FDA Investigator Xikui Chen (nmi), PhD

Xikui Chen (nmi), PhD has conducted inspections on 50 sites in 10 countries as of 24 Jul 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
50
Last Inspection Date:
24 Jul 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Netherlands, Germany, India, Czechia, Canada, United Kingdom of Great Britain and Northern Ireland, China, France, Taiwan
FDA Investigators that have inspected at least one site in common with Xikui Chen (nmi), PhD:
Ademola O Daramola, Aimee J Edwin, Alan P Kurtzberg, Alanna L Mussawwir Bias, Albert F Peacock, PhD, Alice S Tsao, Alicia M Mozzachio, Allen F Hall, Allen Lou, Amanda E Lewin, PhD, Amatul H Marium, Amy Franklin, Amy Lynn Frankshun, PhD, Andrea A Branche, Andrea D Swingle, Angel S Johnson, Angela E Glenn, Anthony E Keller, RPh, Arduino Frankovic, Arindam Dasgupta, PhD, Aurora Miha Trifanov, Azza Talaat, Barbara A Rusin, Barbara D Wright, Barbara J Holladay, Barbara J Maulfair, Barbara Janine Breithaupt, Bijoy Panicker, Brandon L Mariner, Brenda W Uratani, PhD, Brooke K Higgins, Byron Ho, DVM, Byungja E Marciante, Camerson E Moore, Candice C Mandera, Candice J Cortes, Carl J Montgomery, Carla J Lundi, Carol Rivera Lopez, PhD, CDR Kimberly Y Martin, CDR Rochelle B Young, RPh, MSA, Charanjeet Jassal, Charisse K Green, Charles A Snipes, PhD, Charles D Brown, Chelsea W Lamm, Chris A Sack, Christopher R Czajka, Christopher T Middendorf, Corey K Reno, Courtney N Long, Craig A Garmendia, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia L Evitt, Daniel J Grabicki, Daniel L Aisen, Darren D Holaday, David L Chon, Dawn C Olenjack, Dawn L Wydner, Deborah B Nixon, Denise L Burosh, Denise M Visco, Investigator, Denise M Visu, Diane L Raccasi, Dianne H Milazzo, Dina A Tallman, Douglas C Kovacs, Douglas W Gronski, Dr. Abhijit Raha, PhD, Dr. Gopa Biswas, PhD, Dr. Hansong Chen, PhD, Dr. Mark J Seaton, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Dylan D Yao, MD, PhD, Edward D Mcdonald, Eileen A Liu, Elise A Murphy, Emest F Bizjak, Emily J Orban, Eric C Nielsen, Eric M Mueller, PharmD, Eric S Pittman, Erika V Butler, Erin D Mccaffery, Erin L Mcfiren, Farhana Khan, Gajendiran Mahadevan, PhD, Gam S Zamil, Gene D Arcy, George Ivan Wey, Gifford Whitehurst, Jr, Gloria J Baca, MS, Gregory S Larson, Gulshan R Anand, Gwyn G Dickinson, Hasan A Irier, PhD, Hector Jcolon Torres, Helen B Ricalde, Himanshu Gupta, PhD, Hugh M Mcclure, II, Huixia Zhang, Iram R Hassan, PhD, Israel Santiago, OCM, Jacqueline A O'shaughnessy, PhD, Jagan Mohanr Parepally, PhD, James A Jagon, James C Maclaughlin, James M Kewley, James M Mason, Jane E Nelson, Jane M Kreis, Janete F Guardia, Jason K Morgan, Jeffrey A Sommers, Jennifer A Longie Vollom, Jennifer C Adams, Jessica E Hensley, Jessica L Peterson, Joanne M Schlossin, Jodi M Gatica, Joel D Martinez, Jogy George, John A Iwen, John A Kadavil, PhD, Jonathan R Campos, José E Meléndez, Joseph R Haynes, Joseph R Lambert, Joy P Matthias, Joy Rkozlowski Klena, Jyoti B Patel, PhD, Kara A Scheibner, PhD, Karen M Cooper, Karishma G Gopaul, Katherine Szestypalow, Keith M Reilly, Kenneth R Merritt, Kent C Faul, Kevin A Gonzalez, Kevin P Foley, Kham Phommachanh, Kristy A Zielny, Larry K Austin, Lata C Mathew, PhD, Latonya M Mitchell, Laura E Garcia, Laverne Puckett, Lawrence W Farina, LCDR Angelica M Chica, LCDR Ismael Olvera, IV, LCDR Jennifer H Rhyu, LCDR Matthew R Mcnew, MPH, REHS/RS, Li Hongpaul Yeh, PhD, Linda R Kuchenthal, Linda S Leja, Linda Thai, Lisa B Orr, Loretta Nemchik, Lori A Gioia, LTJG Matthew R Palo, Luis A Dasta, M A Abel I, Makini Cobourne Duval, PhD, Margaret M Annes, Mark R Mcclain, Martin K Yau, PhD, Matthew A Spataro, Matthew B Casale, Matthew C Watson, Meisha Waters, Melkamu Getie Kebtie, PhD, Michael A Charles, Michael A Taylor, Michael F Skelly, PhD, Michael G Sinkevich, Michael L Chasey, Michael R Klapal, Michael Serrano, Mike M Rashti, Mindy M Chou, Minh D Phan, Mohsen Rajabi Abhari, FDA, Mra Davism, Mra Narulaa, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy A Bellamy, Nancy L Rolli, Nancy M Espinal, Natalie A Mickelsen, DVM, Nathaniel R Esaw, Neal D Singletary, PhD, Neil J Bonzagni, PhD MPH, Nicholas A Violand, Nicholas F Lyons, Nicholas L Paulin, Nicola M Fenty Stewart, Nicole E Knowlton, Nilufer M Tampal, PhD, Niraj R Mehta, PhD, Nutan Mytle, Pamela L Velez Vega, Pankaj H Amin, Parul M Patel, Patrick C Klotzbuecher, Patrick D Stone, MS, Patrick L Wisor, Paul A Bonneau, Paul L Bellamy, Paul Mouris, Peter R Lenahan, Rajiv R Srivastava, Richard W Berning, Robert Barron, Robert C Steyert, Robert M Barbosa, Rodney D Combs, Ruben C Ayala, PharmD, Russell K Riley, S Lori Brown, PhD MPH, Sam H Haidar, PhD, Samina S Khan, Samuel H Chan, PharmD, Sandra S Saniga, Sayyem H Akbar, Scott B Laufenberg, Sean Y Kassim, PhD, Seongeun Cho (Julia), PhD, Sharon K Thoma, PharmD, Sharon L Matson, Sharon M Harold, Sherry G Bous, Sherry L Secrist, BLT DO, Shirley S Wen, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey A Priest, Stanley Au, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Steven M Weinman, Susan D Yuscius, Susanna E Ford, Susanne M Richardson, MS RAC, Tamal K Chakraborti, PhD, Tara C Singh, Tara G Bizjak, Tara K Carmody, Thomas P Hansen, Thomas W Gordon, Tiffani D Wilson, Torrance J Slayton, Tracey Asinjen Wiersma, Tracey L Harris, Traci C Kelm, Truong Xuan Nguyen (Andy), Unnee Ranjan, Vickie J Kanion, Vioela J Caze, Vivin George, Walden H Lee, William D Tingley, William H Linkroum, Xingfang Li, MD, Yih Chain Huang, PhD, Yiying E Chen, Yiyue Zhang (nmi), PhD, Young M Choi, PhD, Yumi J Hiramine

Xikui Chen (nmi), PhD's Documents

Publish Date Document Type Title
March, 2013 EIR Inotiv, Inc. - EIR, 2013-03-08
April, 2010 FDA 483 COVANCE BIOANALYTICAL SERVICES, LLC - Form 483, 2010-04-16
June, 2013 FDA 483 Xenobiotic Laboratories, Inc. - Form 483, 2013-06-21
May, 2011 FDA 483 U.S. Army Medical Research Institute of Infectious Diseases - Form 483, 2011-05-10
December, 2010 FDA 483 Cetero Research - Form 483, 2010-12-10
August, 2013 FDA 483 WuXi AppTec Co., Ltd. - Form 483, 2013-08-16
March, 2013 FDA 483 Response Inotiv, Inc. - Form 483R, 2013-03-27
March, 2010 FDA 483 Forest Research Institute Inc - Form 483, 2010-03-12
October, 2009 FDA 483 PPD Development, L.P. - Form 483, 2009-10-30
August, 2009 FDA 483 Schering Corporation - Form 483, 2009-08-07
April, 2023 FDA 483 ScieGen Pharmaceuticals INC - Form 483, 2023-04-21
August, 2009 EIR Medtox Laboratories, Inc. - EIR, 2009-08-21
August, 2012 FDA 483 PRACS Institute, Ltd. - Form 483, 2012-08-06
August, 2013 EIR Frontage Laboratories (Shanghai) Co., Ltd. - EIR, 2013-08-09
November, 2014 EIR Peter Pruim - EIR, 2014-11-07
June, 2013 EIR Xenobiotic Laboratories, Inc. - EIR, 2013-06-21
August, 2013 FDA 483 Frontage Laboratories (Shanghai) Co., Ltd. - Form 483, 2013-08-09
August, 2012 EIR PRACS Institute, Ltd. - EIR, 2012-08-06
July, 2012 FDA 483 TDM Pharmaceutical Research, LLC - Form 483, 2012-07-20
May, 2014 EIR Charles River Laboratories - EIR, 2014-05-02
October, 2009 EIR PPD Development, L.P. - EIR, 2009-10-30
July, 2010 FDA 483 Celerion, Inc - Form 483, 2010-07-02
April, 2008 FDA 483 COVANCE BIOANALYTICAL SERVICES, LLC - Form 483, 2008-04-25

Experience Redica Systems’ 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.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

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