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

Dr. Zhou Chen (nmi), MD PhD has inspections in 6 countries as of 14 Sep 2023. Dr. Zhou Chen (nmi), MD PhD has collaborated with a combinined 5516 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:

Last Inspection Date:

14 Sep 2023

Investigator Role:

FDA Investigator

Redica ID:

100006410

Country:

United States of America, Canada, China, India, Taiwan

Co-Investigator(s):

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, Arindam Dasgupta, PhD, Ashar P Parikh, Audria L Kuhlman, Barbar J Breithaupt, Barbara A Rusin, Barbara J Holladay, Barbara J Rincon, Barbara Janine Breithaupt, Barbara L Rellahan, PhD, Betsy C Galliher, Betty K 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 Mrivera Lopez, PhD, Carolyn A Renshaw, CDR Rochelle B Young, RPh, MSA, Chaltu N Wakijra, Charles A Snipes, PhD, Charles R Bonapace, PhD, Charles R Cote, RIC, Chase Bourke, PhD, Chery Grandinetti, Ching Jeyg Chang, Christian D Lynch (CDL), Christine M Smith, Christine Mwhitby Smith, Christopher T Middendorf, Clinton D Priestley, Connie P Rezendes, Corey K Reno, Corey Reno, Courtney N Long, Craig T Rybus, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia Jim, CSO, Da Lin Yao, MD, PhD, 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 B Nixon, Debra Bower, Debra I Love, Debra L Boyd Seale, Dell S Moller, Denise L Burosh, Dina A Tallman, Donald B Mckechnie, Douglas A Campbell, Douglas C Kovacs, Douglas Fiorentino Lcdr, Douglas Florentino, 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 Haris, Edward D Harris, Edward D Vains, Eias A Zahalka, Eileen A Liu, Emest F Bizjak, Emmanuel Adu Gyamfi, Eric J Cunningham, Eric Rothschild, Eric S Pittman, Erin D Mccaffery, Erin L Mcfiren, Erin M Mcdowell, Erin Mcdowell, Farhana Khan, Francis J Eng, Franois J Eng, Frederick M Lochner, Gajendiran Mahadevan, PhD, Gary J Hagan, Gary S 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, High M Mcclure, III, 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, Kelli N Hicks, 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 M De 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 T Rivera, 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 Mehta, Niraj R Mehir, 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 Ljean Mary, Rose M Ashley, Ruth A Williams, Sandra A Hughes, Sandra Kershaw, Sandra S Saniga, Sarah Adella Fave, Scott B Laufenberg, Scott B Lausanberg, Scott B Loufoubery, Shalonda C Clifford, Sherri J Jackson, Sherry L Secrist, BLT DO, Shirley H Isbill, Sidney B Priesmeyer, Sinai Davis, Sony Mathews, Sripal R Mada, PhD, Stacey A Priest, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephen J Kilker, Stephen K Kilker, Steven P Donald, Stuart W Russell, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan M Jackson, Susan Yuscius, Susanne M Richardson, MSc RAC ELS, Susanne Mrichardsonmsc 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
August, 2019	FDA 483 Response	Bioreliance Corporation - Form 483R, 2019-08-08
August, 2009	FDA 483	Frontage Laboratories, Inc. - Form 483, 2009-08-14
July, 2013	FDA 483	Charles River Laboratories, Inc. - Form 483, 2013-07-12
August, 2009	EIR	Frontage Laboratories, Inc. - EIR, 2009-08-14
September, 2017	EIR	Shanghai Medicilon Inc. - EIR, 2017-09-15
September, 2019	FDA 483	Lovelace Biomedical Research Institute - Form 483, 2019-09-13
August, 2019	EIR	Bioreliance Corporation - EIR, 2019-08-08
September, 2012	FDA 483	Korea Institute of Toxicology - Form 483, 2012-09-26
January, 2015	EIR	U.S. Army Medical Research Institute of Infectious Diseases - EIR, 2015-01-21
October, 2016	EIR	Amphastar Laboratories Inc - EIR, 2016-10-21
June, 2009	EIR	Merck & Company, Inc. - EIR, 2009-06-05
June, 2018	EIR	Q2 Solutions - EIR, 2018-06-29
July, 2017	FDA 483	Labcorp Bedford LLC. - Form 483, 2017-07-21
September, 2013	FDA 483	Joinn Laboratories Co. Ltd. - Form 483, 2013-09-20
April, 2017	FDA 483	National Beijing Center For Drug Safety Evaluation And Resea - Form 483, 2017-04-28
April, 2016	EIR	Labcorp Bedford LLC. - EIR, 2016-04-29
April, 2017	FDA 483	West China-Frontier Pharma Tech Co., Ltd. - Form 483, 2017-04-21
August, 2010	EIR	Merck & Company, Inc. - EIR, 2010-08-20
January, 2015	FDA 483	U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2015-01-21
May, 2013	EIR	Hoffmann La Roche Inc - EIR, 2013-05-09
June, 2018	FDA 483	Charles River Laboratories, Inc - Form 483, 2018-06-15
February, 2011	EIR	Bioreliance Corporation - EIR, 2011-02-04
September, 2011	FDA 483	Altasciences Preclinical Seattle, LLC - Form 483, 2011-09-27
October, 2014	FDA 483	Charles River Laboratories - Form 483, 2014-10-10
December, 2011	FDA 483	Battelle Memorial Institute - Form 483, 2011-12-22
August, 2016	FDA 483	JOINN Laboratories (Suzhou) - Form 483, 2016-08-12
August, 2019	FDA 483	Bioreliance Corporation - Form 483, 2019-08-08
February, 2012	FDA 483	SRI International - Form 483, 2012-02-17
November, 2009	EIR	Altasciences Preclinical Seattle, LLC - EIR, 2009-11-20
November, 2013	FDA 483	Altasciences Preclinical Seattle, LLC - Form 483, 2013-11-22
October, 2016	FDA 483	Amphastar Laboratories Inc - Form 483, 2016-10-21
March, 2010	EIR	Charles River Laboratories, Inc. - EIR, 2010-03-03
April, 2016	FDA 483	Labcorp Bedford LLC. - Form 483, 2016-04-29
February, 2011	FDA 483	Bioreliance Corporation - Form 483, 2011-02-04
October, 2012	EIR	Battelle Memorial Institute - EIR, 2012-10-17
July, 2015	FDA 483 Response	Covance Pharmaceutical R&D (Shanghai) Co - Form 483R, 2015-08-06
November, 2018	EIR	BioMarin Pharmaceutical Inc. - EIR, 2018-11-09
June, 2014	FDA 483	Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2014-06-13
September, 2013	FDA 483	Pharmaron - Form 483, 2013-09-13
October, 2009	FDA 483	Charles River Laboratories, Inc - Form 483, 2009-10-23
November, 2009	FDA 483	Altasciences Preclinical Seattle, LLC - Form 483, 2009-11-20
September, 2014	FDA 483	AbbVie Inc. - Form 483, 2014-09-12
November, 2019	EIR	Battelle Memorial Institute - EIR, 2019-11-08
July, 2010	EIR	Charles River Laboratories Cleveland, Inc. - EIR, 2010-07-16
February, 2020	FDA 483	U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2020-02-03
June, 2018	EIR	Charles River Laboratories, Inc - EIR, 2018-06-15
July, 2010	FDA 483	Charles River Laboratories Cleveland, Inc. - Form 483, 2010-07-16
October, 2012	FDA 483 Response	Battelle Memorial Institute - Form 483R, 2012-10-24
December, 2019	FDA 483	Vimta Labs Limited - Form 483, 2019-12-18
July, 2015	FDA 483	Covance Pharmaceutical R&D (Shanghai) Co - Form 483, 2015-07-24
October, 2014	EIR	Charles River Laboratories - EIR, 2014-10-10
May, 2015	FDA 483	Colorado Histo-Prep - Form 483, 2015-05-19
May, 2013	FDA 483	Hoffmann La Roche Inc - Form 483, 2013-05-09
March, 2018	EIR	Citoxlab North America Inc - EIR, 2018-03-02
September, 2014	EIR	AbbVie Inc. - EIR, 2014-09-12
September, 2019	EIR	Lovelace Biomedical Research Institute - EIR, 2019-09-13
February, 2012	FDA 483 Response	SRI International - Form 483R, 2012-03-05
March, 2019	FDA 483	JOINN Laboratories (Suzhou) - Form 483, 2019-03-15
May, 2011	FDA 483	U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2011-05-10
May, 2019	FDA 483	Pharmaron - Form 483, 2019-05-24
August, 2017	FDA 483	Oeyama-Moto-Medical Group Foundation, LLC - Form 483, 2017-08-11
March, 2019	FDA 483	Wuxi Apptec Suzhou Co.,Ltd - Form 483, 2019-03-08
July, 2013	EIR	Charles River Laboratories, Inc. - EIR, 2013-07-12
August, 2009	FDA 483 Response	Frontage Laboratories, Inc. - Form 483R, 2009-09-04
April, 2009	FDA 483	BASI Gaithersburg, LLC - Form 483, 2009-04-22
October, 2012	FDA 483	Battelle Memorial Institute - Form 483, 2012-10-17
August, 2018	FDA 483	Labcorp Early Development Laboratories, Inc. - Form 483, 2018-08-17

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

Total inspections conducted
483 rate
OAI rate
Warning Letter rate
Inspections by Industry, Scope, and Inspection Reason
And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

Talk to sales to access our investigator profiles

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

Pre-Approval Inspection (PAI) trends
The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
Latest 483s: see what the trends are across all FDA Investigators
CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

Full inspection histories for your vendors down to the specific site level
All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more