FDA Investigator Mark E Chan

Mark E Chan has conducted inspections on 206 sites in 15 countries as of 13 May 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
206
Last Inspection Date:
13 May 2019
Investigator Role:
FDA Investigator
Redica ID:
100006193
Countries of Inspections:
Japan, China, Singapore, Switzerland, United States of America, Denmark, Sweden, Ireland, Korea (Republic of), Malaysia, Netherlands, Taiwan, Belgium, Germany, United Kingdom of Great Britain and Northern Ireland
FDA Investigators that have inspected at least one site in common with Mark E Chan:
Adam S Freeman, Akbar J Zaidi, Alexandria L Capuano, Alla Dubrovsky, Althea A Williams, Amanda S Zorn, Amogh Pathi, Amy M Cramer, Andrea P Scott, Angel K Sandhu, Angelica G Aziz, Arduino Frankovic, Arthur S Williams, Jr, Ashar P Parikh, Ashleigh P Wodushek, Ashley A Mutawakkil, Barbara A Crowl, Barbara J Moynier, Beverly A Gallauresi, Brittany D Mccracken, Bryan A Galvez, Bryan J Love, Carl Lee, Carol A Llewellyn, Caryn M Mcnab, Catherine J Laufmann, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, Christine I Shaw, Christine M Parmentier, Christopher B May, Christopher W Buser, Cindy W Lewis, Creighton T Tuzon, Cristina E Ortega, Cristina O Dar, Cynthia L Gorveatt, Daniel C Geffin, Daniel J Lahar, Daniel J Roberts, Darren S Brown, David G Eng, David H Smith, David M Wilkinson, David P Vanhouten, Deborah A Nebenzahl, Denise D Dion, Diane Cvan Leeuwen, Dianiris C Ayala, Dolores Harper, Donna Ltartaglino Besone, Dr. Xingxiang Li, Edna J Hidalgo, Elizabeth A Dakan, Ellen J Tave, Emil P Wang, JD, Emma R Schaefer, Eric J Heinze, Eric M Padgett, Eric W Anderson, Felix J Marrero, Francis J Eng, Frank J Marciniak, Gary L Zaharek, Gene D Arcy, George R Richards, Gerald N Mcgirl, DDS, Gulshan R Anand, Harjap K Atwal, Humberto Z Gomez, Huy T Pham, Jacqueline M Cleary, Jacqueline S Warner, James A Beaulieu, James A Lane, James C Lee, PharmD, James D Hildreth, James M Odonnell, Jeffrey M Watson, Jeffrey P Raimondi, Jeffrey S Buckser, Jeffrey W Shrifter, DPM, Jesse A Vazquez, Joan T Briones, Joanne Hosting, Jocelyn T Ramos, John A Gonzalez, John A Liu, John A Sciacchitano, John F Murray, Jr, Jolanna A Norton, Jolene S Hedgecock, Jonathan R Campos, Joseph A Seitz, III, Juan A Morales, Jude C Dikes, Kaarin M Slotte, Karen A Coleman, Karen D Phung, Karl D Hezel, Katarzyna Plona, Katlin N Stubbs, Kavita K Lalwani, Kenya Destin, Keren Arkin, Kevin P Foley, Kimberly L Anderson, Kimberly L Pruszko, Kimberly Lewandowski Walker, Kinh Q Mac, Kirtida Patel, Kristin M Abaonza, Kwong P Lee, L Gnnmassimia Massimilla, PharmD, Lance A Finnical, Lance Mde Souza, MBA, Larkin R Buckalew, Lauren E Skokan, Laverne Puckett, Lawton W Lum, LCDR Jennifer H Rhyu, Leo J Lagrotte, Leonard H Lavi, Linda Linh N Adams, Linda S Shook, Linda Thai, Lori A Carr, Lori J Silverstein, Lorraine N Dixon, Lorraine N Williams, LT Mark A Chen, MPH, Lucila B Nwatu, Lydia S Chan, Lynda L Perry, PhD, Macropolk, Maida Henesian (NMI), Marie K Kinkade, Mary R Hole, Maryam Tabatabaie, Matthew A Walburger, Matthew D Schnittker, Matthew M Vernon, Melanie W Pishnery, Michelle J Glembin, Michelle L Tripp, Minerva Rogers, Norman Wong, Patricia A Mcilroy, Paul M Kawamoto, Perry H Gambrell, Peter E Baker, Phillip M Pontikos, Quynh H Strandberg, Randall F Albright, Randall J Plunkett, Ravi S Harapanhalli, Raymond T Oji, Rebecca T Davis, Reginald Walker, Richard L Bartlett, Richard L Rutherford, Robert D Tollefsen, Roberta K Smith, Roger D Gawne, Ronald P Boyce, Roy Baby, Sandra S Saniga, Sarah A Hassas, Scott K Zika, Seema S Singh, Sergio Chavez (NMI), Sherri J Jackson, Stanley B Eugene, BS, BME, Stephen C Smith, Stephen D Eich, Steve P Yost, Steven R Ziser, Suzanne M Healy, Tamara S Rosbury, Terri E Gibson, Thai T Duong, Thea C Grome, Timothy C Grome, Uduak M Inokon, Vibhakar J Shah, PhD, Vickie L Anderson, Victor Spanioli, Vivian Garcia, Walden H Lee, William D Tingley, William V Millar, Xiaojun Yan, Yong Hu

Mark E Chan's Documents

Publish Date Document Type Title
July, 2013 FDA 483 Haas Software - Form 483, 2013-07-10
September, 2008 EIR DePuy (Ireland) - EIR, 2008-09-11
August, 2009 FDA 483 Penumbra Inc. - Form 483, 2009-08-28
August, 2003 EIR Eldon Biologicals A/S - EIR, 2003-08-27
November, 2015 FDA 483 Pulsar Vascular Inc. - Form 483, 2015-11-13
January, 2000 EIR Medtronic Vascular, Inc. - EIR, 2000-01-12
June, 2003 EIR Calypte Biomedical Corp - EIR, 2003-06-05
March, 2012 FDA 483 Chalgren Enterprises, Inc. - Form 483, 2012-03-28
May, 2015 FDA 483 Laax, Inc. - Form 483, 2015-05-22
December, 2017 FDA 483 Laser Dental Innovations - Form 483, 2017-12-14
October, 2011 FDA 483 Intraop Medical Corporation - Form 483, 2011-10-06
June, 2004 FDA 483 ALZA Corporation - Form 483, 2004-05-14
May, 2019 FDA 483 Shenzhen Jiacom Technology Co., Ltd - Form 483, 2019-05-09
May, 2019 FDA 483 Zhejiang Runqiang Medical Instruments Co., Ltd. - Form 483, 2019-05-16
November, 2002 FDA 483 Abbott Vascular, Inc. - Form 483, 2002-11-26
September, 2015 FDA 483 I-see Vision Technology Inc - Form 483, 2015-09-10
June, 2011 FDA 483 OroScience Inc. - Form 483, 2011-06-23
January, 2007 FDA 483 Intuitive Surgical, Inc. - Form 483, 2007-01-09
August, 2003 FDA 483 Response Eldon Biologicals A/S - Form 483R, 2004-04-14
August, 2013 FDA 483 MAST Biosurgery USA Inc - Form 483, 2013-08-08
May, 2012 FDA 483 Covidien, LLC - Form 483, 2012-05-17
February, 2016 EIR AccessClosure, Inc., A Cardinal Health Company - EIR, 2016-02-01
April, 2019 FDA 483 Laser Dental Innovations - Form 483, 2019-04-18
May, 2015 FDA 483 Helio USA Inc - Form 483, 2015-05-12
May, 2000 EIR Oxford Instruments Medical, LtD. - EIR, 2000-05-19
April, 2013 FDA 483 Hotspur Technologies - Form 483, 2013-04-05
July, 2003 EIR W. L. Gore & Associates, Inc. - EIR, 2003-07-24
July, 2003 EIR Bayer Healthcare, LLC - EIR, 2003-07-07
June, 2002 FDA 483 Lifescan Inc - Form 483, 2002-06-10
September, 2003 EIR International Brachytherapy, s.a. (IBt) - EIR, 2003-09-04
April, 2015 EIR Olympus Corporation of the Americas - EIR, 2015-04-02
August, 2015 EIR Stellartech Research Corporation - EIR, 2015-08-20
November, 2002 EIR Abbott Vascular, Inc. - EIR, 2002-11-26
September, 2012 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2012-09-27
August, 2003 FDA 483 Eldon Biologicals A/S - Form 483, 2003-08-27
March, 2011 FDA 483 Stryker Corporation - Form 483, 2011-03-22
October, 2003 FDA 483 Boston Scientific Corporation - Form 483, 2003-10-07
July, 2003 FDA 483 Response Bayer Healthcare, LLC - Form 483R, 2003-07-28
September, 2003 FDA 483 International Brachytherapy, s.a. (IBt) - Form 483, 2003-09-04
June, 2004 FDA 483 ALZA Corporation - Form 483, 2004-06-16
September, 2002 EIR Latexx Manufacturing Sdn Bhd - EIR, 2002-09-19
December, 2018 FDA 483 Duke Empirical Inc. - Form 483, 2018-12-21
February, 2012 FDA 483 Angiodynamics Inc - Form 483, 2012-02-13
May, 2000 EIR Lewicki Microelectronic Gmbh - EIR, 2000-05-25
June, 2005 EIR Lifescan Inc - EIR, 2005-06-30
August, 2001 FDA 483 HDC Corporation - Form 483, 2001-08-21
November, 2012 FDA 483 Alexza Pharmaceuticals, Inc. - Form 483, 2012-11-08
October, 2009 FDA 483 Applied Ozone Systems - Form 483, 2009-10-09
July, 2003 FDA 483 Bayer Healthcare, LLC - Form 483, 2003-07-07
April, 2010 FDA 483 Sgarlato Med, LLC - Form 483, 2010-04-05
August, 2001 EIR HDC Corporation - EIR, 2001-08-21
May, 2004 EIR Alza Corporation - EIR, 2004-07-12
June, 2004 EIR ALZA Corporation - EIR, 2004-07-12
December, 2010 FDA 483 ZOLL Circulation, Inc. - Form 483, 2010-12-14
June, 2005 FDA 483 Response Lifescan Inc - Form 483R, 2005-06-30
December, 2017 EIR Laser Dental Innovations - EIR, 2017-12-14
July, 2011 FDA 483 ZONARE Medical Systems, Inc. - Form 483, 2011-07-28
August, 2014 FDA 483 AccessClosure, Inc., A Cardinal Health Company - Form 483, 2014-08-05
September, 2011 FDA 483 Helio USA Inc - Form 483, 2011-09-26
December, 2011 FDA 483 Alexza Pharmaceuticals, Inc. - Form 483, 2011-12-12
January, 2002 FDA 483 Bio-Rad Laboratories Inc - Form 483, 2002-01-25
May, 2012 FDA 483 OcuMetrics, Inc. - Form 483, 2012-05-01
June, 2004 EIR ALZA Corporation - EIR, 2004-06-16
June, 2002 EIR Lifescan Inc - EIR, 2002-06-10
May, 2011 FDA 483 Accuray Incorporated - Form 483, 2011-05-10
May, 2009 FDA 483 Vertos Medical, Inc. - Form 483, 2009-05-26
September, 2002 EIR Becton Dickinson Medical (Singapore) - EIR, 2002-09-05
June, 2005 FDA 483 Lifescan Inc - Form 483, 2005-06-30
February, 2004 EIR Abbott Diabetes Care, Inc. - EIR, 2004-02-18
July, 2015 FDA 483 Agilent Technologies, Inc. - Form 483, 2015-07-06
July, 2001 FDA 483 Apical Instruments Inc - Form 483, 2001-07-18
May, 2000 FDA 483 Oxford Instruments Medical, LtD. - Form 483, 2000-05-19
June, 2001 EIR Abbott Vascular - EIR, 2001-06-19
July, 2009 FDA 483 Medtronic Advanced Energy LLC - Form 483, 2009-07-06
March, 2009 FDA 483 Abbott Diabetes Care, Inc. - Form 483, 2009-03-13
October, 2003 EIR Boston Scientific Corporation - EIR, 2003-10-07
May, 2003 EIR Varian Medical Systems, Inc. - EIR, 2003-05-29
January, 2004 EIR Lifescan Inc - EIR, 2004-01-15
November, 2010 FDA 483 Stellartech Research Corporation - Form 483, 2010-11-09
July, 2012 FDA 483 Medtronic Advanced Energy LLC - Form 483, 2012-07-03

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