FDA Investigator Tracy K Li

Tracy K Li has inspections in 3 countries as of 24 May 2023. Tracy K Li has collaborated with a combinined 4490 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
159
Last Inspection Date:
24 May 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Canada, India
Co-Investigator(s):
Aaron J Poloni, Abby M Miller, Alan P Kurtzberg, Alexander M Kay, Alice A Blair, Alicia A Borg Borm, Alicia K Mckinsey, Allison V Bonnenburg, Amanda L Fyles, Amy R Glynn, Anastasia M Shields, Andrew Le, Anissa M Vargas, Anita Narula, PhD, Ann L Demarco, Arie R Dyk, Ashar P Parikh, Ashleigh P Barkans, Astrida B Mattson, Barbara J Rincon, Barbara Janine Breithaupt, Beau R Lamb, Belinda E Clifton, Binh T Nguyen, Bo Chi, PhD, Bradley Dworak, PhD, Brandi N Mcgrady, Bruce R Burrell, Bryan L Mcguckin, Bryce E Mansfield, Camille Bennett Hoffman, Carl A Anderson, Carl Lee, Carolyn E Barney, Carrie A Hughes, Caryn M Mcnab, Catherine J Laufmann, Celia L Hutchinstein, Celia L Silverstein, Cheryl A Clausen, Chiaochun J Wang, Christian D Lynch (CDL), Christina L Norton, Christine A Harman, PhD, Christopher R Czajka, Christopher S Genther, Christopher T Middendorf, Chyla T Hunter, Clinton R Vanblaricom, Connie P Rezendes, Connie P Rezenes, Courtney R Bolton, Crystal A Harlan, Crystal Monroy, Cynthia J Lee, MS, Dandan Wang, PhD, Daniel J Lahar, Darren S Brown, David J Gomes, Dawn E Barkans, Dawn M Braswell, Debra D Devlieger, Demitria J Xiradakis, Devon M Shoop, Dirk L Lincoln, Dolores E Price, Don H Bark, PhD, Donald B Mckechnie, Donald C Obenhuber, PhD, Edna J Hidalgo, Edwin Melendez, Eileen A Liu, Elizabeth A Sheller, Elizabeth S Howell, Elsa Y Yu, Emal Wahab, Eric C Milstead, Eric L Scott, Erica R Pomeroy, Erika V Butler, Erin D Mccaffery, Erin L Nagel, Farhana Khan, Felix Maldonado, Gary C Pecic, George Lunn, PhD, Gerard Pde Leon, Gina C Collins, Gloria J Baca, MS, Graham N Giesen, Harmon M Blanch, Heika R Bounds, Heika R Tait, Hugh A Grimoldby, Hugh Grimoldby, Hughes, Huiquan Wu, Hung H Do, MS, Ian J Thomson, Ivis Lnegron Torres, Jacqueline Mdiaz Albertini, James A Lane, James C Henry, James D Hildreth, James L Dunnie, Jr, James L Finn, Jane M Kreis, Jason W Cornell, Jean Brewer, Jean C Colon Lopez, Jeanne M Weishaar, Jeff A Gard, Jeffery A Hangartner, Jeffrey J Leclair, Jennifer L Bridgewater, Jennifer S King, Jessica B Clark, Jessica B Zachman, Jinkee Mvila Binayug, Joey V Quitania, John Burr, Jonathan G Matrisciano, Jonathan T Little, Jose R Hernandez, Jude C Dikes, Julia Ventura, Julian C Hanson, Kari M Johansen, Katharine Chan, Katherine Szestypalow, Kathryn A Krentz, Kay, Keegan B Mixon, Kelsey M Bishop, Kenneth O Gee, PhD, Kevin A Gonzalez, Kevin Obrien, Kham Phommachanh, Ko U Min, Kristin M Abaonza, Kristina M Phelps, Kristopher J Stanya, PhD, Larry K Austin, Laura A Grumenfelder, Laurel A Beer, Lawrence Y Lee, PhD, LCDR Debra Emerson, Leon R Marquart, Lesley A Swanson, Linan Ha, PhD, Linda M Cheny, Lisa A Bowden, Lisa K Capron, Lisa Shin, Lisa T Michel, Lori J Jennings, Lorna F Jones, LT Mark A Chen, MPH, Lynda L Perry, PhD, Mai Hang, Margo Cl Jones, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark E Imsland, Mark I Nakano, Mark W Babbitt, Matthew M Vernon, Maxine H Wong, Mei Chiung J Huang, Michael F Schuette, Michael S Hudson, Michele Gottshall, Mihaly S Ligmond, Mikel T Wright, Muralidhara B Gavini, PhD, Nancy A Saxenian Emmons, Nancy E Byerly, Nancy E Doyle, Nataniel Phillips Sylvain, PhD, Nayan J Patel, Neil J Traaen, Nicholas L Hunt, Omotunde O Osunsanmi, Parul M Patel, Patricia A Cochran, Patricia H Dlugosz, Patrick R Brown, Paul F Rader, Paul Rader, Paula A Trost, Peter Kessler, PhD, Peter T Regan, Philippe A Cornet, Prabhu P Raju, Rachelle M Deskins, Rafeeq A Habeeb, Randy L Self, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Robert D Tollefsen, Rocco C Black, Roger F Zabinski, Ronald E Gill, Rowena S Nguyen, S Lori Brown, PhD MPH, Sandra K Wangen, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santos E Camara, Sara H Gabel, Savini, Scott A Nabe, Scott W Fox, Seema S Singh, Shahriar Rahmani, Shannon J Hall, Sharon L Shane, Shelagh D Schopen, Sherri N Rohlf, MD, Sonia R Peterson, Sridhar Thumma, Stanley B Eugene, BS, BME, State Agency, Stephanie A Slater, MS, Stephen D Brown, Sunitha K Rajaram, PhD, Sunny R Muir, Susan F Laska, MS, Susan O Oladeji, Tara M Pianko, Tenzin Jangchup, Terri L Dodds, Terry L Dodds, Thomas C Mclean, CFS, Thomas J Arista, Timothy D Evans, Timothy S Williamson, Tina S Roecklein, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vioela J Caze, Vitaliy N Guyvan, William A Burkey, William C Hughes, William J Foust, Xing Wang, PhD, Xiomara Copeland, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zachary P Wachlarowicz

Tracy K Li's Documents

Publish Date Document Type Title
May, 2018 EIR Unique Chemicals - EIR, 2018-05-11
November, 2017 FDA 483 Trone Health Services, Inc. - Form 483, 2017-11-21
May, 2018 FDA 483 Unique Chemicals - Form 483, 2018-05-11
April, 2015 EIR Paragon BioTeck, Inc. - EIR, 2015-04-03
August, 2018 FDA 483 Response Pharm D Solutions, LLC - Form 483R, 2018-09-13
August, 2015 FDA 483 Galena Biopharma, Inc. - Form 483, 2015-08-25
September, 2016 FDA 483 Montana Compounding Pharmacy PC - Form 483, 2016-09-20
July, 2017 FDA 483 JD & SN Inc. - Form 483, 2017-07-12
June, 2016 FDA 483 Bend Research Inc. - Form 483, 2016-06-03
June, 2016 FDA 483 Bend Research Inc. - Form 483, 2016-06-03
September, 2018 FDA 483 Maag Prescription Center LLC - Form 483, 2018-09-28
June, 2016 FDA 483 Bend Research Inc. - Form 483, 2016-06-03
April, 2017 FDA 483 Kirkman Laboratories, Inc. - Form 483, 2017-04-14
October, 2015 FDA 483 Cheta Nand, M.D. - Form 483, 2015-11-19
January, 2019 FDA 483 Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy - Form 483, 2019-01-28
August, 2015 FDA 483 Response Galena Biopharma, Inc. - Form 483R, 2015-09-18
November, 2014 FDA 483 Beal G. Essink, MD - Form 483, 2014-11-06
June, 2014 FDA 483 Hiroshi's Enterprises, Inc. - Form 483, 2014-06-16
March, 2017 FDA 483 Response Compound Preferred LLC - Form 483R, 2017-03-22
November, 2014 FDA 483 Response Galena Biopharma, Inc. - Form 483R, 2014-12-11
March, 2015 EIR Matheson Tri-Gas, Inc. - EIR, 2015-03-04
June, 2016 EIR Bend Research Inc. - EIR, 2016-06-03
February, 2018 FDA 483 Yusef Manufacturing Laboratories, LLC DBA YMlabs, LLC - Form 483, 2018-03-05
July, 2018 FDA 483 Genentech, Inc. - Form 483, 2018-07-05
April, 2015 FDA 483 Paragon BioTeck, Inc. - Form 483, 2015-04-03
March, 2017 FDA 483 Compound Preferred LLC - Form 483, 2017-03-01
July, 2016 FDA 483 Trone Health Services, Inc. - Form 483, 2016-07-15
January, 2011 FDA 483 Uwajimaya, Inc. dba Kustom Foods - Form 483, 2011-01-25
August, 2018 FDA 483 Pharm D Solutions, LLC - Form 483, 2018-08-28
July, 2016 FDA 483 Response Trone Health Services, Inc. - Form 483R, 2016-08-03
May, 2015 FDA 483 Montana Compounding Pharmacy PC - Form 483, 2015-05-08
September, 2017 EIR Jubilant HollisterStier LLC - EIR, 2017-09-21
September, 2017 FDA 483 Jubilant HollisterStier LLC - Form 483, 2017-09-21
May, 2017 FDA 483 Option Care Enterprises, Inc. - Form 483, 2017-05-19
October, 2015 FDA 483 Response Cheta Nand, M.D. - Form 483R, 2015-11-25
October, 2015 EIR Cheta Nand, M.D. - EIR, 2015-10-30
November, 2014 FDA 483 Galena Biopharma, Inc. - Form 483, 2014-11-21

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