton D Priestley, Colleen E Burke, Connie P Rezendes, Corey K Reno, Courtney N Long, Craig T Rybus, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia Jim, CSO, Daniel J Grabicki, Daniel Pst Laurent, Daniel R Azar, Darin S Wiegers, David K Glasgow, David L Chon, David P Vanhouten, Dawn C Olenjack, Deborah A Greco, Deborah B Nixon, Debra Bower, Debra I Love, Debra Lboyd Seale, Dell S Moller, Denise L Burosh, Dina A Tallman, Donald B Mckechnie, Douglas A Campbell, Douglas C Kovacs, Douglas Fiorentino Lcdr, Douglas W Gronski, Dr. Abhijit Raha, PhD, Dr. Gopa Biswas, PhD, Dr. Hansong Chen, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dustin P Tran, Dylan D Yao, MD, PhD, Edward D Harris, Edward D Vains, Eias A Zahalka, Eileen A Liu, Emest F Bizjak, Emmanuel Adu Gyamfi, PhD, Eric J Cunningham, Eric Rothschild, Eric S Pittman, Erin D Mccaffery, Erin L Mcfiren, Erin M Mcdowell, Farhana Khan, Francis J Eng, Frederick M Lochner, Gabrielle J Swain, Gajendiran Mahadevan, PhD, Gary J Hagan, Geoffrey K Kilili, Gloria A Milster, Grace P Santos, Greg K Keshishyan, Gregory W Smith, Gwyn G Dickinson, Hanna L Potter, Heika R Bounds, Heika R Tait, Helen B Ricalde, Helen Verdel, Henry K Lau, Himanshu Gupta, PhD, Hugh M Mcclure, II, Humberto Z Gomez, Hung H Do, MS, Hyojong Kwon, PhD, Isaiah D Isakson, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jane M Kreis, Janet L Bowen, Janete F Guardia, Jasjeet K Sekhon, Jazmine N Still, Jean M Kelahan, Jeanne J Thai, Jeffrey M Watson, Jennifer C Adams, Jennifer L Jager, Jesse A Vazquez, Joanne M Schlossin, Jogy George, Johann M Fitch, John A Kadavil, PhD, Jolanna A Norton, Jonathan R Campos, Jose M Cayuela, Joseph A Piechocki, Joseph F Mcginnis, RPh, Joseph P Iser, MD, Joseph R Haynes, Joslyn K Brunelle, PhD, Joy Rkozlowski Klena, Julian C Hanson, Julie D Bringger, Jyoti B Patel, PhD, Kara A Scheibner, PhD, Karen E D'orazio, Karen M Kondas, Kathleen B Swat, Kathryn A Krentz, Ke Zhang, Kelli F Dobilas, Kellia N Hicks, Kenneth Nieves, Kent A Conforti, Kent C Faul, Kevin P Foley, Kula N Jha, Kurt A Brorson, PhD, Laine P Myers, Lakisha M Williams, Lance Mde Souza, MBA, Laura Fontan, MS, Lauren N Howard, LCDR Jennifer H Rhyu, Lequita M Mayhew, Li Hongpaul Yeh, PhD, Li Li, Liatte Kreuger, PharmD, Linda S Leja, Lori J Silverstein, Luann Mckinney, Lynette P Salisbury, Marcia A Worley, Marcus F Yambot, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Martin J Guardia, Martin K Yau, PhD, Mary E Storch, Mary Jeanet Mcgarry, Matthew C Watson, Melba Trivera Clavell, Melkamu Getie Kebtie, PhD, Michael F Skelly, PhD, Michael J Nerz, Michael Serrano, Michele Perry Williams, Mike M Rashti, Muralidhara B Gavini, PhD, Nancy A Bellamy, Nancy L Neiger, Nancy L Rolli, Natalie A Mickelsen, DVM, Nathan R Moon, Nebil A Oumer, Nicholas P Diorio, Nicholas Z Lu, Nicole S Williams, Niraj R Mehta, PhD, Norman K Starks, Nutan Mytle, Paul L Bellamy, Paula A Trost, Peter R Lenahan, Philip J Snoy, Phillip M Pontikos, Prabhu P Raju, Rachel C Harrington, Rafael Padilla, Raymond T Oji, Rebecca T Davis, Regina T Brown, Richard Heath Coats, Richard W Berning, Robert J Ham, Robert J Martin, Robert L Hummel, Ronald R Ruff, Rory K Geyer, Rosanna M Goodrich, Rose Ashley, Rose Ljean Mary, Ruth A Williams, Sandra A Hughes, Sandra Kershaw, Sandra S Saniga, Sarah Adella Fave, Scott B Laufenberg, Shalonda C Clifford, Sherri J Jackson, Sherry L Secrist, BLT DO, Shirley H Isbill, Sidney B Priesmeyer, Sinai I Davis, Sony Mathews, Sripal R Mada, PhD, Stacey A Priest, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephen J Kilker, Steven P Donald, Stuart W Russell, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan M Jackson, Susanne M Richardson, MS RAC, Teena H Aiken, Tenzin Jangchup, Thea C Grome, Theressa B Smith, Thomas J Arista, Thomas R Withers, Thomas W Nojek, Thunder N Dunkijacobs, Toyin B Oladimeji, Tracey Asinjen Wiersma, Uduak M Inokon, Uttaniti Limchumroon (Tom), Vickie J Kanion, Victor J Gangi, Victoria M Daddeo, Vlada Matusovsky, Wayne J Meyer, William D Tingley, William V Millar, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Ying Xin Fan, PhD, Yiyue Zhang (nmi), PhD, Young M Yoon, Yuanyuan Li, Yvette Mlacour Davis, Zhongren Wu

Dr. Zhou Chen (nmi), MD PhD's Documents

Publish Date Document Type Title
April, 2016 FDA 483 Labcorp Bedford LLC. - Form 483, 2016-04-29
June, 2018 FDA 483 Charles River Laboratories, Inc - Form 483, 2018-06-15
May, 2013 FDA 483 Hoffmann La Roche Inc - Form 483, 2013-05-09
August, 2010 EIR Merck & Company, Inc. - EIR, 2010-08-20
April, 2017 FDA 483 West China-Frontier Pharma Tech Co., Ltd. - Form 483, 2017-04-21
May, 2011 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2011-05-10
March, 2018 EIR Citoxlab North America Inc - EIR, 2018-03-02
July, 2015 FDA 483 Covance Pharmaceutical R&D (Shanghai) Co - Form 483, 2015-07-24
March, 2019 FDA 483 Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2019-03-08
April, 2016 EIR Labcorp Bedford LLC. - EIR, 2016-04-29
January, 2015 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2015-01-21
October, 2009 FDA 483 Charles River Laboratories, Inc - Form 483, 2009-10-23
September, 2014 FDA 483 AbbVie Inc. - Form 483, 2014-09-12
August, 2019 FDA 483 BioReliance Corporation - Form 483, 2019-08-08
February, 2012 FDA 483 SRI International - Form 483, 2012-02-17
July, 2015 FDA 483 Response Covance Pharmaceutical R&D (Shanghai) Co - Form 483R, 2015-08-06
September, 2011 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2011-09-27
November, 2009 EIR Altasciences Preclinical Seattle, LLC - EIR, 2009-11-20
March, 2019 FDA 483 JOINN Laboratories (Suzhou) - Form 483, 2019-03-15
April, 2017 FDA 483 National Beijing Center For Drug Safety Evaluation And Resea - Form 483, 2017-04-28
July, 2017 FDA 483 Labcorp Bedford LLC. - Form 483, 2017-07-21
May, 2013 EIR Hoffmann La Roche Inc - EIR, 2013-05-09
August, 2019 FDA 483 Response BioReliance Corporation - Form 483R, 2019-08-08
June, 2009 EIR Merck & Company, Inc. - EIR, 2009-06-05
August, 2009 FDA 483 Frontage Laboratories, Inc. - Form 483, 2009-08-14
December, 2011 FDA 483 Battelle Memorial Institute - Form 483, 2011-12-22
October, 2014 FDA 483 Charles River Laboratories - Form 483, 2014-10-10
June, 2018 EIR Q2 Solutions - EIR, 2018-06-29
August, 2016 FDA 483 JOINN Laboratories (Suzhou) - Form 483, 2016-08-12
February, 2020 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2020-02-03
February, 2011 EIR BioReliance Corporation - EIR, 2011-02-04
September, 2019 EIR Lovelace Biomedical Research Institute - EIR, 2019-09-13
November, 2018 EIR BioMarin Pharmaceutical Inc. - EIR, 2018-11-09
October, 2012 EIR Battelle Memorial Institute - EIR, 2012-10-17
October, 2016 FDA 483 Amphastar Laboratories Inc - Form 483, 2016-10-21
July, 2010 EIR Charles River Laboratories Cleveland, Inc. - EIR, 2010-07-16
October, 2012 FDA 483 Response Battelle Memorial Institute - Form 483R, 2012-10-24
March, 2010 EIR Charles River Laboratories, Inc. - EIR, 2010-05-18
August, 2017 FDA 483 Oeyama-Moto-Medical Group Foundation, LLC - Form 483, 2017-08-11
November, 2019 EIR Battelle Memorial Institute - EIR, 2019-11-08
June, 2014 FDA 483 Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2014-06-13
April, 2009 FDA 483 BASi Gaithersburg, LLC - Form 483, 2009-04-22
September, 2012 FDA 483 Korea Institute of Toxicology - Form 483, 2012-09-26
September, 2013 FDA 483 Joinn Laboratories Co. Ltd. - Form 483, 2013-09-20
July, 2013 FDA 483 Charles River Laboratories, Inc. - Form 483, 2013-07-12
June, 2018 EIR Charles River Laboratories, Inc - EIR, 2018-06-15
November, 2009 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2009-11-20
July, 2013 EIR Charles River Laboratories, Inc. - EIR, 2013-07-12
August, 2009 EIR Frontage Laboratories, Inc. - EIR, 2009-08-14
August, 2018 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2018-08-17
February, 2012 FDA 483 Response SRI International - Form 483R, 2012-03-05
September, 2014 EIR AbbVie Inc. - EIR, 2014-09-12
October, 2012 FDA 483 Battelle Memorial Institute - Form 483, 2012-10-17
May, 2015 FDA 483 Colorado Histo-Prep - Form 483, 2015-05-19
September, 2013 FDA 483 Pharmaron - Form 483, 2013-09-13
September, 2017 EIR Shanghai Medicilon Inc. - EIR, 2017-09-15
August, 2009 FDA 483 Response Frontage Laboratories, Inc. - Form 483R, 2009-09-04
November, 2013 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2013-11-22
October, 2016 EIR Amphastar Laboratories Inc - EIR, 2016-10-21
February, 2011 FDA 483 BioReliance Corporation - Form 483, 2011-02-04
July, 2010 FDA 483 Charles River Laboratories Cleveland, Inc. - Form 483, 2010-07-16
September, 2019 FDA 483 Lovelace Biomedical Research Institute - Form 483, 2019-09-13
January, 2015 EIR U.S. Army Medical Research Institute of Infectious Diseases - EIR, 2015-01-21
August, 2019 EIR BioReliance Corporation - EIR, 2019-08-08
December, 2019 FDA 483 Vimta Labs Limited - Form 483, 2019-12-18
May, 2019 FDA 483 Pharmaron - Form 483, 2019-05-24
October, 2014 EIR Charles River Laboratories - EIR, 2014-10-10
May, 2024 FDA 483 Suzhou Xishan Zhongke Drug R&D, Co. Ltd. - Form 483, 2024-05-21
May, 2024 FDA 483 Joinn Laboratories Co. Ltd. - Form 483, 2024-05-21
March, 2024 FDA 483 Level Biotechnology Inc. - Form 483, 2024-03-22

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