FDA Investigator Gerard Pde Leon

Gerard Pde Leon has inspections in 4 countries as of 25 Aug 2023. Gerard Pde Leon has collaborated with a combinined 4168 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
110
Last Inspection Date:
25 Aug 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Germany, Japan, Sweden
Co-Investigator(s):
A Williams, Aaron J Poloni, Abby M Miller, Alan D Grupe, Alexander M Kay, Alicia A Borg Borm, Amber M Howell, Anita Narula, PhD, Annette L Diggs, Ashar P Parikh, Astrida B Mattson, Ava M Bowman, Avery J Dennis, Barbara J Rincon, Barbara Janine Breithaupt, Bradley Dworak, PhD, Brenda K Alford, Brenda L Reihing, Brenda W Uratani, PhD, Brian E Thompson, Brian W Man, Bruce R Burrell, Bryan L Mcguckin, Camille Bennett Hoffman, Carl A Anderson, Caryn M Mcnab, Catherine J Laufmann, Ce'nedra M Martin, Celia L Hutchinstein, Christian D Lynch (CDL), Christine A Harman, PhD, Christopher R Czajka, Christopher S Genther, Clinton R Vanblaricom, Connie P Rezendes, Connie P Rezenes, Crystal A Harlan, Cynthia J Lee, MS, Cynthia L Gorveatt, Damon A Growl, Dandan Wang, PhD, Daniel A Congdon, David A Quale, David D Anderson, PhD, David J Gomes, David L Hunsaker, Dawn E Barkans, Deborah A Nebenzahl, Debra D Devlieger, Dennis R Hudson, Devon M Shoop, Dirk L Lincoln, Dolores E Price, Don A Brunssen, Don H Bark, PhD, Douglas J Snyder, Edwin Melendez, Eileen A Liu, Elizabeth S Howell, Eric C Milstead, Erica D Butler, Erika V Butler, Farhana Khan, Fonda Olsen, Gary C Pecic, Gavin T Cua, Gavin W Pierce, Gloria J Baca, MS, Gordon T Wales, Graham N Giesen, Guerlain Ulysse, Harmon M Blanch, Heika R Bounds, Heika R Tait, Hugh A Grimoldby, Hugh Grimoldby, Ian J Thomson, Jacqueline Mdiaz Albertini, James C Henry, James C Maclaughlin, James E Trabert, James I Vik, James R Fleckenstein, James S Stuart, BS, Jane M Kreis, Janelle K Martin, Jean Brewer, Jean C Colon Lopez, Jean R Mccurry, Jeanmaire Hryshko, Jeanne M Weishaar, Jeannie Pradyanata, Jeffrey J Leclair, Jeffrey N Gerdes, Jeffrey P Raimondi, Jen Sui, Jennifer L Bridgewater, Jennifer Lalama, Jeremy W Rotton, Jessica B Clark, Jessica L Friedt, Jessica L Pressley, Jinkee Mvila Binayug, Joey V Quitania, John W Banks, Joie A Riehle, Jonathan T Little, Julia E Chervoni, Julian C Hanson, Julie A Stocklin, Kari M Johansen, Katherine L Arnold, Kathryn A Krentz, Keegan B Mixon, Kelsey M Bishop, Kenneth O Gee, PhD, Kevin T Gerrity, Kham Phommachanh, Kimberly J Proctor Jones, Kristin M Abaonza, Kristina M Phelps, Lance M De Souza, MBA, Lance W Bohm, Laurel A Beer, Lauren E Swantko, Lawrence Y Lee, PhD, LCDR Debra Emerson, Leon R Marquart, Lesley A Swanson, Lester O Boian, Linda F Murphy, Lisa A Bowden, Lisa K Capron, Lisa T Michel, Lon A Cummings, Lori J Silverstein, Luis M Burgos Medero, Lynda L Perry, PhD, Marcellinus D Dordunoo, Margaret M Annes, Margo C Jones, Margo Cl Jones, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Mariza M Jafary, Mark E Imsland, Mark E Moen, Mark S Crippen, Mark W Babbitt, Marsha L Mccauley, Maxine H Wong, Meisha R Sampson, Meisha Waters, Michael F Schuette, Michael J Donovan, Michael S Valenzuela, Michelle L Orner, Michelle Y Clark Stuart, Mihaly S Ligmond, Mikel T Wright, Mra Davism, Nancy E Byerly, Nancy E Doyle, Nataniel Phillips Sylvain, PhD, Nayan J Patel, Neil J Traaen, Omotunde O Osunsanmi, Orval D Mcintire, Paul A Bonneau, Paul F Rader, Paul M Kawamoto, Paula A Trost, Paula J Wilkerson, Peter C Chow, Peter T Regan, Prabhu P Raju, Randy L Elsberry, Randy L Self, Rebecca A Sletner, Rebecca Rodriguez, Rebecca T Davis, Richard A Martin, Robert D Tollefsen, Rocco C Black, Ronald E Gill, S Lori Brown, PhD MPH, Saied A Asbagh, Sandra K Wangen, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Savini, Scott A Nabe, Scott W Fox, Seneca D Toms, Shahriar Rahmani, Shannon J Hall, Sharon I Gundersen, Sharon K Thoma, PharmD, Shelagh D Schopen, Sherryl Stoltenow, Shuen G Chai, Stacy A Schneider, State Agency, Stephanie A Slater, MS, Stephen L Manza, Stephen R Souza, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan P Bruederle, Tara A Marshall, Tara M Pianko, Terri L Dodds, Terry L Dodds, Thomas C Mclean, CFS, Thomas J Arista, Tina S Roecklein, Tracy K Li, Tracy M Portelli, Uttaniti Limchumroon (Tom), V Teres Speer, Vanessa Y Gelsey, PhD, Vitaliy N Guyvan, Wendy G Tan, PhD, Wilfred J Omoloh, William A Burkey, Willis L Hicks, Xiaojun Yan, Xiaokuang Lai, PhD, Xiomara Copeland, Young M Yoon, Yumi J Hiramine, Yvonne M Larsen, Zachary L Stamm, Zachary P Wachlarowicz

Gerard Pde Leon's Documents

Publish Date Document Type Title
July, 2015 FDA 483 Response Jubilant HollisterStier LLC - Form 483R, 2015-08-26
August, 2017 FDA 483 Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - Form 483, 2017-08-02
June, 2011 FDA 483 Snokist Growers - Form 483, 2011-06-02
September, 2019 EIR LYOCONTRACT GmbH - EIR, 2019-09-20
September, 2015 FDA 483 Mountain Spirit LLC dba Mountain Spirit Herbal Company - Form 483, 2015-09-30
September, 2016 FDA 483 TAYCA CORPORATION - Form 483, 2016-09-09
August, 2016 FDA 483 University of Washington Inpatient Pharmacy - Form 483, 2016-08-04
August, 2016 FDA 483 Response University of Washington Inpatient Pharmacy - Form 483R, 2016-08-04
July, 2015 FDA 483 HTO Nevada, Inc. (dba Kirkman) - Form 483, 2015-07-15
January, 2011 EIR Queseria Bendita LLC - EIR, 2011-01-26
February, 2020 EIR Haupt Pharma Wolfratshausen GmbH - EIR, 2020-02-14
May, 2016 FDA 483 Ballard Plaza Pharmacy I, Inc. - Form 483, 2016-06-10
June, 2011 FDA 483 Response Snokist Growers - Form 483R, 2011-06-22
February, 2016 FDA 483 Option Care Enterprises, Inc. - Form 483, 2016-02-25
July, 2015 FDA 483 Jubilant HollisterStier LLC - Form 483, 2015-07-31
September, 2019 FDA 483 LYOCONTRACT GmbH - Form 483, 2019-09-20
March, 2017 FDA 483 Response Compound Preferred LLC - Form 483R, 2017-03-22
March, 2017 FDA 483 Compound Preferred LLC - Form 483, 2017-03-01
December, 2016 FDA 483 Response First Pharma Associates LLC dba Riverpoint Pharmacy - Form 483R, 2017-01-11
July, 2015 EIR Jubilant HollisterStier LLC - EIR, 2015-07-31
September, 2014 FDA 483 Heron Botanicals, Inc. - Form 483, 2014-09-17
May, 2014 FDA 483 Scientific Botanicals Company, Inc. - Form 483, 2014-05-19
July, 2015 FDA 483 Kirkman Laboratories, Inc. - Form 483, 2015-07-15
December, 2016 FDA 483 First Pharma Associates LLC dba Riverpoint Pharmacy - Form 483, 2016-12-16

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