FDA Investigator Walden H Lee

Walden H Lee has conducted inspections on 93 sites in 16 countries as of 12 Mar 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
93
Last Inspection Date:
12 Mar 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
India, United States of America, Germany, New Zealand, Ireland, Australia, France, China, Finland, United Kingdom of Great Britain and Northern Ireland, Singapore, Canada, Israel, Italy, Switzerland
FDA Investigators that have inspected at least one site in common with Walden H Lee:
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, Althea A Williams, Amalia C Himaya, Amanda L Fyles, Amir Alavi, Anastasia M Shields, Anderson, Andrea A Branche, Andrea George, PhD, Andrea S Heise, Andrei Perlloni, Andrew J Gonzales, Andrew S Limson, Angel K Sandhu, 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 J Wilcox, PhD, Barbara Janine Breithaupt, Bernice F Hirsch, Bichsa T Tran, Bijoy Panicker, Binh T Nguyen, Blondell W Johnson, Bonita S Chester, Brandon C Heitmeier, 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, Carole L Jones, Carrie A Hughes, Caryn M Everly, Caryn M Mcnab, Cassandra L Abellard, Cathleen A Carr Sharpe, 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 Love 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, Crystal Monroy, Cynthia J Lee, MS, Cynthia J Tsui, Cynthia Jim, CSO, Dale A Nyberg, Damaris Y Hernandez, Daniel J Roberts, Darren S Brown, Darrin E Davis, David A Oluwo, David J Eide, David J Gomes, David Serrano, Dawn E Barkans, Deborah A Greco, Dejon N Harris, Demario L Walls, Derek S Smith, PhD, Desiree D Clark, 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, PhD, Dorothy P Kramer, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Durell L Giles, Dustin R Abaonza, Dyana K Stone, Eileen A Liu, Elaine A Bunch, Elizabeth Ad Girard, Elizabeth Juarez, Emily Shacter, Eric L Dong, BS, Erika V Butler, Evelyn Wong, Farhana Khan, Felix Maldonado, Finn A Slizza, Francis A Guidry, Freddy Ortiz Colon, Frederick L Fricke, Gabriel M Guevarra, Gam S Zamil, Gayle S Lawson, Gene D Arcy, George J Flynn, Gerald Feldman, Gerald M Feldman, PhD, 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, Henry K Lau, Heriberto Negron Rivera, Himanshu Gupta, PhD, Homero W Aguilar, 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 Evans, James R Fleckenstein, Jane S Wernberg, Janet D Blount, Jasmine N Thompson, Jason K Morgan, Jay T Wong, Jay V Jariwala, Jean M Mulinde, MD, Jeanne Fringer, PhD, 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, Joan M Cantellops Figueroa, Joan T Briones, Joanne Heim, Jocelyn C Turner, Jocelyn E Massey, Jocelyn E Sparks, Joe X Phillips, Joel D Hustedt, Joey V Quitania, Jogy George, John A Gonzalez, Jolanna A Norton, Jorge L Gonzalez, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose Martinez, Jr, Jose Ohernandez Guzman, Jose R Hernandez, Jose R Lopez, Jose Velez, Joseph A Piechocki, Joseph J Vannelli, Joseph Kutze, PhD, Joseph P Iser, MD, Joseph R Lambert, Joseph X Phillips, Joshua P Wireman, Joshua S Hunt, Juan J Casado, Juanita Banuelos, Juanj N Wu, 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 Cheung, Kelvin X Sanders, Kemejumaka N Opara, Kenneth H Williams, Kent C Faul, Kevin Lee, Kevin N Tran, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Kirtida Patel, Kristen D Evans, Kristin M Abaonza, Kristy A Zielny, Kristy E Zuroski, Lakecha N Lewis, Lakisha M Williams, Lance A Finnical, Lance Mde Souza, MBA, Larry K Austin, Lata C Mathew, PhD, Laurie P Norwood, Laurimer Kuilan Torres, LCDR Jennifer H Rhyu, LCDR Michael H Tollon, Leonard H Lavi, Li Hongpaul Yeh, PhD, Liatte Kreuger, PharmD, Lillian S Wu, Lilly O Barton, Liming Zhang, Linda F Murphy, Linda Thai, Lindsey M Schwierjohann, Ling Yu L Liu, Linh Tu, 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 Mburgos Medero, Luis P Torres, Lynda L Perry, PhD, Mabel M Lee, Mai X Huynh, Maida Henesian (NMI), Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marco S Esteves, Marcus F Yambot, Margaret M Annes, Marian E Ramirez, Marianela Aponte Cruz, Marie B Buen Bigornia, Marie F Morin, Marie Falcone, Marie K Kinkade, Marie T Falcone, Mariza M Jafary, Mark C Saale, Mark E Chan, Mark R Mcclain, Mark W Babbitt, Marsha W Major, Marshalette O Edwards, Mary R Hole, Massoud Motamed, Matthew B Casale, Matthew C Watson, Matthew R Clabeaux, Maurice M Sheehan, Meisha R Sampson, Meisha Waters, Melanie M Walker, Melba Trivera Clavell, Melissa J Garcia, Michael A Charles, Michael D Garcia, Michael D Kawalek, Michael R Goga, Michael S Araneta, Michael S Budziak, Michael S Call, Michael Shanks, MS, Michael T Cyrus, Michele L Obert, Michelle J Glembin, Michelle Rfrazier Jessen, PhD, Miguel A Martinez Perez, Mihaly S Ligmond, Min Shanmabel Liu, 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, Nicholas Obiri, PhD, Nicole E Knowlton, Niketa Patel, Norman K Starks, Omotunde O Osunsanmi, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patrick C Klotzbuecher, Paul A Bonneau, Penny H Mccarver, Peter C Chow, Peter E Baker, Peter Kessler, PhD, 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, Rebecca T Davis, Regina T Brown, Richard H Penta, Richmond K Yip, Riley C Myers, PhD, 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, Serge L Beaucage, Shannon B Ruelle, Sharna D Pratt, Sharon K Thoma, PharmD, Shawn R Gould, Sheilyn H Huang, Shelley H Beausoleil, Sherri J Jackson, Sherry G Bous, Shirshendu K Deb, PhD, Sidney B Priesmeyer, Sidonie J Takougang, Simone E Pitts, Sixto M Mercado Rios, Sonia R Peterson, Sonya L Karsik, RAC, Sparky L Bartee, Srinivas R Chennamaneni, PhD, Stacie A Woods, Stephanie A Slater, MS, Stephen D Eich, Stephen J Kilker, Steven A Brettler, Steven C Madzo, Steven D Kehoe, Steven E Porter, Jr, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Stuart W Russell, Sue Lee Chan, Sumit Sen, Sundy V Sedwick, Susan D Yuscius, Susan F Laska, MS, Susan P Bruederle, Susanna E Ford, Susanne M Richardson, MS RAC, Suzanne N Vallez, 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, Thea C Grome, Theresa Kirkham (NMI), Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy C Grome, Timothy T Kapsala, Tina M Pawlowski, Tony J Wu, Tonya R Johnson, Tracey T Duong, Trudy R Papson, 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, Wayne T Smith, Wenzheng Wendy Zhang, William J Leonard, William V Millar, Xiaohui Shen, Xikui Chen (nmi), PhD, Yasamin Ameri, Yi Wang, PhD, Yumi J Hiramine, Yvesna C Blaise, Yvette E Guillermo, 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
July, 2019 FDA 483 Taro Pharmaceutical Industries Ltd. - Form 483, 2019-07-11
October, 2013 EIR ASEGUA THERAPEUTICS LLC - EIR, 2013-10-09
February, 2017 FDA 483 Bachem Americas, Inc. - Form 483, 2017-02-10
March, 2022 FDA 483 Nanoimaging Services, Inc. - Form 483, 2022-03-03
March, 2007 FDA 483 Watson Laboratories, Inc. - Form 483, 2007-03-09
November, 2019 FDA 483 ATLAS ANALYTICAL INC - Form 483, 2019-11-14
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
July, 2014 EIR ASEGUA THERAPEUTICS LLC - EIR, 2014-07-25
July, 2020 EIR B. Braun Medical Inc. - EIR, 2020-07-23
June, 2015 FDA 483 Avara Pharmaceutical Technologies, Inc. - Form 483, 2015-06-24
June, 2018 FDA 483 Response B. Braun Medical Inc. - Form 483R, 2018-07-23
December, 2023 FDA 483 Med-Pharmex, Inc - Form 483, 2023-12-18
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
January, 2020 FDA 483 Cipla Ltd. - Form 483, 2020-01-24
April, 2011 EIR Sun Pharmaceutical Industries Limited - EIR, 2011-04-07
September, 2000 EIR Watson Laboratories, Inc. - EIR, 2000-09-14
August, 2009 EIR Apotex Inc. - EIR, 2009-08-14
January, 2008 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2008-01-23
August, 2021 FDA 483 Response Teva Parenteral Medicines, Inc. - Form 483R, 2021-09-13
November, 2001 EIR Paklab - EIR, 2001-11-09
March, 2001 FDA 483 Response Truett Laboratories, Inc. - Form 483R, 2001-06-04
October, 2019 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2019-10-25
March, 2001 FDA 483 Truett Laboratories, Inc. - Form 483, 2001-03-16
August, 2021 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2021-08-20
October, 2019 EIR Stason Pharmaceuticals, Inc. - EIR, 2019-10-25
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
July, 2019 FDA 483 Dead Sea Periclase - Form 483, 2019-07-18
October, 2019 FDA 483 Response Stason Pharmaceuticals, Inc. - Form 483R, 2019-10-25
February, 2019 FDA 483 Emcure Pharmaceuticals Limited - Form 483, 2019-02-20
March, 2020 FDA 483 Front Range Laboratories, Inc. - Form 483, 2020-03-20
March, 2016 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2016-03-08
June, 2013 FDA 483 PCAS - Form 483, 2013-06-27
August, 2019 FDA 483 University of Southern California DBA USC Molecular Imaging Center - Form 483, 2019-08-14
March, 2001 EIR Truett Laboratories, Inc. - EIR, 2001-03-16
April, 2014 FDA 483 SMS Pharmaceuticals Limited - Form 483, 2014-04-18
July, 2003 FDA 483 GRAM Laboratories, Inc. - Form 483, 2003-07-31
November, 2017 EIR Nitto Avecia Pharma Services, Inc. - EIR, 2017-11-02
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
August, 2009 FDA 483 Apotex Inc. - Form 483, 2009-08-14
June, 2015 EIR Avara Pharmaceutical Technologies, Inc. - EIR, 2015-06-24
August, 2009 FDA 483 Response Apotex Inc. - Form 483R, 2009-09-03
May, 2019 FDA 483 Med-Pharmex, Inc - Form 483, 2019-05-30
October, 2013 FDA 483 Response ASEGUA THERAPEUTICS LLC - Form 483R, 2013-10-31
July, 2014 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2014-07-25
October, 2013 FDA 483 ASEGUA THERAPEUTICS LLC - Form 483, 2013-10-09
June, 2018 EIR B. Braun Medical Inc. - EIR, 2018-06-29
February, 2024 FDA 483 Nephron SC Inc. - Form 483, 2024-02-09
March, 2017 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2017-03-31
April, 2017 FDA 483 Response Sparsha Pharma USA, Inc. - Form 483R, 2017-05-18
January, 2019 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2019-01-18
April, 2014 FDA 483 LAURUS LABS LIMITED - Form 483, 2014-04-25
February, 2017 EIR Bachem Americas, Inc. - EIR, 2017-02-10
March, 2019 FDA 483 EUGIA SEZ PRIVATE LIMITED - Form 483, 2019-03-01
November, 2015 FDA 483 AMINO GmbH - Form 483, 2015-11-13
February, 2009 FDA 483 Emcure Pharmaceuticals Limited - Form 483, 2009-02-19
February, 2000 FDA 483 Teva Parenteral Medicines, Inc. - Form 483, 2000-02-25
July, 2012 FDA 483 Micro Labs Limited - Form 483, 2012-07-31
February, 2000 EIR Teva Parenteral Medicines, Inc. - EIR, 2000-02-25
October, 2012 FDA 483 Heron Therapeutics, Inc. - Form 483, 2012-10-19
June, 2015 FDA 483 Response Avara Pharmaceutical Technologies, Inc. - Form 483R, 2015-06-24
March, 2024 FDA 483 Amphastar Pharmaceuticals, Inc. - Form 483, 2024-03-01
June, 2018 FDA 483 B. Braun Medical Inc. - Form 483, 2018-06-29
June, 2024 FDA 483 Jubilant HollisterStier LLC - Form 483, 2024-06-06
May, 2024 FDA 483 Polypeptide Laboratories, Inc. - Form 483, 2024-05-10

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