FDA Investigator Diane Cvan Leeuwen

Diane Cvan Leeuwen has inspections in 15 countries as of 13 Oct 2023. Diane Cvan Leeuwen has collaborated with a combinined 6217 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
283
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100001512
Country:
United States of America, Netherlands, France, Russian Federation, Germany, Australia, Denmark, Switzerland, Canada, Indonesia, Portugal, Greece, United Kingdom of Great Britain and Northern Ireland, Japan
Co-Investigator(s):
A Williams, Aaron J Adler, Alan P Kurtzberg, Albert Rodriguez, Alexandra B Pitkin, Alexandria L Capuano, Allen F Hall, Alyson C Tanner, Amalia C Himaya, Amalia Himaya, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Anderson, Andrew Le, Angela Shepas, Angele C Smith, Anh M Lac, Anita Narula, PhD, April P Shaw, Arie C Menachem, Arindam Dasgupta, PhD, Armando Chavez, MS, Arsen Karapetyan, Ashar P Parikh, Babajide Michael Osunsanmi, Barry Cherney, PhD, Bei Yu, Bichsa T Nguyen, Bichsa T Tran, Binh T Nguyen, Bo Chi, PhD, Bonnie I Needleman, Bowman, Brian J Ryan, Brian P Putz, Brian S Keefer, Brien C Fox, Bryan A Galvez, Bryce A Hammer, Carl Lee, Carla J Lundi, Carr Sharpe, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cecilia H Kieu, Celena Ngo, Charles L Larson, Chelsea N Sealey, Cheron M Portee, Cheryl D Mccall, Chong Ming Cheng, Chorng M Cheng, Christina D Mello, Christina V Santos, Christopher D Washington, Christopher R Czajka, Claudia Mperez Kasmarski, Comyar Shoghi, Courtney N Long, Cynthia J Lee, MS, Cynthia L Gorveatt, Daniel J Roberts, Daniel W Cline, Darren S Brown, David G Whitman, David Y Hernandez, Davinna Ligons, PhD, Davis, Deborah A Greco, Debra J Fracassa, Dejon N Harris, Diana M Rand, Diance Cvan Leeuwen, Diane C Vaneeuwen, Doan T Nguyen, PharmD, Donna Ltartaglino Besone, Donna Mwilliams Hill, Dr. Chunchang Fang, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Durell L Giles, Dustin R Abaonza, Elaine A Bunch, Erin L Mcfiren, Esther B Gamallo Herrera, Esther Bgamello Herrera, Evelyn Wong, Finn A Slizza, Frances Namuswe, PhD, Francisco, Frederick L Fricke, Gajendiran Mahadevan, PhD, Garciam, Gene D Arcy, Gene Matienzo, Gerald N Mcgirl, DDS, Grace P Santos, Greg K Keshishyan, Gunneet Kaur, Haley H Seymour, Haley Seymour, Haroon Vohra (NMI), Harperd, Hasan A Irier, PhD, Heika R Tait, Henry E Carrillo, Herminio C Francisco, Hoover, Humberto Z Gomez, Hung H Do, MS, Iram R Hassan, PhD, Iris C Macinnes, Ivar J Sohn, Jacob W Reynolds, James A Barreto, James M Kewley, James P Mcevoy, James P Stallings, James P Stumpff, James R Fleckenstein, Jane M Kreis, Janet Pulver, Jasmine N Thompson, Jazmine M Welcher, Jee Chung, PhD, Jeff M Uriarte, Jeffrey M Watson, Jeffrey P Raimondi, Jeffrey W Shrifter, DPM, Jennie J Fan, Jennifer Gogley, Jennifer L Degroot, Jennifer L Johnson, Jennifer M Gogley, Jinnie Kokiatkulkij, Jocelyn E Massey, Jocelyn E Sparks, Joe X Phillips, Joel D Hustedt, Joel D Martinez, Joel Welch, PhD, Joey V Quitania, Johann M Fitch, John A Gonzalez, John Cheng (NMI), John L Stevens, John P Jorgensen, John R Myung, Jolanna A Norton, Joseph C Yen, Joshua J Silvestri, Juanita Banuelos, Judy C Nepsa, Julian C Hanson, Jun Park, PhD, Justin A Boyd, Ka L Wong, Kaitlyn T Dang, Karen A Wolnik, Karen M Cooper, Karen P Langer, Katherine E Jacobitz, Kathleen B Swat, Kathleen R Jones, PhD, Kelley, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kevin Lee, Kevin N Tran, Kevin P Foley, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberly M Lichter, Kirsten S Tharp, Kirtida Patel, Kristin M Abaonza, Ks Tharp, Lakecha N Lewis, Lance A Finnical, Lance M De Souza, MBA, Langer, Lanita F Kelley, Laura Fontan, MS, Lavender M Huskey, Laverne Kimble, LCDR Jennifer H Rhyu, Leonard H Lavi, Lequita M Mayhew, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda M Cheny, Linda Thai, Lisa A Doyle, Lisa Shin, Lynette M Terry, M Jasnethoson Thompson, Mageet, Marcia Britt Williams, Marcus F Yambot, Maria C Agpaoa, Maria C Fermin, Marie K Kinkade, Marie T Falcone, Marilyn S Babu, Mariza M Jafary, Mark C Saale, Mark E Chan, Mark Gray, Martin K Yau, PhD, Mary Ewilkerson Brinsko, Mary K Kinkade, Mathew T Thomas, MD, Matthew R Clabeaux, Maxyne T Lam, Mei Chen Mu, Melkamu Getie Kebtie, PhD, Mendoza O Wallace, Michael D Garcia, Michael D Skelly, PhD, Michael F Skelly, PhD, Michael P Sheehan, Michael S Araneta, Michael S Call, Michael T Cyrus, Michelle A Marsh, Michelle J Hines, Mihaly S Ligmond, Minh D Phan, Mohsen Rajabi Abhari, FDA, Monica R Maxwell, Nabeela J Chaudhry, Nancy A Bellamy, Natalie J Ayoub, Natalie J Reese, Nayan J Patel, Nelly N Tran, Ni A Khin, MD, Nicholas L Hunt, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Norman Wong, Omotunde O Osunsanmi, Paquita F Segarra, Patrick D Stone, MS, Peter E Baker, Peter Kessler, PhD, Peter S Diak, Phal K Chhun, Phillip L Toy, Rafael A Kaup, Randall N Johnson, Raymond W Brullo, Rebecca Rodriguez, Richard W Tubb, Richmond K Yip, Robert C Hoover, Robert D Tollefsen, Robert Darius, Robert S Sweeton, Robert T Lorenz, Rochelle A Rolnik, Rocio Guzman Velazquez, Roger F Zabinski, Ronald L Koller, Ronda Lebland, Ronda R Loyd Jones, Rowena S Nguyen, Roy R Rinc, Rumany C Penn, PharmD, Russell R La Claire, Ruth A Williams, Saied A Asbagh, Samson O Oluseye, Sandra A Hughes, Sandra L Shire, DMD, MPA, Sandra S Saniga, Santiago Gallardo Johnson, Sara Jdent Acosta, Sarah A Hassas, Sarah Arden, Scott K Zika, Scott R Nichols, PhD, Sean P Desbrow, Selene T Torres, Sharon K Thoma, PharmD, Sharon K Thomas, Sharon L Matson, Sherri N Rohlf, MD, Sidney B Priesmeyer, Sidonie J Takougang, Sonia R Peterson, Sonya L Karsik, Stanley Au, State Agency, Stephanie A Slater, MS, Steven E Porter, Jr, Steven Eastham, Steven Fong, MS, PhD, Stuart W Russell, Sundy V Sedwick, Sundy Ven, Sunitha K Rajaram, PhD, Susan M Matthias, Susanna N Choi, Susanne M Richardson, MSc RAC ELS, Taichun Qin, PhD, Tamala P Bogan, Tamala P Magee, Tamara L Ely, Tania Y Hall, Tawny L Colling, Teena H Aiken, Teresa T Cain, Terrance L Thomas, Terri L Dodds, Thanh M Andrews, Thao T Kwan, Thao Tran, Thao X Tran, That T Kwan, Theresa Kirkham (NMI), Thomas R Beilke, Timothy P Lafave, Tracey T Duong, Trudy Papson, Trudy R Papson, Truong Xuan Nguyen (Andy), Trushani T Desai, Trushani T Shah, Uttaniti Limchumroon (Tom), Valerie L Whipp, Vasant G Malshet, PhD, Vashti E Bocker, Vickie L Anderson, Victor H Loo, Victoria A Wagoner, Vien Q Le, Virgilio F Pacio, CSO, Walden H Lee, Wayne L Jefferson, Wenzheng Zhang, William J Leonard, William S Vitale, Yasamin Ameri, Youkeun Kim, Yumi J Hiramine, Yvette E Guillermo, Yvette Mlacour Davis, Yvins Dezan, Yvonne C Wilkes, Yvonne T Lacour, Zachary A Bogorad, Zachary L Miller

Diane Cvan Leeuwen's Documents

Publish Date Document Type Title
August, 2009 FDA 483 Response Sant P. Chawla, MD - Form 483R, 2009-09-14
March, 2009 EIR Charles R. McKay, MD - EIR, 2009-03-06
June, 2015 EIR James L. Pearle, MD - EIR, 2015-06-11
October, 2021 FDA 483 Valley Biosystems - Form 483, 2021-10-08
August, 2018 FDA 483 Stephen G. Thein, Ph.D. - Form 483, 2018-08-03
August, 2002 EIR Harris, Barbara A - EIR, 2002-08-05
February, 2019 FDA 483 Tran-Johnson, Tram K. - Form 483, 2019-02-01
May, 2003 EIR Heiser Jon F MD - EIR, 2003-05-07
February, 2014 EIR SigmaGraft Inc - EIR, 2014-02-11
January, 2000 EIR Martin, Dale E MD - EIR, 2000-01-14
June, 2002 FDA 483 Kovacs, Gabor S MD - Form 483, 2002-06-14
May, 2016 FDA 483 Spectrum Pharmaceuticals, Inc. - Form 483, 2016-05-27
September, 2000 FDA 483 Response Quest Diagnostics - Form 483R, 2001-02-15
April, 2015 EIR International Cellular Medicine Society IRB - EIR, 2015-04-17
July, 2015 FDA 483 Response Thomas S. Tooma, M.D. - Form 483R, 2015-08-04
May, 2002 EIR NUVISAN GmbH - EIR, 2002-09-09
January, 2002 EIR Dr. Theodore C. Monchesky - EIR, 2002-01-23
December, 2000 FDA 483 Tera Pharmaceuticals Inc - Form 483, 2000-12-08
January, 2016 FDA 483 Synergy Health Concepts, Inc. - Form 483, 2016-01-28
August, 2001 EIR Mclinn, Samuel E - EIR, 2001-08-24
March, 2009 FDA 483 Charles R. McKay, MD - Form 483, 2009-03-06
June, 2001 EIR Pinnas, Jacob L Md - EIR, 2001-06-14
October, 2016 FDA 483 Monica M. Mita, MD, MSc, Clinical Investigator - Form 483, 2016-10-24
July, 2018 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2018-07-17
August, 2018 EIR Stephen G. Thein, Ph.D. - EIR, 2018-08-03
August, 2009 FDA 483 Sant P. Chawla, MD - Form 483, 2009-08-27
August, 2013 FDA 483 Sanitor Corporation - Form 483, 2013-08-15
January, 2017 FDA 483 Apinya B. Vutikullird, D.O. - Form 483, 2017-01-24
July, 2016 FDA 483 Targeted Medical Pharma, Inc. dba Physician Therapeutics - Form 483, 2016-07-01
May, 2000 EIR Dennis S. Riff, M.D. - EIR, 2000-05-15
November, 2016 FDA 483 Steven-Huy B. Han, M.D. - Form 483, 2016-11-23
September, 2000 FDA 483 Quest Diagnostics - Form 483, 2000-09-14
March, 2013 EIR Allergan Sales, LLC - EIR, 2013-03-21
June, 2018 FDA 483 Ignatius P. Godoy, M.D. - Form 483, 2018-06-11
August, 2001 FDA 483 Mclinn, Samuel E - Form 483, 2001-08-24
November, 2012 FDA 483 Mark B Faries, MD - Form 483, 2012-11-30
July, 2012 FDA 483 Blaine Labs Inc. - Form 483, 2012-07-23
May, 2011 EIR Carlsbad Technology, Inc. - EIR, 2011-05-26
March, 2015 FDA 483 Raffi R. Minasian, M.D. - Form 483, 2015-03-10
February, 2014 FDA 483 SigmaGraft Inc - Form 483, 2014-02-11
December, 2013 EIR Allergan Sales, LLC - EIR, 2013-12-23
August, 2009 EIR Sant P. Chawla, MD - EIR, 2009-08-27
May, 2013 EIR Johnson & Johnson Consumer Inc. - EIR, 2013-05-16
July, 2016 FDA 483 Response Richard S. Finn, M.D. - Form 483R, 2016-08-15
December, 2014 FDA 483 Dr. Yann Godbert - Form 483, 2014-12-05
March, 2015 FDA 483 Mohamed A. El-Shahawy, M.D. - Form 483, 2015-03-19
May, 2001 FDA 483 Response Sokol, William N., M.D. - Form 483R, 2001-05-18
March, 2013 FDA 483 Allergan Sales, LLC - Form 483, 2013-03-21
March, 2011 FDA 483 Caribia, Inc - Form 483, 2011-03-07
August, 2002 FDA 483 Barbara A. Harris, Ph.D. - Form 483, 2002-08-05
November, 2013 FDA 483 Carlos H. Montenegro, MD - Form 483, 2013-11-22
November, 2016 FDA 483 Axis Clinical Trials - Form 483, 2016-11-30
August, 2022 FDA 483 Michael E. Gottschalk, M.D. - Form 483, 2022-08-05
June, 2012 FDA 483 Diane J Nugent MD - Form 483, 2012-06-22
July, 2016 FDA 483 Richard S. Finn, M.D. - Form 483, 2016-07-27
February, 2017 FDA 483 Yutaka Niihara, M.D., MPH - Form 483, 2017-02-13
March, 2015 EIR Mohamed A. El-Shahawy, M.D. - EIR, 2015-03-19
November, 2002 EIR Allergan Sales, LLC - EIR, 2013-07-26
May, 2001 EIR Sokol, William N., M.D. - EIR, 2001-05-09
July, 2016 FDA 483 Response Targeted Medical Pharma, Inc. dba Physician Therapeutics - Form 483R, 2016-07-18
June, 2001 EIR Myers, Robert A - EIR, 2001-06-22
September, 2000 EIR Quest Diagnostics - EIR, 2001-01-11
March, 2000 EIR David Feifel MD - EIR, 2000-03-17
April, 2000 EIR Steven L. Duckor, M.D. - EIR, 2000-04-27
February, 2000 EIR Dennis A Goodman MD - EIR, 2000-02-24
May, 2012 FDA 483 University of California Irvine Brain Imaging Center - Form 483, 2012-05-03
April, 2005 EIR Allergan Sales, LLC - EIR, 2005-04-22
June, 2015 FDA 483 James L. Pearle, MD - Form 483, 2015-06-11
May, 2001 FDA 483 William N. Sokol, M.D. - Form 483, 2001-05-09
March, 2015 FDA 483 Response Raffi R. Minasian, M.D. - Form 483R, 2015-03-26
July, 2000 FDA 483 Dr. John C. Hoefs, M.D. - Form 483, 2000-07-28
September, 2000 EIR Allergan Inc - EIR, 2000-09-26
July, 2016 EIR Richard S. Finn, M.D. - EIR, 2016-07-27
June, 2010 FDA 483 McGuff Pharmaceuticals, Inc. - Form 483, 2010-06-02
June, 2018 FDA 483 Response Ignatius P. Godoy, M.D. - Form 483R, 2018-06-22
June, 2002 EIR Kovacs, Gabor S MD - EIR, 2002-06-14
December, 2003 EIR DeSilva, Himasiri - EIR, 2003-12-03
July, 2000 FDA 483 Response Hoefs, John C MD - Form 483R, 2000-08-21
November, 2013 EIR Carlos H. Montenegro, MD - EIR, 2013-11-22
June, 2018 EIR Ignatius P. Godoy, M.D. - EIR, 2018-06-08
November, 2013 FDA 483 Response Carlos H. Montenegro, MD - Form 483R, 2013-12-03
July, 2015 EIR Thomas S. Tooma, M.D. - EIR, 2015-07-17
July, 2015 FDA 483 Thomas S. Tooma, M.D. - Form 483, 2015-07-17
July, 2000 EIR Hoefs, John C MD - EIR, 2000-07-28
March, 2001 EIR B. Braun Medical Inc - EIR, 2001-03-15
October, 2003 FDA 483 Noli R. Zosa, MD - Form 483, 2003-10-16
June, 2001 FDA 483 Myers, Robert A - Form 483, 2001-06-22
July, 2014 EIR Leo Mascarenhas, MD - EIR, 2014-07-01
November, 2019 FDA 483 Maria W. Greenwald, MD - Form 483, 2019-11-01

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.

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