FDA Investigator Mark E Chan

Mark E Chan has inspections in 15 countries as of 18 Oct 2023. Mark E Chan has collaborated with a combinined 3451 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
207
Last Inspection Date:
18 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100006193
Country:
Denmark, United States of America, Japan, Sweden, Taiwan, China, Belgium, Malaysia, Netherlands, Switzerland, Singapore, United Kingdom of Great Britain and Northern Ireland, Germany, Ireland
Co-Investigator(s):
A Williams, Adam S Freeman, Akbar J Zaidi, Alexandria L Capuano, Alla Dubrovsky, Althea A Williams, Amanda S Zorn, Amogh Pathi, Amy M Cramer, Andersoneric, 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, 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 Taharek, Gary L Zaharek, Gene D Arcy, George R Richards, Gerald N Mcgirl, DDS, Gulshan R Anand, Harjap K Atwal, Harperd, 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, Juan A Morales, Jude C Dikes, Kaarin M Slotte, Karen A Coleman, Karen D Phung, Karl D Hezel, 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 M De Souza, MBA, Larkin R Buckalew, Lauren E Skokan, Laverne Puckett, Lawton W Lum, LCDR Jennifer H Rhyu, Lee, Leo J Lagrotte, Leonard H Lavi, Linda Linh T Nguyen, 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, Mark E Chang, Mark F Chan, 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, Scott K Zika, Seema S Singh, Sergio Chavez (NMI), Sherri J Jackson, Stanley B Eugene, BS, BME, State Agency, 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
May, 2011 FDA 483 Accuray Incorporated - Form 483, 2011-05-10
November, 2002 FDA 483 Abbott Vascular, Inc. - Form 483, 2002-11-26
December, 2011 FDA 483 Alexza Pharmaceuticals, Inc. - Form 483, 2011-12-12
May, 2012 FDA 483 Covidien, LLC - Form 483, 2012-05-17
July, 2015 FDA 483 Agilent Technologies, Inc. - Form 483, 2015-07-06
July, 2011 FDA 483 ZONARE Medical Systems, Inc. - Form 483, 2011-07-28
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, 2000 EIR Oxford Instruments Medical, LtD. - EIR, 2000-05-19
November, 2010 FDA 483 Stellartech Research Corporation - Form 483, 2010-11-09
August, 2014 FDA 483 AccessClosure, Inc., A Cardinal Health Company - Form 483, 2014-08-05
March, 2009 FDA 483 Abbott Diabetes Care, Inc. - Form 483, 2009-03-13
October, 2003 EIR Boston Scientific Corporation - EIR, 2003-10-07
August, 2015 EIR Stellartech Research Corporation - EIR, 2015-08-20
May, 2015 FDA 483 Helio USA Inc - Form 483, 2015-05-12
April, 2019 FDA 483 Laser Dental Innovations - Form 483, 2019-04-18
June, 2002 FDA 483 Lifescan Inc - Form 483, 2002-06-10
September, 2003 EIR International Brachytherapy, s.a. (IBt) - EIR, 2003-09-04
August, 2003 FDA 483 Eldon Biologicals A/S - Form 483, 2003-08-27
October, 2003 FDA 483 Boston Scientific Corporation - Form 483, 2003-10-07
August, 2009 FDA 483 Penumbra Inc. - Form 483, 2009-08-28
July, 2003 FDA 483 Response Bayer Healthcare, LLC - Form 483R, 2003-07-28
April, 2015 EIR Olympus Corporation of the Americas - EIR, 2015-04-02
November, 2002 EIR Abbott Vascular, Inc. - EIR, 2002-11-26
January, 2002 FDA 483 Bio-Rad Laboratories Inc - Form 483, 2002-01-25
May, 2019 FDA 483 Zhejiang Runqiang Medical Instruments Co., Ltd. - Form 483, 2019-05-16
July, 2003 EIR Bayer Healthcare, LLC - EIR, 2003-07-07
August, 2003 EIR Eldon Biologicals A/S - EIR, 2003-08-27
July, 2003 EIR W. L. Gore & Associates, Inc. - EIR, 2003-07-24
October, 2009 FDA 483 Applied Ozone Systems - Form 483, 2009-10-09
May, 2012 FDA 483 OcuMetrics, Inc. - Form 483, 2012-05-01
June, 2003 EIR Calypte Biomedical Corp - EIR, 2003-06-05
February, 2016 EIR AccessClosure, Inc., A Cardinal Health Company - EIR, 2016-02-01
June, 2005 EIR Lifescan Inc - EIR, 2005-06-30
March, 2012 FDA 483 Chalgren Enterprises, Inc. - Form 483, 2012-03-28
July, 2009 FDA 483 Medtronic Advanced Energy LLC - Form 483, 2009-07-06
June, 2005 FDA 483 Lifescan Inc - Form 483, 2005-06-30
June, 2005 FDA 483 Response Lifescan Inc - Form 483R, 2005-06-30
June, 2004 EIR ALZA Corporation - EIR, 2004-06-16
December, 2017 EIR Laser Dental Innovations - EIR, 2017-12-14
September, 2003 FDA 483 International Brachytherapy, s.a. (IBt) - Form 483, 2003-09-04
September, 2011 FDA 483 Helio USA Inc - Form 483, 2011-09-26
May, 2009 FDA 483 Vertos Medical, Inc. - Form 483, 2009-05-26
June, 2004 FDA 483 ALZA Corporation - Form 483, 2004-06-16
December, 2017 FDA 483 Laser Dental Innovations - Form 483, 2017-12-14
May, 2015 FDA 483 Laax, Inc. - Form 483, 2015-05-22
September, 2015 FDA 483 I-see Vision Technology Inc - Form 483, 2015-09-10
August, 2001 EIR HDC Corporation - EIR, 2001-08-21
May, 2000 EIR Lewicki Microelectronic Gmbh - EIR, 2000-05-25
September, 2012 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2012-09-27
June, 2002 EIR Lifescan Inc - EIR, 2002-06-10
May, 2004 EIR Alza Corporation - EIR, 2004-05-14
June, 2004 EIR ALZA Corporation - EIR, 2004-07-12
September, 2002 EIR Becton Dickinson Medical (Singapore) - EIR, 2002-09-05
March, 2011 FDA 483 Stryker Corporation - Form 483, 2011-03-22
December, 2010 FDA 483 ZOLL Circulation, Inc. - Form 483, 2010-12-14
February, 2012 FDA 483 Angiodynamics Inc - Form 483, 2012-02-13
September, 2002 EIR Latexx Manufacturing Sdn Bhd - EIR, 2002-09-19
June, 2011 FDA 483 OroScience Inc. - Form 483, 2011-06-23
December, 2018 FDA 483 Duke Empirical Inc. - Form 483, 2018-12-21
July, 2001 FDA 483 Apical Instruments Inc - Form 483, 2001-07-18
January, 2004 EIR Lifescan Inc - EIR, 2004-01-15
May, 2000 FDA 483 OXFORD INSTRUMENTS MEDICAL LTD. - Form 483, 2000-05-19
April, 2010 FDA 483 Sgarlato Med, LLC - Form 483, 2010-04-05
January, 2000 EIR Medtronic Vascular, Inc. - EIR, 2000-01-12
May, 2003 EIR Varian Medical Systems, Inc. - EIR, 2003-05-29
June, 2001 EIR Abbott Vascular - EIR, 2001-06-19
September, 2008 EIR DePuy (Ireland) - EIR, 2008-09-11
November, 2012 FDA 483 Alexza Pharmaceuticals, Inc. - Form 483, 2012-11-08
May, 2019 FDA 483 Shenzhen Jiacom Technology Co., Ltd - Form 483, 2019-05-09
July, 2003 FDA 483 Bayer Healthcare, LLC - Form 483, 2003-07-07
October, 2011 FDA 483 Intraop Medical Corporation - Form 483, 2011-10-06
November, 2015 FDA 483 Pulsar Vascular Inc. - Form 483, 2015-11-13
August, 2001 FDA 483 HDC Corporation - Form 483, 2001-08-21
July, 2013 FDA 483 Haas Software - Form 483, 2013-07-10
January, 2007 FDA 483 Intuitive Surgical, Inc. - Form 483, 2007-01-09
February, 2004 EIR Abbott Diabetes Care, Inc. - EIR, 2004-02-18
June, 2004 FDA 483 ALZA Corporation - Form 483, 2004-05-14
July, 2012 FDA 483 Medtronic Advanced Energy LLC - Form 483, 2012-07-03
April, 2013 FDA 483 Hotspur Technologies - Form 483, 2013-04-05

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