FDA Investigator Lance Mde Souza, MBA

Lance Mde Souza, MBA has conducted inspections on 140 sites in 9 countries as of 02 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
140
Last Inspection Date:
02 May 2024
Investigator Role:
FDA Investigator
Redica ID:
100004841
Countries of Inspections:
United States of America, France, Switzerland, Ireland, India, Italy, Hungary, Germany, United Kingdom of Great Britain and Northern Ireland
FDA Investigators that have inspected at least one site in common with Lance Mde Souza, MBA:
Aaron M Weisbuch, Abdur Razzaque, Adam S Freeman, Alan L Truong, Alicia K Mckinsey, Alison A Nicoli, Alla Dubrovsky, Amir Alavi, Amy M Cramer, Ana Maria Osorio, MD, Anastasia I Offordile, Anastasia I Onuorah, Andrea A Branche, Andrea George, PhD, Andrei Perlloni, Andrew B Slarve, Andrew P Lin, Andrew W Harmon, Angel K Sandhu, Anh M Lac, Anita Narula, PhD, Anita R Michael, Anna Lazar, Annika M Niles, Anthony E Keller, RPh, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Ashar P Parikh, Azza Talaat, Barbara J Wilcox, PhD, Barbara M Frazier, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Bradley J Maunder, Breena L D'ambrogi, Brentley S Collins, Bruce D Broidy, Calvin B Koerner, Candace Y Gomez Broughton, Carl Lee, Carole L Jones, Carolyn A Renshaw, Caryn M Mcnab, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Celeste K Wong, Christian D Lynch (CDL), Christine M Parmentier, Christopher R Czajka, Cindy W Lewis, Claudia Mperez Kasmarski, Constance Y Fears, Courtney N Long, Courtney R Bolton, Cynthia A Palmer, Cynthia J Tsui, Cynthia Jim, CSO, Damon A Growl, Dandan Wang, PhD, Daniel C Geffin, Daniel J Roberts, Darlene B Almogela, Darren S Brown, David A Lum, David D Anderson, PhD, David G Eng, David R Heiar, Denise M Digiulio, Diane Cvan Leeuwen, Diane L Raccasi, Dipti Kalra, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Douglas A Campbell, Dr. Abhijit Raha, PhD, Dr. Barbara D Paul, PhD, Dr. Guang Gao, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Zhou Chen (nmi), MD PhD, Dustin P Tran, Dustin R Abaonza, Edna J Hidalgo, Edward D Harris, Edward R Schiffman, Eileen A Liu, Elaine S Chow, Elizabeth Juarez, Elizabeth S Furukawa, Emily Shacter, Emmanuel Adu Gyamfi, PhD, Ephrem Hunde, PhD, Eric L Dong, BS, Eric M Mueller, PharmD, Eric W Anderson, Erica L Nicoll, Erica R Pomeroy, Felix Maldonado, Francis J Eng, Frank P Bianco, Gabrielle J Swain, Gayle S Lawson, Gene D Arcy, Gerald Feldman, Gerald M Feldman, PhD, Gerald N Mcgirl, DDS, Gerard Pde Leon, Gina M Hall, Glen E Harelson, Guerlain Ulysse, Gulshan R Anand, Gunneet Kaur, Gwyn G Dickinson, Hala L Selby, Hala Lj Whetstone, Haley H Seymour, Henry K Lau, Humberto Z Gomez, Hung H Do, MS, Huy T Pham, Ingrid A Zambrana, Italia Nappi, Ivis L Negron, Jacqueline Mdiaz Albertini, James A Lane, James C Lee, PharmD, James C Yee, James R Evans, Jane G Choi, Jane M Kreis, Janete F Guardia, Janice Wai, Jason K Morgan, Jawaid Hamid, Jeanne A Young, Jeanne Fringer, PhD, Jeanne J Thai, Jeffrey M Watson, Jeffrey P Raimondi, Jeffrey W Shrifter, DPM, Jennifer A Hickey, Jennifer Crumb, Jennifer L Degroot, Jennifer L Johnson, Jeremy W Rotton, Joan T Briones, Joanne Hosting, Joanne M Schlossin, Jocelyn T Ramos, Joel D Martinez, Joey V Quitania, John A Gonzalez, John A Liu, John Cook, Jolanna A Norton, Jolene S Hedgecock, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Joseph A Seitz, III, Joseph Kutze, PhD, Joseph P Iser, MD, Joshua S Hunt, Joslyn K Brunelle, PhD, Juan A Morales, Jude C Dikes, Juliane Kjung Lau, Julianne C Mccullough, Junho Pak, Karen A Briggs, Karen D Phung, Karen L Robles, Karen M Montgomery (KMM), Karlygash I Yermukan, Kathryn E King, Katie L Penno, Keith O Webber, PhD, Keith Webber, PhD, Kendra A Biddick, Kendra L Brooks, Kenneth O Gee, PhD, Kenneth S Boehnen, Keren Arkin, Kevin P Foley, Kim Lthomas Cruse, Ko U Min, Kouros Kangarli, Kristin M Abaonza, Kula N Jha, Lakisha M Williams, Lakshmi Narasimhan, PhD, Larkin R Buckalew, Larry K Austin, Laura Fontan, MS, Lauren E Swantko, Laurie Graham, Laurie P Norwood, Lawton W Lum, LCDR Chad N Thompson, LCDR Jennifer H Rhyu, Lealand Lee, Leonard H Lavi, Lija V Fellows, Linan Ha, PhD, Linda F Murphy, Linda M Hoover, Linh Tu, Lisa M Bellows, Lorna F Jones, Lorraine M Humes, Lucila B Nwatu, Lydia S Chan, Lynda L Perry, PhD, Lynn L Wong, Mabel M Lee, Maida Henesian (NMI), Marcus F Yambot, Margaret M Annes, Maria Cruz Fisher, Maridali Deleon Torres, Marie K Kinkade, Mariza M Jafary, Mark E Chan, Mark I Nakano, Marsha W Major, Marshalette O Edwards, Mary C Acton, Matthew A Walburger, Matthew B Casale, Matthew R Clabeaux, Meena Bansal Gupta, PhD, Mei Chiung Huang (Jo), Meisha R Sampson, Meisha Waters, Melanie M Walker, Michael D Kawalek, Michael R Klapal, Michael Shanks, MS, Michael T Cyrus, Michele Gottshall, Michelle Rfrazier Jessen, PhD, Michelle Yclark Stuart, Mihaly S Ligmond, Milos Dokmanovic, PhD, Min Shanmabel Liu, Monica Commerford, PhD, Monika Borkowska, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Natalia Pripuzova, PhD, Navneet Kaur, Nayan J Patel, Nicholas A Violand, Nicholas L Hunt, Nicholas Obiri, PhD, Nicole Yuen, Niketa Patel, Noreen Muñiz, Omotunde O Osunsanmi, Patrice S Hall, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Paul A Bonneau, Paul M Kawamoto, Paula A Trost, Penny H Mccarver, Peter E Baker, Peter Kessler, PhD, Prabhu P Raju, Qing Joanna Zhou, PhD, Quynh H Strandberg, Rachael A Moliver, Rafael Nevarez Nieves, Randall J Plunkett, Raymond T Oji, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Reyes Candau Chacon, PhD, Richard Ledwidge (nmi), PhD, Richard W Berning, Riley C Myers, PhD, Robert D Tollefsen, Robert J Martin, Robert M Barbosa, Robles, Rose Ashley, Rumany C Penn, PharmD, Russell J Glapion, Ruth Moore, PhD, Saied A Asbagh, Sajin Bae, Saleem A Akhtar, Sam Pepe, Samina S Khan, Sandra S Saniga, Sangeeta M Khurana, PhD, Sara H Gabel, Satheesh Thomas, Scott N Lim, Serge L Beaucage, Sergio Chavez (NMI), Shafiq S Ahadi, Sharon K Thoma, PharmD, Sheilyn H Huang, Shelley H Beausoleil, Sheri S Oliver, Sherri J Jackson, Sidney B Priesmeyer, Stefanie R Cook, Stephanie A Slater, MS, Stephen D Brown, Stephen J Koniers, Stephen T Hansen, Steve P Yost, Steven A Gonzales, Steven D Kehoe, Steven J Branch, Stuart W Russell, Susan P Bruederle, Terri L Dodds, Terry A Hook, DPh, Thea C Grome, Theresa Kirkham (NMI), Theressa B Smith, Thomas J Arista, Thomas N Adjabeng, Thomas R Withers, Thomas W Gordon, Thuy T Nguyen, LCDR, Tiffani D Wilson, Timothy C Grome, Timothy T Kapsala, Tomanik'e C Banks, Tracy Denison, PhD, Travis S Bradley, Truong Xuan Nguyen (Andy), Uduak M Inokon, Uttaniti Limchumroon (Tom), Vaishali J Patel, Vibhakar J Shah, PhD, Victoria Taylor, Vlada Matusovsky, Walden H Lee, Wayne L Jefferson, William J Weis, William V Millar, Xiaokuang Lai, PhD, Yasamin Ameri, Yi Wang, PhD, Ying Xin Fan, PhD, Yiyue Zhang (nmi), PhD, Yong Hu, Yumi J Hiramine, Yvesna C Blaise, Yvonne C Mcknight, Zachary A Bogorad, Zachary L Miller

Lance Mde Souza, MBA's Documents

Publish Date Document Type Title
January, 2011 FDA 483 Mylan Specialty, L.P. - Form 483, 2011-01-14
February, 2005 EIR ASEGUA THERAPEUTICS LLC - EIR, 2005-02-17
May, 2013 FDA 483 Grifols Diagnostic Solutions Inc. - Form 483, 2013-05-10
March, 2003 FDA 483 SRI International - Form 483, 2003-03-12
July, 2011 EIR Actelion Pharmaceuticals U.S., Inc. - EIR, 2011-07-21
April, 2006 FDA 483 RPK Pharmaceuticals, Inc. - Form 483, 2006-04-07
May, 2015 FDA 483 Hamamatsu/Queen’s PET Imaging Center, LLC - Form 483, 2015-05-14
March, 2009 FDA 483 BioMarin Pharmaceutical Inc. - Form 483, 2009-03-20
August, 2009 FDA 483 Impax Laboratories, Inc. - Form 483, 2009-08-07
September, 2013 FDA 483 Genentech, Inc. - Form 483, 2013-09-06
June, 2011 FDA 483 Genentech, Inc. - Form 483, 2011-06-23
September, 2007 FDA 483 Genentech, Inc. - Form 483, 2007-09-21
July, 2014 FDA 483 Impax Laboratories, LLC. - Form 483, 2014-07-31
November, 2013 FDA 483 Questcor Pharmaceuticals Inc. (Subsidiary of Mallinckrodt) - Form 483, 2013-11-12
February, 2009 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2009-02-05
December, 2012 FDA 483 Ranbaxy Clinical Pharmacology Unit - Form 483, 2012-12-21
August, 2012 EIR Genentech, Inc. - EIR, 2012-08-29
January, 2015 FDA 483 AnazaoHealth Corporation - Form 483, 2015-01-30
October, 2003 EIR California Primate Research - EIR, 2003-10-31
November, 2013 EIR Questcor Pharmaceuticals Inc. (Subsidiary of Mallinckrodt) - EIR, 2013-11-12
February, 2014 FDA 483 BioMarin Pharmaceutical Inc. - Form 483, 2014-02-18
July, 2018 FDA 483 Response McKesson Corporation Headquarters - Form 483R, 2018-07-25
September, 2012 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2012-09-27
June, 2010 EIR ASEGUA THERAPEUTICS LLC - EIR, 2010-06-14
March, 2014 FDA 483 Haupt Pharma Wolfratshausen GmbH - Form 483, 2014-03-18
August, 2006 EIR Roche Bioscience - EIR, 2006-08-23
December, 2009 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2009-12-04
September, 2003 FDA 483 Response Elan Pharmaceuticals, Inc. - Form 483R, 2003-10-17
September, 2003 EIR Elan Pharmaceuticals, Inc. - EIR, 2003-09-22
August, 2013 FDA 483 AMPAC Fine Chemicals LLC - Form 483, 2013-08-16
July, 2003 EIR Instiutional Animal Care and Use Committee at UCSF - EIR, 2003-07-22
February, 2009 FDA 483 Bayer Healthcare Pharmaceuticals, Inc - Form 483, 2009-02-05
September, 2003 FDA 483 Elan Pharmaceuticals, Inc. - Form 483, 2003-09-22
January, 2013 EIR Bausch Health Americas, Inc. - EIR, 2013-01-23
March, 2014 EIR Haupt Pharma Wolfratshausen GmbH - EIR, 2014-03-18
November, 2013 FDA 483 Response Questcor Pharmaceuticals Inc. (Subsidiary of Mallinckrodt) - Form 483R, 2013-11-21
August, 2012 FDA 483 Genentech, Inc. - Form 483, 2012-08-29
March, 2003 EIR SRI International - EIR, 2003-03-12
December, 2011 FDA 483 Alexza Pharmaceuticals, Inc. - Form 483, 2011-12-12
September, 2003 EIR Genentech, Inc. - EIR, 2003-09-26
May, 2013 EIR Grifols Diagnostic Solutions Inc. - EIR, 2013-05-10
February, 2009 EIR Bayer Healthcare Pharmaceuticals, Inc - EIR, 2009-02-05
August, 2010 EIR Genentech, Inc. - EIR, 2010-08-12
December, 2004 FDA 483 Serologicals Inc. - Form 483, 2004-12-06
July, 2018 FDA 483 McKesson Corporation Headquarters - Form 483, 2018-07-03
June, 2013 EIR Teva Pharmaceutical Works Private Limited Company - EIR, 2013-06-13
May, 2004 EIR Central Admixture Pharmacy Services Inc - EIR, 2004-05-11
September, 2007 EIR Genentech, Inc. - EIR, 2007-09-21
February, 2009 FDA 483 Response Bayer Healthcare Pharmaceuticals, Inc - Form 483R, 2009-02-27
July, 2011 FDA 483 Actelion Pharmaceuticals U.S., Inc. - Form 483, 2011-07-21
March, 2012 FDA 483 Genentech, Inc. - Form 483, 2012-03-28

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