FDA Investigator Lucas B Leake

Lucas B Leake has inspections in 23 countries as of 22 Sep 2023. Lucas B Leake has collaborated with a combinined 7149 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
159
Last Inspection Date:
22 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Australia, Japan, Spain, United States of America, Taiwan, China, Korea (Republic of), Norway, Germany, France, India, Mexico, Denmark, Belgium, Poland, Czechia, United Kingdom of Great Britain and Northern Ireland, North Macedonia, Ireland, Romania, Italy, Israel
Co-Investigator(s):
Adaris Mas Rivera, Ademola O Daramola, Adetutu M Gidado, Adrian Rodriguez, Alan P Kurtzberg, Alex T Goodman, Alexander M Kay, Ana P Pineda Zavaleta, Anastasia M Shields, Andrea A Branche, Angela E Glenn, Anitha P Govada, Anthony A Charity, Anthony J Ladner, Antonetta M Colacchio, Ariel Cruz Figueroa, Arsen Karapetyan, Ashar P Parikh, Atul J Agrawal, Azza Talaat, Barbara A Gullick, Barbara J Rincon, Bingchen Du, Binh T Nguyen, Blondell W Johnson, Bonita S Chester, Bowman, Brian P Hendrickson, Brittany D Terhar, Bruce H Mccullough, Bruce R Burrell, Bruce W Benware, Burnell M Henry, Carl Lee, Carla A Norris, Carla J Lundi, Carla M Fernandez Borges, Carolina D Vasquez, Carr Sharpe, Carrie E Jolly, Caryn M Everly, Caryn M Mcnab, Cathy Condon, Cathy L Condon, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Charanjeet Jassal, Charisse K Green, Charles B Steinmiller, Charles D Brown, Charles L Larson, Cheryl D Mccall, Christine L Williams, Christopher D Leach, Christopher M Jenner, Christopher N Tran, Christopher T Peters, Ciara J Bajulai Austin, Concepcion Cruz, Jr, Courtney N Long, Craig T Rybus, Cynthia J Lee, MS, Cynthia Jim, CSO, Dale A Nyberg, Daniel J Lahar, Danielle Lyke, Darla J Christopher, Darrin E Davis, David C Thomas, David G Whitman, David J Gomes, David M Beltran, Deborah A Greco, Debra D Devlieger, Debra J Bennett, Deniza Karacic, Dennis Cantellops Paite, Derek S Smith, PhD, Diana L Ayala, Diana M Rand, Diane Goll, Dinesh Kumar, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Donald L Lech, Donna Ltartaglino Besone, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Gang Wang, PhD, Dr. Robert C Horan, MD, Edward D Edmiston, Edward J Janik, Edward P Potter, Edwin Ramos, Elizabeth P Mayer, Elkins, Emest F Bizjak, Emilio O Escobar, Eric M Mueller, PharmD, Eric R Holm, Erica R Havely, Erica R Woody, Erik W Koester, Erika V Butler, Ernest Serna, III, Everard A Irish, Francis A Guidry, Garciam, Garrad R Poole, Gary C Pecic, Gene R Gunn, George J Flynn, Gerald B Seaborn, Jr, Geraldine D Sanders, Geraldine Sanders, Gery M Duparc, Grant, Greg K Keshishyan, Gulshan R Anand, H Ljamilla Selby, Hagstrom, Hala L Selby, Harperd, Harry A Wilson, Hasan A Irier, PhD, Helen B Ricalde, Heriberto Negron Rivera, Holly Brevig, Holly J Smith, Hung V Le, Hung Van Le, Iris C Macinnes, Ivis L Negron, Ivis Lnegron Torres, Jacob W Reynolds, James A Barreto, James C Maclaughlin, James I Giefer, James L Dunnie, Jr, James P Mcreavey, James P Stallings, Jamie M Bumpas, Janet L Bowen, Janet Pulver, Jason K Morgan, Jawaid Hamid, Jennifer A Jones, Jennifer A Robinson, Jennifer Lalama, Jennifer M Heitz, Jennifer M Pouget, Jennifer Owens Dowdy, Jennifer R Mathern, Jessica L Pressley, Jill J Tillman, Joanne E King, Jodi M Gatica, Joel D Martinez, Johann M Fitch, John A Daubenspeck, John A Gonzalez, John A Iwen, Jonaida Estevez Martinez, Jorge L Gonzalez, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose Martinez, Jr, Jose R Hernandez, Joseph M Allen, Joy L Ramsey, Juan D Lopez, Juanita P Versace, Julia Ventura, Julian C Hanson, Junho Pak, Justin A Boyd, Justine Tomasso, Ka L Wong, Kaitlyn T Dang, Karen C Daugherty, Karen L Kosar, Karen M Labounty, Karen Takahashi, Katherine Szestypalow, Kathleen Chmura Shaffer, Keith C Littrell, Kejun Cheng, Kelley, Kellia N Hicks, Kelvin Cheung, Kelvin X Sanders, Kenneth S Bochmen, Kenneth S Boehnen, Kevin D Kallander, Kevin P Regan, Kham Phommachanh, Khumo A Phake, Kibily D Dembele, Kim Lthomas Cruse, Kip J Hanks, Kirtida Patel, Kristen E Szenderski, Kristy A Zielny, La Tasha M Gunter, Lam, Larry K Austin, Latorie S Jones, Laura A Munsterman, Laura L Van Wagenen, Laurie A Haxel, Laurie B Frazier, Laurimer Kuilan Torres, LCDR Wilfred A Darang, Liming Zhang, Linda F Murphy, Linda S Mattingly, Linda Thai, Lindsey S Fleischman, Lisa L Flores, Lisa M Bellows, Lisa R Jennings, Lloyd D Payne, Lori G Cantin, Lorie S Hannappel, Lourdes Valentin Aponte, LT Richard A Lyght, Luis A Dasta, Luis M Burgos Medero, Maira P Brading, Marcellinus D Dordunoo, Marcus F Yambot, Margaret M Annes, Margaret Torres Vazquez, Margo Cl Jones, Marianela Aponte Cruz, Marie F Morin, Mark C Saale, Mark R Mcclain, Marlo Ianm Alintanahin, Martinez, Martrice A Packer, Mary T Carden, Massoud Motamed, Matthew B Casale, Matthew J Johnson, Matthew R Maddox, Maxyne T Lam, Meaghan M Rabideau, Meisha R Sampson, Meisha Waters, Michael A Charles, Michael D Garcia, Michael P Sheehan, Michael R Goga, Michele L Obert, Michele Perry Williams, Michelle A Krayer, Michelle A Marsh, Michelle J Hines, Miguel A Martinez, Monique Rac Lester, Mra Davism, Mra Greenc, Mra M Barbosar, Mra Munizn, Muralidhara B Gavini, PhD, Myers, Nadeem I Chaudhry, Nancy A Saxenian Emmons, Nancy G Schmidt, Nebil A Oumer, Nianna C Burns, Nianna M Capalia, Nicholas A Violand, Nicholas Fragedakis, Nicholas L Hunt, Nicole E Knowlton, Nimmy Mathews, Noreen Muniz, Oluwasefunm Agbanigo, Oluwaseyi Ojinni, Omotunde O Osunsanmi, Osama M Hamoud, Parul M Patel, Patrice S Hall, Patricia P Wrona, Patrick C Klotzbuecher, Patrick D Stone, MS, Patrick L Wisor, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul R Whitby, Phal K Chhun, Philip F Istafanos, DMV, MS, Phillip J Sample, Pratik S Upadhyay, DDC, Rachel C Harrington, Rafael Nevarez Nieves, Rajiv R Srivastava, Ramon A Hernandez, Raquel Gonzalez Rivera, Rebecca C O Bryan, Rebecca E Dombrowski, Regina T Brown, Rene R Ramirez, Rian L Pope, Richard E Needham, Richard T Jensen, Rita K Kabaso, Robert C Coleman, Robert C Steyert, Robert M Tillman, Robert T Lorenz, Rochelle A Rolnik, Rochelle K Kimmel, Rocio Guzman Velazquez, Rodney L Tinzie, Rose M Ashley, Rowena Trevino Solis, Roy Baby, Roy R Rinc, Russell J Glapion, Sakineh Walther, Saleem A Akhtar, Samantha E Rafferty, Samantha J Bradley, Samina S Khan, Sandra A Hughes, Sandra I Huff, Sandra K Masters, Sandra L Shire, DMD, MPA, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sara Jdent Acosta, Saundrea A Munroe, Scott B Laufenberg, Scott T Ballard, Sean P Desbrow, Selina M Mata, Sha'tina R Alridge, Sharon K Thoma, PharmD, Shawn E Larson, Sheila Alaghemand, Shelby N Marler, Simone E Pitts, Sina Shojaee, Sonia R Peterson, Staci G Mcallister, State Agency, Stephany J Wesley, Stephen D Brown, Stephen L Beekman, Steven A Gonzales, Steven E Porter, Jr, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susanna E Ford, Analyst, Susant Hadman, Tammy Vasquez Hancock, Tanya E Malais, Ted L Anderson, Teresa I Navas, Thanh M Andrews, Thao T Kwan, Thao X Tran, Thomas J Arista, Thomas Martinez, Thomas W Gordon, Thuy T Nguyen, LCDR, Tiffani D Wilson, Timothy T Kapsala, Torrance J Slayton, Tricia S Martinez, Truong Xuan Nguyen (Andy), Trushani T Desai, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vanessa R Muller, Veronica Fuentes, MS, Vidya B Pai, Vincent Thomas, Virgilio F Pacio, CSO, Vlada Matusovsky, Walden H Lee, Wayne D Mcgrath, Wayne L Jefferson, William A Warnick, William J Leonard, William S Vitale, Xiaokuang Lai, PhD, Yasamin Ameri, Young M Choi, PhD, Youngjd, Yumi J Hiramine, Yvins Dezan, Zachary A Bogorad

Lucas B Leake's Documents

Publish Date Document Type Title
February, 2014 FDA 483 Response Mission Pharmacal Company - Form 483R, 2014-02-27
August, 2012 FDA 483 ICU MEDICAL INC. - Form 483, 2012-08-24
September, 2013 FDA 483 Specialty Compounding, LLC - Form 483, 2013-09-13
January, 2016 FDA 483 Rolabo Outsourcing S.L. - Form 483, 2016-01-21
October, 2016 FDA 483 OHTA'S ISAN CO.,LTD. - Form 483, 2016-10-28
March, 2018 FDA 483 Vamsi Labs Limited - Form 483, 2018-03-16
June, 2013 EIR Sovereign Pharmaceuticals, LLC - EIR, 2013-06-21
March, 2018 FDA 483 Glenmark Life Sciences Limited - Form 483, 2018-03-22
March, 2013 FDA 483 Home Intensive Care Pharmacy, Inc. - Form 483, 2013-03-01
July, 2017 EIR Industrias Químicas Falcón de México, S.A. de C.V. (DR. REDDY'S MEXICO) - EIR, 2017-07-20
December, 2014 FDA 483 American Specialty Pharmacy - Form 483, 2014-12-19
June, 2013 FDA 483 Response Sovereign Pharmaceuticals, LLC - Form 483R, 2015-09-10
March, 2014 FDA 483 API Resources LLC - Form 483, 2014-03-07
June, 2013 FDA 483 Sovereign Pharmaceuticals, LLC - Form 483, 2013-06-21
December, 2008 EIR River Ranch Fresh Foods, LLC - EIR, 2008-12-11
February, 2014 EIR Mission Pharmacal Company - EIR, 2014-02-07
March, 2013 FDA 483 Specialty Compounding, LLC - Form 483, 2013-03-22
July, 2014 FDA 483 I.V. Specialty, Ltd - Form 483, 2014-07-22
January, 2016 FDA 483 Farmhispania S.A. - Form 483, 2016-01-15
June, 2012 EIR McKesson Specialty Health Arizona - EIR, 2012-06-21
April, 2012 EIR Eisai Company Ltd. - EIR, 2012-04-26
March, 2013 FDA 483 American Red Cross National Headquarters - Form 483, 2013-03-01
March, 2013 FDA 483 Oakdell Pharmacy, Inc - Form 483, 2013-03-01
November, 2017 FDA 483 Savior Lifetec Corporation Tainan Branch Injection Plant - Form 483, 2017-11-17
September, 2017 FDA 483 Baxter Laboratories Pty. Ltd. - Form 483, 2017-09-22
January, 2016 EIR Deretil Sa - EIR, 2016-01-08
October, 2010 FDA 483 Precision Science, Inc. - Form 483, 2010-10-06
November, 2015 FDA 483 VUAB Pharma A.S. - Form 483, 2015-11-05
February, 2014 FDA 483 Mission Pharmacal Company - Form 483, 2014-02-07
December, 2008 EIR Taylor Fresh Foods, Inc. - EIR, 2008-12-10
February, 2011 FDA 483 Brenntag Pacific, Inc. - Form 483, 2011-02-07
July, 2015 FDA 483 Hetero Labs Limited - Form 483, 2015-07-31
July, 2015 EIR Hetero Labs Limited - EIR, 2023-10-06

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