FDA Investigator Ko U Min

Ko U Min has inspections in 3 countries as of 26 Sep 2023. Ko U Min has collaborated with a combinined 4212 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
27
Last Inspection Date:
26 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, India, Italy
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Aditi S Thakur, Alberto A Viciedo, Alice S Tsao, Alison N Stieg, Amy L Singer, Amy M Cramer, Anastasia I Offordile, Anastasia I Onuorah, Anastasia M Shields, Anita Narula, PhD, Anita R Michael, Ankur C Patel, Annemarie Bodnar, Anthony A Charity, Atul J Agrawal, Audrey Thereset Uy, Barbara A Gullick, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Bijoy Panicher, Bijoy Panicker, Brandy N Lepage, Brooke K Higgins, Brooke K Seeman, Bryan L Mcguckin, CDR Ileana Barreto Pettit, Chaltu N Wakijra, Charles Yuanchia Kuo, PhD, Chiang Syin, PhD, Chiaochun J Wang, Christina K Theodorou, Christopher R Czajka, Craig D Zagata, Crystal Monroy, Cynthia A Palmer, Daniel J Grabicki, Daniel J Lahar, Daniel J Min, David A Oluwo, Dawn L Wydner, Debra J Bennett, Debra L Pagano, Denise M Digiulio, Dennis L Doupnik, Diane T Bargo, Diane T O'brien, Dorothy J Denes, Douglas A Campbell, Douglas C Kovacs, Dr. Dominick Roselle, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Yubing Tang, Edmund F Mrak, Jr, Emest F Bizjak, Emmanuel J Ramos, Erik W Koester, Erika V Butler, Erk W Koester, Frederick Razzaghi, Gayle S Lawson, George Lunn, PhD, George Pyramides, Gloria J Baca, MS, Guerlain Ulysse, Hala L Selby, Hala Lj Whetstone, Hector J Colon Torres, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Huiquan Wu, Hung H Do, MS, Ivis Lnegron Torres, James L Dunnie, Jr, James M Mason, James M Simpson, James R Birkenstamm, Janet A Rajan, Jay B Shah, Jogy George, John P Mistler, Johnna L Bleem, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan W Chapman, Jose Acruz Gonzalez, Jose M Cayuela, Jose O Hernandez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph F Mcginnis, RPh, Joseph Mcginnis, Joseph W Matthews, Joy Rkozlowski Klena, Julianne C Mccullough, Junho Pak, Junho Park, Justine Tomasso, Karen A Briggs, Karen E D'orazio, Karishma G Gopaul, Katelyn Astaub Zamperini, Katherine Szestypalow, Kathleen M Jordan, Kelli F Dobilas, Kendra L Brooks, Kenneth Gordon, Kenneth M Gordon, Kenneth Nieves, Kevin P Foley, Kristen D Evans, Kristina L Conroy, Kshitij A Patkar, Kurt A Brorson, PhD, Lance M De Souza, MBA, Lata C Mathew, PhD, Lauren L Vajo, Lawrence Harmon, Jr, Lawrence J Stringer, Leiyun Boone, PhD, Liatte Kreuger, PharmD, Linda M Hoover, Lisa K Capron, Lisa M Bellows, Lori S Lawless, Luis A Dasta, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcus A Ray, Marea K Harmon, Margaret M Doherty, Margaret M Sands, Maria A Reed, Maria Estrella, Marijo B Kambere, PhD, Marlene G Swider, Massoud Motamed, Matthew M Henciak, Meena Bansal Gupta, PhD, Melissa J Garcia, Melissa T Roy, Meyer J Slobotsky, Michael A Taylor, Michael Gurbarg, Michael L Casner, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michele Gottshall, Michele M Falchek, Michelle Marsh, Mindy M Chou, Monika Borkowska, Nailing Zhang, Nancy F Scheraga, Nancy M Espinal, Nancy Sheraga, Nataniel Phillips Sylvain, PhD, Natasha Gupta, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul L Bellamy, Paula J Bretz, Prabhu P Raju, Pratik S Upadhyay, DDC, Qin Xu, Rabin N Ghoshal, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Rebecca E Dombrowski, Regina T Brown, Richard E Needham, Robert B Shibuya, MD, Robert D Tollefsen, Robert J Maffei, Robert J Martin, Russell J Glapion, Saleem A Akhtar, Sam Pepe, Samuel Mindaye, Sandra A Boyd, Sarah Adella Fave, Sean R Marcsisin, Sena G Dissmeyer, Sharon K Thoma, PharmD, Shirley J Berryman, Shirley S Wen, Shirshendu K Deb, PhD, Simone E Pitts, Sneha Patel, Sneha S Patel, Sony Mathews, Sridhar Thumma, Srinivas R Chennamaneni, PhD, Stephanie Mangigian, MS/OSH, RN, Stephen J Koniers, Susan F Laska, MS, Syeda N Mahazabin, Tamika White, Tamil Arasu, PhD, Tammy L Chavis, Temar Q Williams, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, Tiffani D Wilson, Todd J Maushart, Tonia F Bernard, Toyin B Oladimeji, Tracy K Li, Unnee Ranjan, Valerie L Whipp, Viviana Matta, Vivin George, Vlada Matusovsky, Walter L Fava, Wanda Y Honeyblue, Wayne E Seifert, William A Warnick, William L Bargo, Yan Wang, Yong Wu, PhD, Yvesna C Blaise, Yvins Dezan, Zachary A Bogorad, Zhihao Qiu (Peter), PhD, Zhongren Wu

Ko U Min's Documents

Publish Date Document Type Title
January, 2023 FDA 483 PEL HEALTHCARE LLC - Form 483, 2023-01-13
February, 2022 FDA 483 Guardian Drug Company - Form 483, 2022-02-17
November, 2020 FDA 483 Response Novel Laboratories, Inc. - Form 483R, 2020-11-05
November, 2017 FDA 483 Pharmaceutics International, Inc. - Form 483, 2017-11-16
August, 2020 FDA 483 ImClone Systems LLC - Form 483, 2020-08-21
June, 2021 FDA 483 Carnegie Pharmaceuticals, LLC - Form 483, 2021-06-29
November, 2020 FDA 483 Novel Laboratories, Inc. - Form 483, 2020-11-05
June, 2018 FDA 483 Advanced Accelerator Applications (Italy) S.r.l. - Form 483, 2018-06-08
March, 2022 FDA 483 SAMJAN GROUP INC. - Form 483, 2022-03-03
August, 2020 FDA 483 Response ImClone Systems LLC - Form 483R, 2020-09-14
March, 2022 FDA 483 Novel Laboratories, Inc. - Form 483, 2022-03-30
April, 2015 FDA 483 WuXi Advanced Therapies Inc. - Form 483, 2015-04-17
February, 2022 FDA 483 Response Guardian Drug Company - Form 483R, 2022-02-17
April, 2015 EIR WuXi Advanced Therapies Inc. - EIR, 2015-04-17
April, 2018 FDA 483 Response Mylan Pharmaceuticals Inc. - Form 483R, 2018-05-03
December, 2021 FDA 483 Aurolife Pharma LLC - Form 483, 2021-12-07
September, 2021 FDA 483 Paramesh Banerji Life Sciences LLC - Form 483, 2021-09-24
August, 2018 FDA 483 Akorn Operating Company LLC (dba Akorn) - Form 483, 2018-08-30
May, 2017 FDA 483 Pharmaceutical Manufacturing Research Services, Inc. - Form 483, 2017-05-25
May, 2017 EIR Pharmaceutical Manufacturing Research Services, Inc. - EIR, 2017-05-25
July, 2017 FDA 483 Bend Research Inc. - Form 483, 2017-07-21
May, 2022 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2022-06-22
May, 2022 FDA 483 Akorn Operating Company LLC (dba Akorn) - Form 483, 2022-05-17
April, 2018 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2018-04-12
February, 2022 EIR Guardian Drug Company - EIR, 2022-02-17
May, 2021 FDA 483 SAMJAN GROUP INC. - Form 483, 2021-05-28
March, 2022 FDA 483 SAMJAN GROUP INC. - Form 483, 2022-03-03

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