FDA Investigator Walden H Lee

Walden H Lee has inspections in 15 countries as of 13 Oct 2023. Walden H Lee has collaborated with a combinined 8161 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
89
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100004051
Country:
India, Germany, Australia, New Zealand, United Kingdom of Great Britain and Northern Ireland, United States of America, Switzerland, Italy, Israel, Singapore, China, Ireland, Finland, France, Canada
Co-Investigator(s):
Adam R Cooke, Ademola O Daramola, Aditi S Thakur, Alan L Truong, Alan P Kurtzberg, Alexandra B Pitkin, Alexandria L Capuano, Alicia M Mozzachio, Allen F Hall, Amalia C Himaya, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Andrea S Heise, Andrei Perlloni, Andrew J Gonzales, Andrew S Limson, Angela E Glenn, Anh M Lac, Anissa M Vargas, Anita Narula, PhD, Ann L Demarco, Anna Lazar, April P Shaw, Arie C Menachem, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arsen Karapetyan, Ashar P Parikh, Aurora Miha Trifanov, Azza Talaat, Barbara D Wright, Barbara J Rincon, Barbara Janine Breithaupt, Bernice F Hirsch, Bichsa T Nguyen, Bichsa T Tran, Bijoy Panicker, Binh T Nguyen, Blondell W Johnson, Bonita S Chester, Brian J Ryan, Brian L Belz, Brian P Putz, Brittany D Terhar, Brooke K Higgins, Bryan A Galvez, Bryan S Roddy, Calvin B Koerner, Camerson E Moore, Carl Lee, Carla J Lundi, Carr Sharpe, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Cecilia H Kieu, Charanjeet Jassal, Charisse K Green, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheryl A Clausen, Cheryl Llove Harris, Chilton L Ng, Christine W Twohy, Christopher J Freebairn, Christopher M Hernandez, Christopher M Jenner, Christopher M Reed, Christopher N Tran, Christopher R Czajka, Claudia Mperez Kasmarski, Comyar Shoghi, Concepcion Cruz, Jr, Craig A Garmendia, Cynthia J Lee, MS, Cynthia Jim, CSO, Dale A Nyberg, Daniel J Roberts, Darren S Brown, Darrin E Davis, David A Oluwo, David J Eide, David Serrano, Dawn E Barkans, Deborah A Greco, Dejon N Harris, Derek S Smith, PhD, Devaugh Edwards, Devaughn Edwards, Diana M Rand, Diane Cvan Leeuwen, Diane R Weidley, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Dogbeda F Mackenzie, Dongping Dai, PhD, Donna Mwilliams Hill, Dorothy P Kramer, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Robert C Horan, MD, Dustin R Abaonza, Dyana K Stone, Eileen A Liu, Elaine A Bunch, Elizabeth A Girard, Elizabeth Ad Girard, Elizabeth Juarez, Eric L Dong, BS, Erika V Butler, Evelyn Wong, Farhana Khan, Felix Maldonado, Francis A Guidry, Freddy Ortiz Colon, Frederick Fricke, Frederick L Fricke, Gabriel Guevarra, Gabriel M Guevarra, Gam S Zamil, Gayle S Lawson, Gene D Arcy, George J Flynn, Geraldine H Matining, Geraldine M Peregrin, Greg K Keshishyan, Gregory A Berg, Gwyn G Dickinson, Haitao Li, Hala L Selby, Haroon Vohra (NMI), Heidy C Perales, Helen B Ricalde, Heriberto Negron Rivera, Himanshu Gupta, PhD, Hoover, Hossein Khorshidi, PhD, Iris C Macinnes, Jacob G Lutz, Jai P Singh, James A Lane, James B Arnett, James C Lee, PharmD, James C Maclaughlin, James I Giefer, James M Mason, James R Fleckenstein, Jane S Wernberg, Janet Blount, Janet D Bart, Jasmine N Thompson, Jason K Morgan, Jay T Wong, Jay V Jariwala, Jean M Mulinde, MD, Jeffery A Hangartner, Jeffery A Johnson, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer L Degroot, Jennifer L Gustavus, Jennifer L Johnson, Jennifer M Gogley, Jeremiah D Beckwith, Jeremy W Rotton, Jessica L Pressley, Jinnie Kokiatkulkij, Joanne Heim, Jocelyn C Turner, Joe X Phillips, Joel D Hustedt, Joey V Quitania, Jogy George, John A Gonzales, John A Gonzalez, Jolanna A Norton, Jorge L Gonzalez, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Jose O Hernandez, Jose R Hernandez, Jose R Lopez, Jose Velez, Joseph J Vannelli, Joseph R Lambert, Joseph X Philips, Joseph X Phillips, Joshua P Wireman, Juan J Casado, Judy C Nepsa, Julia Ventura, June P Page, Junho Pak, Justin A Boyd, Ka L Wong, Karen A Wolnik, Karen D Phung, Kari M Johansen, Karl D Hezel, Katherine E Jacobitz, Katherine Szestypalow, Kathryn E Ogger, Kathy Chiu, Kathy Kuo, Kejun Cheng, Kelley, Kellia N Hicks, Kelly I Anderson, Kelvin X Sanders, Kenneth H Williams, Kent C Faul, Kevin Lee, Kevin P Foley, Kham Phommachang, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Kimerley A Hoefen, Kirtida Patel, Kristen D Evans, Kristin M Abaonza, Kristy A Zielny, Kristy E Zuroski, Lakecha N Lewis, Lance A Finnical, Lance M De Souza, MBA, Langer, Larry K Austin, Lata C Mathew, PhD, Laurimer Kuilan Torres, LCDR Jennifer H Rhyu, LCDR Michael H Tollon, Lee, Leonard H Lavi, Li Hongpaul Yeh, PhD, Liatte Kreuger, PharmD, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda Thai, Lindsey M Schwierjohann, Ling Yul Liu, Lisa M Schultz, Lisa R Hilliar, Lisa Shin, Lixia Cai, Lloyd D Payne, Loretta J Jordan, LT Richard A Lyght, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis A Dasta, Luis M Burgos Medero, Lynda L Perry, PhD, Mai X Huynh, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marco S Esteves, Marcus F Yambot, Margaret M Annes, Marian E Ramirez, Marianela Aponte Cruz, Marie Bbuen Bigornia, Marie F Morin, Marie Falcone, Marie K Kinkade, Marie T Falcone, Mariza M Jafary, Mariza M Jalary, Mark C Saale, Mark E Chan, Mark R Mcclain, Mark W Babbitt, Marshalette O Edwards, Mary K Kinkade, Mary R Hole, Massoud Motamed, Matthew B Casale, Matthew C Watson, Matthew R Clabeaux, Maurice M Sheehan, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melissa J Garcia, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael R Goga, Michael S Araneta, Michael S Call, Michele L Obert, Michelle J Glembin, Miguel A Martinez, Mihaly S Ligmond, Minh D Phan, Monica Cburgos Garcia, Monica E Caphart, Monika Borkowska, Mra Mcculloughj, Muralidhara B Gavini, PhD, Nabeela J Chaudhry, Nadeem I Chaudhry, Nancy G Schmidt, Nancy Haggard, Nayan J Patel, Nelly N Tran, Nicholas L Hunt, Nicholas L Paulin, Nicole E Knowlton, Niketa Patel, Norman K Starks, Omotunde O Osunsanmi, Pabhu P Raju, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patrick C Klotzbuecher, Paul A Bonneau, Penny H Mccarver, Peter C Chow, Peter E Baker, Philip F Istafanos, DMV, MS, Prabhu P Raju, Pratik S Upadhyay, DDC, Rachel C Stanton, Rafael Nevarez Nieves, Ralph H Vocque, Randall N Johnson, Ravi S Harapanhalli, Raymond T Oji, Rebecca E Dombrowski, Rebecca Rodriguez, Regina T Brown, Richard H Penta, Richmond K Yip, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert J Ham, Robert J Martin, Rocio Guzman Velazquez, Rodney G Raiford, Roger F Zabinski, Ross J Grigsby, Rozelle G Smith, Rumany C Penn, PharmD, Russell J Glapion, Ruth Moore, PhD, Ryan J Borges, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Sandra A Boyd, Sandra A Hughes, Sandra L Shire, DMD, MPA, Sandra S Saniga, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah E Mcmullen, Sarah Ibrahim, Satheesh Thomas, Saundrea A Munroe, Scott B Laufenberg, Scott N Lim, Scott T Ballard, Sean P Desbrow, Selene T Torres, Shannon B Ruelle, Sharon K Thoma, PharmD, Sharon K Thomas, Shawn R Gould, Shelby N Marler, Sherry G Bous, Shirshendu K Deb, PhD, Sidonie J Takougang, Simone E Pitts, Sixto M Mercado Rios, Sonia R Peterson, Sonya L Karsik, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stacie A Woods, Stephanie A Slater, MS, Stephen J Kilker, Steven C Madzo, Steven D Kehoe, Steven E Porter, Jr, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Sue Lee Chan, Sumit Sen, Sundy Ven, Susan D Yuscius, Susan F Laska, MS, Susan P Bruederle, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Taichun Qin, PhD, Tajah L Blackburn, Tamala P Bogan, Tamala P Magee, Tamil Arasu, PhD, Tawny L Colling, Temar Q Williams, Teresa I Navas, Terri L Dodds, Thanh M Andrews, Thao T Kwan, Thao X Tran, That T Kwan, Theresa Kirkham (NMI), Thomas J Arista, Tiara M Brown, Tiara Nbrown Crosen, Timothy T Kapsala, Tina M Pawlowski, Tony J Wu, Tonya R Johnson, Tracey T Duong, Truong Xuan Nguyen (Andy), Tsedenia Woldehanna, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie L Whipp, Vashti E Bocker, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Vlada Matusovsky, Walden Lee, Wayne T Smith, Wenzheng Zhang, William J Leonard, William V Millar, Xiaohui Shen, Xikui Chen (nmi), PhD, Yasamin Ameri, Yumi J Hiramine, Yvesna C Blaise, Yvonne Y Wu, Zachary A Bogorad, Zachary L Miller, Zhaoyang Meng, Zhong Li, PhD, Zhongren Wu

Walden H Lee's Documents

Publish Date Document Type Title
November, 2001 EIR Paklab - EIR, 2001-11-09
January, 2020 FDA 483 CIPLA LIMITED - Form 483, 2020-01-24
March, 2017 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2017-03-31
October, 2013 FDA 483 Response ASEGUA THERAPEUTICS LLC - Form 483R, 2013-10-31
August, 2021 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2021-08-20
September, 2000 EIR Watson Laboratories, Inc. - EIR, 2000-09-14
July, 2014 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2014-07-25
March, 2001 FDA 483 Response Truett Laboratories, Inc. - Form 483R, 2001-06-04
February, 2017 EIR Bachem Americas, Inc. - EIR, 2017-02-10
April, 2017 FDA 483 Sparsha Pharma USA, Inc. - Form 483, 2017-04-28
February, 2013 FDA 483 Impax Laboratories, LLC. - Form 483, 2013-02-28
June, 2015 FDA 483 Response Avara Pharmaceutical Technologies, Inc. - Form 483R, 2015-06-24
June, 2018 EIR B. Braun Medical Inc. - EIR, 2018-06-29
July, 2012 FDA 483 Micro Labs Limited - Form 483, 2012-07-31
February, 2000 EIR Teva Parenteral Medicines, Inc. - EIR, 2000-02-25
April, 2014 FDA 483 SMS Pharmaceuticals Limited - Form 483, 2014-04-18
July, 2020 EIR B. Braun Medical Inc. - EIR, 2020-07-23
November, 2017 EIR Nitto Avecia Pharma Services, Inc. - EIR, 2017-11-02
October, 2019 FDA 483 Response Stason Pharmaceuticals, Inc. - Form 483R, 2019-10-25
October, 2019 EIR Stason Pharmaceuticals, Inc. - EIR, 2019-10-25
February, 2017 FDA 483 Response Bachem Americas, Inc. - Form 483R, 2018-09-10
March, 2021 FDA 483 ADAMSON ANALYTICAL LABORATORIES INC - Form 483, 2021-03-23
October, 2013 EIR ASEGUA THERAPEUTICS LLC - EIR, 2013-10-09
March, 2001 FDA 483 Truett Laboratories, Inc. - Form 483, 2001-03-16
June, 2013 FDA 483 PCAS - Form 483, 2013-06-27
March, 2001 EIR Truett Laboratories, Inc. - EIR, 2001-03-16
October, 2019 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2019-10-25
August, 2009 EIR Apotex Inc. - EIR, 2009-08-14
October, 2012 FDA 483 Heron Therapeutics, Inc. - Form 483, 2012-10-19
August, 2009 FDA 483 Apotex Inc. - Form 483, 2009-08-14
January, 2019 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2019-01-18
July, 2019 FDA 483 Dead Sea Periclase - Form 483, 2019-07-18
July, 2003 FDA 483 GRAM Laboratories, Inc. - Form 483, 2003-07-31
June, 2015 FDA 483 Avara Pharmaceutical Technologies, Inc. - Form 483, 2015-06-24
March, 2016 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2016-03-08
November, 2015 FDA 483 AMINO GmbH - Form 483, 2015-11-13
June, 2018 FDA 483 Response B. Braun Medical Inc. - Form 483R, 2018-07-23
February, 2000 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2000-02-25
April, 2011 EIR Sun Pharmaceutical Industries Limited - EIR, 2011-04-07
January, 2008 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2008-01-23
March, 2019 FDA 483 Eugia SEZ Private Limited - Form 483, 2019-03-01
July, 2020 FDA 483 B. Braun Medical Inc. - Form 483, 2020-07-23
March, 2021 FDA 483 Response ADAMSON ANALYTICAL LABORATORIES INC - Form 483R, 2021-04-12
March, 2007 FDA 483 Watson Laboratories, Inc. - Form 483, 2007-03-09
August, 2009 FDA 483 Response Apotex Inc. - Form 483R, 2009-09-03
February, 2019 FDA 483 Emcure Pharmaceuticals Limited - Form 483, 2019-02-20
June, 2018 FDA 483 B. Braun Medical Inc. - Form 483, 2018-06-29
July, 2014 EIR ASEGUA THERAPEUTICS LLC - EIR, 2014-07-25
February, 2017 FDA 483 Bachem Americas, Inc. - Form 483, 2017-02-10
February, 2009 FDA 483 Emcure Pharmaceuticals Limited - Form 483, 2009-02-19
July, 2019 FDA 483 Taro Pharmaceutical Industries Ltd. - Form 483, 2019-07-11
March, 2020 FDA 483 Front Range Laboratories, Inc. - Form 483, 2020-03-20
June, 2015 EIR Avara Pharmaceutical Technologies, Inc. - EIR, 2015-06-24
April, 2014 FDA 483 LAURUS LABS LIMITED - Form 483, 2014-04-25
August, 2021 FDA 483 Response Teva Parenteral Medicines, Inc. - Form 483R, 2021-09-13
October, 2013 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2013-10-09
May, 2019 FDA 483 Med-Pharmex, Inc - Form 483, 2019-05-30
September, 2010 FDA 483 Huzhou Zhanwang Pharmaceutical Co., Ltd. - Form 483, 2010-09-16
November, 2017 FDA 483 Nitto Avecia Pharma Services, Inc. - Form 483, 2017-11-02
November, 2019 FDA 483 ATLAS ANALYTICAL INC - Form 483, 2019-11-14
April, 2017 FDA 483 Response Sparsha Pharma USA, Inc. - Form 483R, 2017-05-18
August, 2019 FDA 483 University of Southern California DBA USC Molecular Imaging Center - Form 483, 2019-08-14
December, 2023 FDA 483 Med-Pharmex, Inc - Form 483, 2023-12-18

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