FDA Investigator Carl Lee

Carl Lee has inspections in 9 countries as of 27 Oct 2023. Carl Lee has collaborated with a combinined 6727 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
139
Last Inspection Date:
27 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, China, Japan, Thailand, India, Denmark, Germany, Hungary
Co-Investigator(s):
A Williams, Abha R Bommireddi, Adam S Freeman, Alan P Kurtzberg, Albinus M D Sa, Alexandra M Cossi, Alice A Blair, Alicia Gilbert, Alicia K Mckinsey, Alla Dubrovsky, Almogela, Amir Alavi, Ana Maria Osorio, MD, Anastasia M Shields, Andrea A Branche, Andrea George, PhD, Andrea P Scott, Andrei Perlloni, Andrew B Slarve, Andrew Chang, Andrew K Haack, PhD, Andrew T Todd, Andrew Tadros, Andrew W Harmon, Angel K Sandhu, Angela D Wise, Anh M Lac, Anita Narula, PhD, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Ashar P Parikh, Atul J Agrawal, Avery J Dennis, Barbara J Arrais, Barbara J Wilcox, PhD, Bernice F Hirsch, Bo Chi, PhD, Bonita S Chester, Brandi N Mcgrady, Brenda W Uratani, PhD, Brett W Podoski, Brian R Henderson, Bruce D Broidy, Calvin B Koerner, Candace Y Gomez Broughton, Capri R Woolridge, Carol A Llewellyn, Carole L Jones, Carolyn A Renshaw, Carr, Caryn M Everly, Caryn M Mcnab, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Celeste K Wong, Charles I Ann, Charles M Edwards, Chloe Anne Leong, Christian D Lynch (CDL), Christine M Parmentier, Christopher D Leach, Christopher R Czajka, Christopher T Middendorf, Chyla T Hunter, Cindy W Lewis, Courtney R Bolton, Cynthia Jim, CSO, Damon A Growl, Daniel C Geffin, Daniel J Roberts, Daniel Lagasse, Daniel Velasquez, Darren S Brown, David A Lum, David G Eng, Dena L Jacobs, Devaughn Edwards, Diane Cvan Leeuwen, Djamila Harouaka, Dongping Dai, PhD, Dr. Gang Wang, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Zhou Chen (nmi), MD PhD, Dustin P Tran, Dustin R Abaonza, Edith M Gonzalez, Edna J Hidalgo, Edward D Harris, Edward J Janik, Eileen A Liu, Elaine S Chow, Elisabeth A Drevet, Elizabeth A Dakan, Elizabeth Juarez, Elmina E Akwo, Elsa Y Yu, Emal Wahab, Emest F Bizjak, Emily Shacter, Emmanuel Adu Gyamfi, Eric L Dong, BS, Eric M Mueller, PharmD, Erica Fernandez, Erica L Nicoll, Erica R Pomeroy, Ethan P Stegman, Francis A Guidry, Francis J Eng, Frank P Bianco, Gerald Feldman, Gerald M Feldman, PhD, Gerald N Mcgirl, DDS, Geraldine D Sanders, Geraldine Sanders, Gina M Hall, Glen E Harelson, Gunneet Kaur, Gwyn G Dickinson, Harry J Brewer, Helen B Ricalde, Helen J Hamaoka, Henry K Lau, Henry X Lau, Hung H Do, MS, Huy T Pham, Ingrid A Zambrana, Italia Nappi, Ivis Lnegron Torres, Jacqueline Mdiaz Albertini, James A Lane, James C Lee, PharmD, James C Yee, James R Evans, Jamie P Webb, Jane Chen, Jane L Chang, Jane M Kreis, Janice K Gardner, Janice R Small, Janice Wai, Jawaid Hamid, Jazmine M Welcher, Jeanmaire Hryshko, Jeanne A Young, Jeanne Fringer, PhD, Jeffrey D Meng, Jeffrey M Watson, Jeffrey W Shrifter, DPM, Jennifer L Degroot, Jennifer L Johnson, Jennifer Lalama, Jennifer S King, Jessica B Darneille, Joan T Briones, Joanne Hosting, Jocelyn T Ramos, Jogy George, John A Gonzalez, John A Liu, John D White, John Fox, Jolanna A Norton, Jolene S Hedgecock, Jorge L Guadalupe, Jose Alopez Rubet, Jose E Melendez, DDC, Jose R Hernandez, Joseph A Seitz, Joseph George, Joseph Kutze, PhD, Joseph P Iser, MD, Joshua S Hunt, Joslyn K Brunelle, PhD, Juan A Morales, Jude C Dikes, Juliane Kjung Lau, Julie D Bringger, Justin A Boyd, Kacie M Crowther, Karen D Phung, Karla J Gibler, Karlygash I Yermukan, Karyn M Campbell, Kathryn E King, Katie T Duong, Keith O Webber, PhD, Keith Webber, PhD, Kellia N Hicks, Kenneth O Gee, PhD, Kenya Destin, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberlee Wood, Kouros Kangarli, Kristin M Abaonza, Kula N Jha, Lakisha M Williams, Lance M De Souza, MBA, Larkin R Buckalew, Larry K Austin, Latorie S Jones, Laura Fontan, MS, Laurie Graham, Laurie P Norwood, Laverne Puckett, Lawton W Lum, LCDR Jennifer H Rhyu, Leongc, Lija V Fellows, Lillie D Witcher, Linan Ha, PhD, Linda F Gilchrist, Linda F Murphy, Linda S Shook, Linda Thai, Linh Tu, Lisa R Hilliar, Lorna F Jones, Lorraine N Williams, Lucas B Leake, Lucila B Nwatu, Luis A Dasta, Lynda L Perry, PhD, Mabel M Lee, Macropolk, Maida Henesian (NMI), Marcus A Ray, Margo Cl Jones, Maridali De Leon Torres, Marie K Kinkade, Marijo B Kambere, PhD, Mariza M Jafary, Mark E Baldwin, Mark E Chan, Mark I Nakano, Marsha W Major, Marshalette Edwards, Marshalette O Edwards, Mary C Acton, Mary C Wall, Mary K Kinkade, Mary R Hole, Matthew B Casale, Matthew K Wong, Matthew R Clabeaux, Megan E Kulas, Melody M Ragasa Leong, Michael A Charles, Michael L Casner, Michael L Chasey, Michael O Skidmore, Michael R Goga, Michael S Smoker, Michael Shanks, MS, Michele L Obert, Michelle L Tripp, Michelle Rfrazier Jessen, PhD, Miguel A Martinez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Min Shanma Liu, Monique C Lo, Mra Davism, Mra Munizn, Muralidhara B Gavini, PhD, Nancy E Kirschbaum, Nancy G Schmidt, Nancy T Waites, Natalia Pripuzova, PhD, Nayan J Patel, Nayan Patel, Neal L Adams, Nicholas L Hunt, Nicholas Obiri, PhD, Nicole Yuen, Nympha V Florendo, Omotunde O Osunsanmi, Parul M Patel, Patricia F Hughes, PhD, Paul A Bonneau, Paul E Stein, Paula A Trost, Paula J Bretz, Peter E Baker, Peter Kessler, PhD, Phung, Prabhu P Raju, Qing Joanna Zhou, PhD, Quynh H Strandberg, Rachel C Harrington, Ralph A Erickson, Randall P Zielinski, Ravi S Harapanhalli, Raymond Souweha, Raymond T Oji, Reba A Gates, Rebecca E Sulpacio, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Reyes Candau Chacon, PhD, Richard W Thornton, Riley C Myers, PhD, Robert D Tollefsen, Robert W Jennings, Roberta K Smith, Roger D Gawne, Roman Drews, PhD, Roman T Drews, PhD, Ronald P Boyce, Rose Xu, Rumany C Penn, PharmD, Russell J Glapion, Ruth Moore, PhD, Sandra S Saniga, Sangeeta M Khurana, PhD, Satheesh Thomas, Scott N Lim, Sean P Desbrow, Seema S Singh, Serge Beaucage, Sergio Chavez (NMI), Seyyida Saterfield, Sharon K Thoma, PharmD, Sharon K Thomas, Sharon L Shane, Shelley H Beausoleil, Sherri J Jackson, Sidney B Priesmeyer, Simone E Pitts, Siobhan A Gallagher, Sixto M Mercado Rios, State Agency, Stephanie A Slater, MS, Steven B Chiu, Steven R Gillenwater, Stuart W Russell, Susan F Laska, MS, Susan M Jackson, Susan W Ting, Syed N Ali, Tamil Arasu, PhD, Ted L Anderson, Temar Q Williams, Terrence Gee, Terri L Dodds, Terry A Hook, DPh, Thaddeus T Sze, Thea C Grome, Thomas J Arista, Thomas N Adjabeng, Thomas R Withers, Thomas W Gordon, Thuy T Nguyen, LCDR, Timothy C Grome, Timothy T Kapsala, Todd M Bozicevich, Tracey L Harris, Tracy K Li, Travelle D Mason, Truong Xuan Nguyen (Andy), Uduak M Inokon, Uttaniti Limchumroon (Tom), Vebina K Sethi, Vijaya L Simhadri, Walden H Lee, Wen Jun Peng, Wen Ning Chan (Sally), Willemsj, William J Foust, William J Weis, William V Millar, Yen Tso Kuo, Yi Wang, PhD, Ying Xin Fan, PhD, Yiyue Zhang (nmi), PhD, Zi Qiang Gu, Zuben E Sauna, PhD

Carl Lee's Documents

Publish Date Document Type Title
June, 2006 FDA 483 Prescript Pharmaceuticals, Inc. - Form 483, 2006-06-12
September, 2003 EIR Taylor-Wright Pharmacal - EIR, 2003-09-30
September, 2003 FDA 483 Green Products Company - Form 483, 2003-09-30
July, 2002 EIR Airgas Usa, LLC - EIR, 2002-07-16
September, 2003 FDA 483 PharmPak, Inc. - Form 483, 2003-09-03
October, 2002 EIR Onyx Pharmaceuticals, Inc. - EIR, 2002-10-22
April, 2013 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2013-04-26
August, 2003 FDA 483 Prescript Pharmaceuticals, Inc. - Form 483, 2003-08-11
August, 2003 EIR Prescript Pharmaceuticals, Inc. - EIR, 2003-08-11
December, 2000 FDA 483 Sunopta - Form 483, 2000-12-01
July, 2003 EIR RPK Pharmaceuticals, Inc. - EIR, 2003-07-16
March, 2014 EIR China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. - EIR, 2014-03-28
June, 2003 FDA 483 Ray Drug Co Inc - Form 483, 2003-06-16
April, 2006 FDA 483 Mylan Specialty, L.P. - Form 483, 2006-04-26
March, 2002 EIR Bayer HealthCare LLC - EIR, 2002-03-15
September, 2003 EIR PharmPak, Inc. - EIR, 2003-09-03
March, 2014 FDA 483 China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. - Form 483, 2014-03-28
October, 2002 FDA 483 Onyx Pharmaceuticals, Inc. - Form 483, 2002-10-22
January, 2008 FDA 483 Molecular Imaging Program At Stanford - Form 483, 2008-01-31
July, 2002 FDA 483 Airgas Usa, LLC - Form 483, 2002-07-16
May, 2005 FDA 483 ABCO Laboratories, Inc - Form 483, 2005-05-31
March, 2002 FDA 483 Bayer HealthCare LLC - Form 483, 2002-03-15
December, 2001 FDA 483 Prima Fleur Botanicals Inc - Form 483, 2001-12-20
May, 2004 FDA 483 MBI Distributing, Inc - Form 483, 2004-05-04
July, 2003 FDA 483 RPK Pharmaceuticals, Inc. - Form 483, 2003-07-16
September, 2003 EIR Taylor Wright Pharmacals Inc - EIR, 2003-09-26
September, 2002 EIR Genentech, Inc. - EIR, 2002-09-13
February, 2004 FDA 483 Genentech, Inc. - Form 483, 2004-02-13
March, 2005 FDA 483 MBI Distributing, Inc - Form 483, 2005-03-08
December, 2001 EIR Harris, Steven T., M.D. - EIR, 2001-12-07
July, 2004 EIR Impax Laboratories, LLC. - EIR, 2004-07-29
March, 2014 FDA 483 Yibin Lihao Bio-technical Co., Ltd. - Form 483, 2014-03-05
February, 2004 EIR Genentech, Inc. - EIR, 2004-02-13
June, 2011 FDA 483 Genentech, Inc. - Form 483, 2011-06-23
September, 2002 EIR Stiefel Laboratories Inc - EIR, 2002-09-04

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

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