FDA Investigator James W Leonette

James W Leonette has inspections in 18 countries as of 03 Nov 2023. James W Leonette has collaborated with a combinined 4228 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
221
Last Inspection Date:
03 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Lithuania, Canada, United Kingdom of Great Britain and Northern Ireland, Germany, Denmark, Sweden, Italy, France, Switzerland, Norway, Taiwan, China, Ireland, Japan, Czechia, Thailand
Co-Investigator(s):
A Williams, Adaliz Santaliz Cruz, Adams, Adriana N Jimenez Lopez, Alan C Gion, Alexandria L Capuano, Amanda B Athey, Amber G Chung, Amy A Johnson, Amy C Amaro, Amy M Cramer, Amy S Graf, Andrea Lwilliams Jones, Annet R Rajan, Anthony F Lorenzo, Anthony W Hite, Anthony W Lee, Ashley A Mutawakkil, Ashley M Whitehurst, Barbara A Burke, Barbara A Gullick, Barbara A Rusin, Brandon L Mariner, Brian M Palermo, Brian P Putz, Brooke K Higgins, Brooke K Secman, Burnell M Henry, Candice C Mandera, Carole L Jones, Carolyn E Barney, Carrie L Doupnik, Cassandra L Winters, Catherine J Laufmann, Cecil D Mitchell, Chaltu N Wakijra, Charles D Boison, Charles L Larson, Charles M Kerns, BLT DO, Chiang Syin, PhD, Christine I Shaw, Christine M Parmentier, Collins, Cynthia A Harris, MD, RN, Cynthia L Rakestraw, Daniel J Lahar, Denise R Beuttenmuller, Dennis L Doupnik, Derek C Price, Derek S Smith, PhD, Diane T Bargo, Diane T O'bien, Diane T O'brien, Dianne H Milazzo, Dipesh K Shah, Dirk L Lincoln, Douglas A Campbell, Edward P Potter, Elizabeth B Griffin, Elvis D Morton, Emest F Bizjak, Emmanuel A Dimaano, Jr, Ephrem Hunde, PhD, Eric R Vandegeer, Erin L Mcfiren, Esaw, Frederic W French, III, Gale L Glinecki, Gerald B Seaborn, Jr, Gerald D Bromley, Jr, Gerald Mierle, Gladys B Casper, Hamilton, Harperd, Heath R Harley, Helen B Ricalde, Holly S Simms, Hongna Wang, Jacob M Dyer, Jacqueline Johnson, James A Beaulieu, James M Odonnell, James M Simpson, James T Mccoy, James W Plucinski, Jamie D Richardson, Jamie D Swann, Janet A Rajan, Janet Pulver, Janete F Guardia, Javonica F Penn, Jeanne D Shaffer, Jennifer L Sheehan, Jesse P Hardin, Jessica Hankins, PhD, Joanne V Macon, Jocelyn E Massey, Jocelyn E Sparks, Joey C West, John A Sciacchitano, John D White, John Dan, John M Gusto, Johnson, Jonathan W Chapman, Joseph A Morkunas, Joseph W Matthews, Joshua J Silvestri, Joyce A Rockwell, Jude C Dikes, Justin A Hefferman, Karen A Spencer, Katelyn Astaub Zamperini, Katherine E Jacobitz, Kathleen M Jordan, Kathleen S Tormey, Keith M Reilly, Kelly L Anderson, Kenneth Nieves, Krista N Flores, Kwong P Lee, Lakisha M Williams, Latoya Oliver Powell, Latoya S Oliver Powell, Laureen F Kononen, Laureen M Geniusz, Laurie B Frazier, Laurissa Flowers, Laurissa S Flowers, Lawrence J Stringer, LCDR Anastasia Mpiliafas Brown, LCDR Cornelius Brown, III, LCDR Debra Emerson, LCDR Wilfred A Darang, Leena Thomas, Leonard H Lavi, Liatte Kreuger, PharmD, Linda J Eason, Lindsey L Kirsh, Lisa A Warner, Loretta Nemchik, Lori S Lawless, Lydia S Chan, Malgorzata G Norton, Marc S Neubauer, Marcellinus D Dordunoo, Marcus A Ray, Margaret Torres Vazquez, Maribeth G Niesen, Marion Michaelis, Marion W Nadeau, Mark E Parmon, Mary E Storch, Meade, Melissa J Garcia, Merideth K Rose, Michael J Vardon, Michael L Zimmerman, Mildred L Mccray, Minh D Phan, Nancy L Meade, Nancy L Neiger, Nash, Nebil A Oumer, Nicholas A Violand, Nicholas P Schaub, Nicole K Trudel, Nicole S Williams, Nina D Patel, Oumou Barry, Patricia A Morrow, Patrick C Klotzbuecher, Paula J Bretz, Perry H Gambrell, Philip W Beck, Prabhu P Raju, Pratik S Upadhyay, DDC, Pushpa S Jayasekara, Qiang Gui, Qin Xu, Quyen T Tran, Rachel C Harrington, Rafael Padilla, Regina Gibson Melton, Richard Jay Tucker, RS, Richard L Rutherford, Robert G Ruff, Robert J Doyle, Robert J Martin, Ronald T Nowalk, Rosanna M Goodrich, Roseline N Boateng, Roy Baby, Sarah A Hassas, Scott R Nichols, PhD, Sean R Moynihan, MPH, Selene T Torres, Sena G Dissmeyer, Seth A Mailhot, Shafiq S Ahadi, Shannon A Gregory, Shaquenta Y Perkins, Shusheen A Alexander, Sierra M Shockley, Simone E Pitts, Slatten, Stacey A Priest, State Agency, Stephanie L Shapley, Stephen D Eich, Steven J Thurber, Steven P Donald, Suzanne M Healy, Suzanne M Muchene, Tajah L Blackburn, Tamara N Champion, Tania E Garcia, Tania E Vizcaino, Thai T Duong, Thao X Ta, Thomas N Adjabeng, Thomas R Withers, Tiki J Dixon, Timothy M Albright, Tony T Yang, Toyin B Oladimeji, Travis R Hunt, Valeria A Moore, Vesa Vuniqi, Walter Fava, Walter L Fava, Wanda Y Honeyblue, Wayne L Jefferson, William A Warnick, William D Bassett, Jr, William D Murray, William D Tingley, William H Linkroum, Xiandong Meng, Yan Qin, Yehualashet A Gessesse, Zhongren Wu

James W Leonette's Documents

Publish Date Document Type Title
December, 2004 FDA 483 United Dairy, Incorporated - Form 483, 2004-12-14
July, 2011 FDA 483 Response Shanghai Kindly Enterprise Development Group Co., Ltd. - Form 483R, 2011-10-20
October, 2002 FDA 483 Triaid, Inc. - Form 483, 2002-10-18
March, 2012 FDA 483 Gooten Innolife Corp - Form 483, 2012-03-08
May, 2012 FDA 483 Delta Med SpA - Form 483, 2012-05-03
November, 2011 FDA 483 Sofradim Production - Form 483, 2011-11-07
June, 2012 FDA 483 Nissei Precision Instruments (Suzhou) Co., LTD - Form 483, 2012-06-28
January, 2004 FDA 483 Farmstead Feed and Seed - Form 483, 2004-01-08
August, 2004 FDA 483 Microbiological Consultants, Inc. - Form 483, 2004-08-11
March, 2005 EIR Tetracore, Inc. - EIR, 2005-03-09
August, 2002 EIR Synergy Health North America - EIR, 2002-08-16
March, 2005 FDA 483 Tetracore, Inc. - Form 483, 2005-03-09
June, 2012 EIR Nissei Precision Instruments (Suzhou) Co., LTD - EIR, 2012-06-28
June, 2012 EIR Kawasumi Laboraratories (Thailand) Co. Ltd. - EIR, 2012-06-21
December, 2004 FDA 483 Green Acres Regional Center, Inc. DBA LeSage Natural Water - Form 483, 2004-12-16
December, 2004 FDA 483 The Water Store - Form 483, 2004-12-29
July, 2011 EIR Shanghai Kindly Enterprise Development Group Co., Ltd. - EIR, 2011-07-19
September, 2010 FDA 483 Response SriSai Biopharmaceutical Solutions, LLC - Form 483R, 2010-10-06
April, 2011 FDA 483 Eastern Cranial Affiliates, LLC - Form 483, 2011-04-13
September, 2010 FDA 483 SriSai Biopharmaceutical Solutions, LLC - Form 483, 2010-09-24
May, 2002 EIR Airgas Usa, LLC - EIR, 2002-05-16
July, 2003 FDA 483 Aplicare Incorporated - Form 483, 2003-07-22
September, 2011 FDA 483 Stratec Medizintechnik Gmbh - Form 483, 2011-09-07
April, 2002 FDA 483 Penniman & Browne, Inc. - Form 483, 2002-04-08
November, 2004 FDA 483 Aplicare Incorporated - Form 483, 2004-11-17
September, 2010 EIR SriSai Biopharmaceutical Solutions, LLC - EIR, 2010-09-24
November, 2011 FDA 483 Lake Region Medical, Ltd. - Form 483, 2011-11-10
May, 2012 FDA 483 Pan Medical Ltd. - Form 483, 2012-05-10
March, 2003 FDA 483 Nicholas Pharmacy - Form 483, 2003-03-21
November, 2002 FDA 483 Neurotron. Inc. - Form 483, 2002-11-14
March, 2002 FDA 483 Response Cangene BioPharma, LLC - Form 483R, 2002-05-06
May, 2002 FDA 483 Airgas Usa, LLC - Form 483, 2002-05-16
July, 2012 FDA 483 Xiantao Rayxin Medical Products Co. Ltd. - Form 483, 2012-07-04
July, 2011 FDA 483 Shanghai Kindly Enterprise Development Group Co., Ltd. - Form 483, 2011-08-30
October, 2011 FDA 483 HemoCue AB - Form 483, 2011-10-26
March, 2002 EIR Cangene BioPharma, LLC - EIR, 2002-03-27
October, 2002 FDA 483 Nae-Tech Company - Form 483, 2002-10-10
April, 2004 FDA 483 FMC Corporation - Form 483, 2004-04-06
June, 2010 FDA 483 Eastern Cranial Affiliates, LLC - Form 483, 2010-06-18
January, 2004 EIR Farmstead Feed and Seed - EIR, 2004-01-12
February, 2005 FDA 483 Microbiological Consultants, Inc. - Form 483, 2005-02-02
October, 2011 FDA 483 Cortex Technology ApS - Form 483, 2011-10-31
March, 2002 FDA 483 Cangene BioPharma, LLC - Form 483, 2002-03-27

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