FDA Investigator Junho Pak

Junho Pak has conducted inspections on 112 sites in 18 countries as of 16 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
112
Last Inspection Date:
16 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Netherlands, Japan, Germany, China, Spain, India, Korea (Republic of), Ireland, United Kingdom of Great Britain and Northern Ireland, Italy, Greece, Switzerland, Singapore, Austria, France, Brazil, Thailand
FDA Investigators that have inspected at least one site in common with Junho Pak:
Adam R Cooke, Adetutu M Gidado, Akilah K Green, Alan P Kurtzberg, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Alison N Correll, Alison N Stieg, Alla Kachko, PhD, Allison A Aldridge, PhD, Amalia C Himaya, Amit Kokate, Amy N Chen, Anastasia I Offordile, Anastasia M Shields, Andrea A Branche, Andrew J Barrowcliff, Andrew Le, Angela E Glenn, Anissa M Cheung, Anita Narula, PhD, Anita R Michael, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Annemarie Bodnar, Annet R Rajan, Anthony A Charity, Anthony C Taube, Anthony C Warchut, April L Young, Arsen Karapetyan, Arthur T Ogdahl, Arulvathani P Arudchandran, Ashar P Parikh, Audrey Thereset Uy, Azza Talaat, Bapu R Gaddam, Barbara A Gullick, Barbara J Maulfair, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barry Cherney, PhD, Bichsa T Tran, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brentley S Collins, Brian D Nicholson, Brian D Young, Brian S Keefer, Brien C Fox, Brittany D Terhar, Brooke K Higgins, Brooke K Seeman, Bruce G Cooper, Bruce H Mccullough, Burnell M Henry, Carl A Huffman, III, Carla A Norris, Carla J Lundi, Cary Greene, Caryn M Mcnab, CDR Jeremy L Wally, PhD, Chaltu Nwakijra, Chao Ming Tsai, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Cheron M Portee, Cheryl A Clausen, Chiang Syin, PhD, Christian D Lynch (CDL), Christina C Santos, Christina Capacci Daniel, PhD, Christina J Sauder, PhD, Christina K Theodorou, Christina V Santos, Christopher D Leach, Christopher J Adams, Claire M Minden, Cody D Rickman, Concepcion Cruz, Jr, Constantin Y Philopoulos, Craig D Zagata, Crystal A Harlan, Cynthia A Palmer, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia T Cain, Dandan Wang, PhD, Daniel J Grabicki, Daniel J Min, Daniel J Roberts, Daniel L Obrzut, Daniel L Zheng, Daniel W Cline, Darren S Brown, Daryl A Dewoskin, Dave Hafner, David A Oluwo, David Doleski, David J Claffey, David J Gomes, David J Hafner, David M Mcnew, Davinna Ligons, PhD, Deborah A Greco, Deborah J Parris, Debra I Love, Debra J Bennett, Debra L Pagano, Denise M Digiulio, Dennis Cantellops Paite, Derek S Dealy, Deyaa Shaheen, Diane Cvan Leeuwen, Diane L Raccasi, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Donna Ltartaglino Besone, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Dominick Roselle, Dr. Gang Wang, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Roslyn F Powers, Dr. Yubing Tang, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Edward D Mcdonald, Edwin Melendez, Eileen A Liu, Elizabeth Ll Edwards, Ellen Huang, Emest F Bizjak, Emmanuel Jramos Maldonado, Eric L Dong, BS, Erika M Wilkerson, Erika V Butler, Erin D Mccaffery, Esther C Broner, PhD, Evan Tong, Farhana Khan, Feiyan Jin, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Gam S Zamil, Gayle S Lawson, Gene D Arcy, Geoffrey K Wong, George C Amedro, George Pyramides, Gerald B Seaborn, Jr, Gerard D Difiore, Gloria E Parra, Grace E Mcnally, Gregory D Dixon, Guerlain Ulysse, Hala L Selby, Hala Lj Whetstone, Haley H Seymour, Hao Kiet D Phan, Haoheng Yan, PhD, Haroon Vohra (NMI), Haruhiko Murata, Hasan A Irier, PhD, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hung H Do, MS, Hyung Yul Lee, Iris C Macinnes, Israel Santiago, OCM, Ivis L Negron, J David Doleski, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, Jaison J Eapen, James C Maclaughlin, James D Bridges, James I Giefer, James L Dunnie, Jr, James M Mason, James M Simpson, James P Stumpff, James R Fleckenstein, Janet A Rajan, Janet L Bowen, Jared P Stevens, Javier E Santos, Javier O Vega, Jazmine N Brown, Jee Chung, PhD, Jeffery A Hangartner, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer Gogley, Jennifer L Huntington, Jennifer M Gogley, Jeremy W Rotton, Jessica S Estriplet, Jing Fang, Joan A Loreng, Joan Adamo, Joanne E King, Joanne M Hajoway, Joel D Hustedt, Joel Welch, PhD, Joey V Quitania, Jogy George, John P Mistler, John R Myung, Jonah S Ufferfilge, Jonathan G Matrisciano, Jonathan W Chapman, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose R Hernandez, Joseph George, Joseph L Despins, PhD, Joseph R Haynes, Joseph W Matthews, Juan Rjimenez Garcia, Juanita P Versace, Juliana M Badalucco, Julianne C Mccullough, Julie D Bringger, June P Page, Justin A Boyd, Justine Tomasso, Ka L Wong, Kara A Scheibner, PhD, Karen A Briggs, Karen C Daugherty, Karen E D'orazio, Karen L Kosar, Karen Takahashi, Karishma G Gopaul, Karl D Hezel, Karyn M Campbell, Katherine Szestypalow, Kathleen B Mihalik, Kathleen B Swat, Kathleen M Jordan, Kathleen R Jones, PhD, Kathryn Carbone, MD, Kejun Cheng, Kellia N Hicks, Kelly N Kerr, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kendra L Brooks, Kenneth G Klobus, Kenneth M Gordon, Kenneth Nieves, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Kim Lthomas Cruse, Ko U Min, Krishna Ghosh, PhD, Kristen D Evans, Kristin M Abaonza, Kristina J Donohue, Kristina L Conroy, Kristy A Zielny, Kshitij A Patkar, Kumar G Janoria, Kurt A Brorson, PhD, Lakshmi Narasimhan, PhD, Lance Mde Souza, MBA, Lane V Christensen, PhD, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Laurel A Beer, Lauren L Vajo, Lauren N Barber, Lawrence Harmon, Jr, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Margaret Edi Gennaro, LCDR Susan E Polifko, Leonard H Lavi, Lequita M Mayhew, Li Hongpaul Yeh, PhD, Lillian S Wu, Linda F Murphy, Linda M Hoover, Linda Thai, Lindsey S Fleischman, Lisa B Orr, Lisa M Bellows, Lisa M Feola, Lisa R Hilliar, Lixia Cai, Lixin Xu, MD, PhD, Lori B Wikstrom, Lori S Lawless, LT John M Mastalski, LTJG Bradley E Benasutti, Lucas B Leake, Luella J Rossi, Luis A Dasta, Luis Mburgos Medero, Lydia I Rosas Marty, Madushini Dharmasena, PhD, Makini Cobourne Duval, PhD, Marc S Neubauer, Marcellinus D Dordunoo, Marcia B Williams, Marcus A Ray, Marcus F Yambot, Margaret M Annes, Margaret M Doherty, Maria A Reed, Maria Cecilia Tami, PhD, Maria Gutierrez Hoffman, PhD, Marian E Major, PhD, Marianela Aponte Cruz, Marie F Morin, Mark D Johnson, Mark R Mcclain, Marvin D Jones, Matthew A Spataro, Matthew B Casale, Matthew M Henciak, Matthew R Noonan, Maxyne T Lam, Meena Bansal Gupta, PhD, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Meyer J Slobotsky, Michael A Charles, Michael A Taylor, Michael Curbarg, Michael E Maselli, Michael Gurbarg, Michael J Nerz, Michael L Casner, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michael W Burd, Michele Gottshall, Michele L Forster, PhD, Michele L Obert, Michele M Falchek, Michelle A Marsh, Michelle J Glembin, Miguel A Martinez Perez, Mihaly S Ligmond, Milos Dokmanovic, PhD, Minh D Phan, Mohsen Rajabi Abhari, FDA, Monica Cburgos Garcia, Monica M Mcclure, Monika Borkowska, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra Narulaa, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy F Scheraga, Nancy G Schmidt, Nancy M Espinal, Nancy T Waites, Nayan J Patel, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Nicholas A Violand, Nicholas C Mendiola, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole E Knowlton, Nicole K Trudel, Nikisha M Bolden, Noreen Muñiz, Ogechi C Nna, Omotunde O Osunsanmi, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paula A Trost, Paula J Bretz, Peter Adams, PhD, Peter E Baker, Peter S Diak, Prabhu P Raju, Pratik S Upadhyay, DDC, Qin Xu, Qing Joanna Zhou, PhD, Rabin N Ghoshal, Rachael A Moliver, Rachael O Oyewole, Rachel C Harrington, Raffi B Papazian, Rajiv R Srivastava, Ramon A Hernandez, Ramon E Martinez, Randy L Self, Raquel Gonzalez Rivera, Reba A Gates, Rebecca K Olin, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard Ledwidge (nmi), PhD, Richmond K Yip, Riley C Myers, PhD, Rita K Kabaso, Robert B Shibuya, MD, Robert C Coleman, Robert D Tollefsen, Robert Darius, Robert H Wittorf, Robert J Doyle, Robert J Maffei, Robert J Martin, Robert M Barbosa, Robin P Mathew, Rochelle K Kimmel, Rodney G Raiford, Roger F Zabinski, Rona Leblanc, PhD, Ronald G Crawford, Ronald L Koller, Ronda Leblanc, Rose Ashley, Rose Xu, Rowena S Nguyen, Russ E Davis, Russell J Glapion, Ruth Moore, PhD, S Lori Brown, PhD MPH, Sachinkumar V Patel, Saleem A Akhtar, Salvatore N Randazzo, Sam Pepe, Samantha J Bradley, Samina S Khan, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Santos E Camara, Sarah Arden, Sarah Johnson, PhD, Sasha M Latonis, Satheesh Thomas, Scott E Norris, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sena G Dissmeyer, Seongeun Cho (Julia), PhD, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Shelley L Waring, Shirley J Berryman, Shirley S Wen, Shirshendu K Deb, PhD, Shuang Tang, Sidney B Priesmeyer, Simone E Pitts, Sixto M Mercado Rios, Sonia R Peterson, Sony Mathews, Sri Ramakrishnaiah Yellela, PhD, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey S Degarmo, Stanley Au, Stephanie A Slater, MS, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen J Koniers, Stephen J Mottola, Steven A Rubin, Steven D Kehoe, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Stuart W Russell, Suchan Kim, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan T Hadman, Susan W Ting, Susanna E Ford, Syeda N Mahazabin, Taichun Qin, PhD, Tajah L Blackburn, Tamara L Ely, Tamika White, Tamil Arasu, PhD, Tammy L Chavis, Tara G Bizjak, Temar Q Williams, Terri L Dodds, Thao T Kwan, Thao X Tran, Theressa B Smith, Thomas E Friel, Thomas J Arista, Thomas R Withers, Thomas W Nojek, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiffani D Wilson, Timothy T Kapsala, Tina S Roecklein, Todd M Stankewicz, Tonia F Bernard, Toyin B Oladimeji, Tricia S Martinez, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Vilmary Negron Rodriguez, Viviana Matta, Vivin George, Vlada Matusovsky, Walden H Lee, Walter L Fava, Wanda Y Honeyblue, Wayne D Mcgrath, Wayne E Seifert, Wei Wang, PhD, Wen Ning Chan (Sally), William J Leonard, Xiao Wang, Xiaokuang Lai, PhD, Xu Michael Di, PhD, Yanming An, PhD, Yasamin Ameri, Yoriann M Cabrera Bartolomei, Yumi J Hiramine, Yun Wu, PhD, Yvesna C Blaise, Yvins Dezan, Yvonne C Wilkes, Zakaria I Ganiyu, Zhaoyang Meng, Zhong Li, PhD, Zhongren Wu, Zhouxi Wang, Ziyang Su, PhD

Junho Pak's Documents

Publish Date Document Type Title
December, 2017 FDA 483 Response Ingenus Pharmaceuticals NJ LLC - Form 483R, 2018-01-05
June, 2019 FDA 483 Laboratorio Reig Jofre Sa. - Form 483, 2019-06-14
August, 2012 FDA 483 LONZA BIOLOGICS TUAS PTE. LTD. - Form 483, 2012-08-03
April, 2017 FDA 483 Wyeth Lederle SRL - Form 483, 2017-04-20
October, 2016 FDA 483 Intas Pharmaceuticals Limited - Form 483, 2016-10-19
June, 2017 FDA 483 KVK-TECH, INC - Form 483, 2017-06-27
September, 2018 FDA 483 KVK-TECH, INC - Form 483, 2018-09-21
May, 2023 FDA 483 Dr. Reddy's Laboratories Limited - Form 483, 2023-05-12
October, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-10-30
January, 2015 FDA 483 Response Abbey Color Incorporated - Form 483R, 2015-02-10
October, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-10-30
August, 2022 FDA 483 AARKISH PHARMACEUTICALS NJ INC. - Form 483, 2022-08-18
May, 2023 FDA 483 Apitoria Pharma Private Limited - Form 483, 2023-05-19
October, 2020 FDA 483 Pharmaceutics International, Inc. - Form 483, 2020-10-30
May, 2022 FDA 483 Sartorius Korea Biotech Co., LLC. - Form 483, 2022-05-20
January, 2020 FDA 483 IOI Oleo GmbH - Form 483, 2020-01-17
October, 2017 EIR PHARMATHEN INTERNATIONAL S.A. - EIR, 2017-10-26
September, 2021 FDA 483 SEAWAY PHARMA - Form 483, 2021-09-15
June, 2016 FDA 483 Amgen, Inc - Form 483, 2016-06-06
June, 2021 FDA 483 KVK-TECH, INC - Form 483, 2021-06-11
August, 2017 FDA 483 Graviti Pharmaceuticals Private Limited - Form 483, 2017-08-04
November, 2021 FDA 483 Micron Inc - Form 483, 2021-11-05
October, 2018 FDA 483 Response Dr Reddy's Laboratories Limited - Form 483R, 2018-11-20
March, 2016 FDA 483 Korea Mcnulty Co., Ltd. - Form 483, 2016-03-04
February, 2019 FDA 483 Alfresa Fine Chemical Corporation - Form 483, 2019-02-08
May, 2018 FDA 483 MERCK SERONO SA - Form 483, 2018-05-09
November, 2014 FDA 483 Ferring GmbH - Form 483, 2014-11-11
November, 2019 FDA 483 Gland Pharma Limited - Form 483, 2019-11-01
July, 2015 EIR Medical Products Laboratories, Inc. - EIR, 2015-07-21
October, 2018 FDA 483 Dr Reddy's Laboratories Limited - Form 483, 2018-10-30
October, 2016 FDA 483 CAPLIN STERILES LIMITED - Form 483, 2016-10-28
September, 2010 FDA 483 Eurofins Lancaster Laboratories, Inc - Form 483, 2010-09-07
November, 2015 FDA 483 Beyond Technology Corporation Nanchang - Form 483, 2015-11-11
October, 2022 FDA 483 Pfizer Healthcare India Private Limited - Form 483, 2022-10-18
December, 2017 EIR Ingenus Pharmaceuticals NJ LLC - EIR, 2017-12-14
July, 2015 FDA 483 Medical Products Laboratories, Inc. - Form 483, 2015-07-21
June, 2022 FDA 483 CELLTRION Inc - Form 483, 2022-06-03
February, 2018 FDA 483 DSM Nutritional Products GmbH - Form 483, 2018-02-02
August, 2013 FDA 483 Novel Laboratories, Inc. - Form 483, 2013-09-11
January, 2020 EIR Patheon Austria GmbH & CoKG - EIR, 2020-01-31
October, 2017 FDA 483 PHARMATHEN INTERNATIONAL S.A. - Form 483, 2017-10-26
January, 2023 FDA 483 PEL HEALTHCARE LLC - Form 483, 2023-01-13
June, 2018 FDA 483 Response Pharmaloz Manufacturing, Inc. - Form 483R, 2018-06-28
June, 2018 EIR Pharmaloz Manufacturing, Inc. - EIR, 2018-06-21
January, 2024 FDA 483 BioAnalysis, LLC - Form 483, 2024-01-26
August, 2015 FDA 483 Unimark Remedies Limited - Form 483, 2015-08-14
February, 2015 FDA 483 Central Admixture Pharmacy Services, Inc. - Form 483, 2015-02-11
December, 2017 FDA 483 Ingenus Pharmaceuticals NJ LLC - Form 483, 2017-12-14
November, 2021 EIR Micron Inc - EIR, 2021-11-05
October, 2019 FDA 483 Zydus Hospira Oncology Private Limited - Form 483, 2019-10-22
December, 2018 FDA 483 I 3 PHARMACEUTICALS, LLC - Form 483, 2018-12-21
May, 2015 FDA 483 Afton Scientific, LLC - Form 483, 2015-05-01
March, 2024 FDA 483 Alembic Pharmaceuticals Limited - Form 483, 2024-03-08
October, 2018 FDA 483 Alchymars ICM SM Private Limited - Form 483, 2018-10-19
October, 2020 EIR Pharmaceutics International, Inc. - EIR, 2020-10-30
April, 2018 EIR Altasciences CDMO Philadelphia - EIR, 2018-04-05
March, 2017 FDA 483 Sanofi-Aventis Deutschland GmbH - Form 483, 2017-03-03
February, 2018 EIR DSM Nutritional Products GmbH - EIR, 2018-02-02
April, 2019 EIR Catalent Pharma Solutions, LLC - EIR, 2019-04-16
March, 2013 FDA 483 SGS North America Inc. - Form 483, 2013-03-06
September, 2014 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2014-09-12
June, 2016 EIR Powdersize, LLC - EIR, 2016-06-17
September, 2022 FDA 483 Athenex Pharma Solutions, LLC - Form 483, 2022-09-16
January, 2015 FDA 483 Abbey Color Incorporated - Form 483, 2015-01-20
September, 2013 FDA 483 AbbVie Bioresearch Center - Form 483, 2013-09-13
May, 2015 FDA 483 Wockhardt Limited - Form 483, 2015-05-26
October, 2018 EIR Dr Reddy's Laboratories Limited - EIR, 2018-10-30
June, 2018 FDA 483 Pharmaloz Manufacturing, Inc. - Form 483, 2018-06-21
July, 2017 FDA 483 SHILPA MEDICARE LIMITED - Form 483, 2017-07-28
July, 2016 FDA 483 INDENA SPA - Form 483, 2016-07-29
November, 2023 FDA 483 Eurofins PROXY Laboratories B.V. - Form 483, 2023-11-10
February, 2024 FDA 483 Sun Pharmaceutical Medicare Limited - Form 483, 2024-02-27

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