FDA Investigator Katherine Szestypalow

Katherine Szestypalow has inspections in 20 countries as of 25 Oct 2023. Katherine Szestypalow has collaborated with a combinined 8416 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
112
Last Inspection Date:
25 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Canada, Belgium, Spain, India, France, Switzerland, Germany, Korea (Republic of), United States of America, Japan, China, Australia, Sweden, Portugal, Mexico, United Kingdom of Great Britain and Northern Ireland, Italy, Thailand, Taiwan
Co-Investigator(s):
Adaliz Santaliz Cruz, Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Alan L Truong, Alan P Kurtzberg, Alanna Lmussawwir Bias, Alberto A Viciedo, Albinus D'sa, PhD, Albinus M D Sa, Alice S Tsao, Alicia M Mozzachio, Amanda E Lewin, PhD, Ana P Pineda Zavaleta, Anastasia G Lolas, Anastasia M Shields, Andrea A Branche, Angela E Glenn, Anissa M Vargas, Anita Narula, PhD, Ann L Demarco, Anna M Brannen, Anthony A Charity, Anthony C Warchut, Anthony J Lagreca, April L Young, Arie C Menachem, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arsen Karapetyan, Ashar P Parikh, Ashley L Reiber, Ashutosh Rao, PhD, Atul J Agrawal, Aurora Miha Trifanov, Azza Talaat, Bapu R Gaddam, Barbara D Wright, Barbara Janine Breithaupt, Barbara L Rogolsky, Bichsa T Tran, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brandy N Lepage, Brenda W Uratani, PhD, Brian D Nicholson, Brian L Belz, Bryce A Hammer, Camerson E Moore, Carl A Huffman, III, Carla J Lundi, Carol A Gripp, Caroline H Le, Carrie A Hughes, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Cheryl A Clausen, Christopher D Leach, Christopher M Jenner, Christopher T Middendorf, Chryste D Best, Claire M Minden, Cody D Rickman, Constantin Y Philopoulos, Courtney N Long, Cynthia Jim, CSO, Cynthia M Goudeau, Cynthia T Cain, Dandan Wang, PhD, Daniel J Lahar, Daniel J Roberts, Darren S Brown, Daryl A Dewoskin, David J Eide, Dawn E Barkans, Debra I Love, Demitria J Xiradakis, Dennis Cantellops Paite, Diane L Raccasi, Dina K West, Dipesh K Shah, Djamila Harouaka, Donald C Obenhuber, PhD, Dongping Dai, PhD, Douglas A Campbell, Dr. Barbara D Paul, PhD, Dr. Gang Wang, PhD, Dr. Gopa Biswas, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. S Nar Ali, PhD, Edmund F Mrak, Jr, Edwin Melendez, Eileen A Liu, Ephrem Hunde, PhD, Eric L Dong, BS, Eric M Mueller, PharmD, Erik W Koester, Erika V Butler, Erin D Mccaffery, Farhana Khan, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Frank L Cordova, Frank Wackes, Frederick L Fricke, Gam S Zamil, Gayle S Lawson, George J Flynn, Gerald B Seaborn, Jr, Geraldine D Sanders, Geraldine Sanders, Ginger M Sykes, Grace E Mcnally, Gregson A Joseph, Gwyn G Dickinson, Hala L Selby, Hamet M Toure, PharmD MPH, Haroon Vohra (NMI), Hasan A Irier, PhD, Heika R Tait, Helen Verdel, Henry E Sanchez, Herbert M Corbello, Heriberto Negron Rivera, Isabel Y Espinosa, Ismael Olvera, IV, Israel Santiago, OCM, Ivis L Negrón, Ivis Lnegron Torres, Jacqueline Mdiaz Albertini, James A Jagon, James A Liubicich, James C Maclaughlin, James I Giefer, James L Dunnie, Jr, James P Mcreavey, James R Birkenstamm, James S Cartwright, Jamie L Dion, Jared P Stevens, Jason K Morgan, Jawaid Hamid, Jeffery A Hangartner, Jennifer C Adams, Jennifer L Gustavus, Jennifer L Huntington, Jennifer L Sheehan, Jessica L Pressley, Joanne E King, Joey V Quitania, Jogy George, John A Gonzalez, John D White, Jonathan G Matrisciano, Jonathan W Chapman, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Jose R Hernandez, Joseph R Haynes, Juhong Liu, PhD, Julianne C Mccullough, Julie D Bringger, June P Page, Junho Pak, Justin A Boyd, Justin R Carr, Justine Tomasso, Karen A Wolnik, Karen G Hirshfield, Karen K Moksnes, Karen L Kosar, Karen M Cooper, Karen S Anthony, Karen Takahashi, Kari M Johansen, Kathy Szestypalau, Kejun Cheng, Kellia N Hicks, Kenneth H Williams, Kenneth V Miller, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Ko U Min, Kristen D Evans, Kristy A Zielny, Kristy E Zuroski, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laurimer Kuilan Torres, LCDR Michael H Tollon, Li Hongpaul Yeh, PhD, Liatte Kreuger, PharmD, Libia M Lugo, Lillian S Wu, Lillie D Witcher, Liming Zhang, Linda F Murphy, Linda K Cline, Linda M Cheny, Linda Thai, Lindsey M Schwierjohann, Lloyd D Payne, LT Daveta L Bailey, Lucas B Leake, Lucila B Nwatu, Luis A Dasta, Luis M Burgos Medero, M Aabel I, Mada A Tautges, Madushini Dharmasena, PhD, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Margaret M Annes, Maria Joselopez Barragan, PhD, Maria V Price, Marian E Ramirez, Marianela Aponte Cruz, Marie A Fadden, Marie F Morin, Marijo B Kambere, PhD, Mark R Mcclain, Marvin D Jones, Mary E Storch, Marybet Lopez, Massoud Motamed, Mathew T Thomas, MD, Matthew B Casale, Matthew C Watson, Matthew J Hansen, Matthew R Dionne, Melinda L Rice, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Meredith P Soehl, Investigator, Michael A Charles, Michael A Taylor, Michael C Rogers, Michael E Maselli, Michael J Kuchta, Michael Kuchta, Michael L Casner, Michael L Chasey, Michael R Goga, Michael S Smoker, Michael Shanks, MS, Michael Y Philopoulos, Michele Gottshall, Michele L Forster, PhD, Michele L Glendenning, Michele Perry Williams, Miguel A Martinez, Mihaly S Ligmond, Mindy M Chou, Minh D Phan, Monica Cburgos Garcia, Monica E Caphart, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy A Bellamy, Nancy G Schmidt, Nancy L Neiger, Nancy M Espinal, Nathan M Jornod, Nayan J Patel, Nicholas F Lyons, Nicholas L Hunt, Nicole E Knowlton, Nije A Thomas, Nikki S Ramirez, Noreen Muniz, Omotunde O Osunsanmi, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patrice S Hall, Patricia A Brown, Patricia A Cortez, Patricia Brown, Patrick C Klotzbuecher, Patrick D Stone, MS, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paula R Katz, Peter C Chow, Peter E Baker, Pratik S Upadhyay, DDC, Qin Xu, Rachael L Cook, Rafael Nevarez Nieves, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramon A Hernandez, Randy L Self, Raymond T Oji, Reba A Gates, Rebecca E Dombrowski, Rebecca H Lee, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Rhoda B Eniafe, Richard J Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richmond K Yip, Ricki A Chase, Ricki Achase Off, Rita K Kabaso, Robert C Coleman, Robert C Henry, Robert C Steyert, Robert D Tollefsen, Robert J Doyle, Robert J Martin, Robert L Lewis, Jr, Robert M Barbosa, Robert Rodriguez, Robert Sharpnack, Rochelle K Kimmel, Rochelle L Cross, Roger F Zabinski, Ronald G Crawford, Ronda R Loyd Jones, Rose M Ashley, Rose Xu, Rumany C Penn, PharmD, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Sam Pepe, Samantha J Bradley, Samantha J Pinizzotto, D V M, Samuel T Walker, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah E Mcmullen, Sarah Ibrahim, Satheesh Thomas, Scott B Laufenberg, Scott R Nichols, PhD, Scott T Ballard, Seifert Seifert, Wayne E, Seneca D Toms, Sharon K Thoma, PharmD, Shelby N Marler, Sherry G Bous, Shirley J Berryman, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sneha S Patel, Sony Mathews, Sripal R Mada, PhD, Stacie A Woods, Stephen D Brown, Stephen D Eich, Stephen J Kilker, Stephen J Koniers, Steven A Gonzales, Steven C Madzo, Steven Fong, MS, PhD, Steven Frisbee, Steven M Weinman, Steven P Donald, Sue Lee Chan, Susan L Young, Susan M Jackson, Susan P Bruederle, Susan W Ting, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Syed N Ali, Taichun Qin, PhD, Tajah L Blackburn, Tamala P Magee, Tamil Arasu, PhD, Tenzin Jangchup, Terri L Dodds, Thai T Duong, Theressa B Smith, Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tina M Pawlowski, Tonya R Johnson, Torrance J Slayton, Tracey L Harris, Tracy K Li, Truong Xuan Nguyen (Andy), Tsedenia Woldehanna, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Valerie L Whipp, Valshall Patel, Verlinda A Narcisse, Vickie J Kanion, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Vivin George, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wayne T Smith, Wenzheng Zhang, William A Warnick, William Hallett, PhD, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Xiomara Copeland, Yaodong Huang, Ying Xin Fan, PhD, Yiying E Chen, Young M Choi, PhD, Yumi J Hiramine, Yvette I Johnson, Yvins Dezan, Zabinski Zabinski, Roger F, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhaoyang Meng, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu, Zi Qiang Gu

Katherine Szestypalow's Documents

Publish Date Document Type Title
October, 2002 FDA 483 Response Sichuan Long March Pharmaceutical Co. Ltd. - Form 483R, 2002-11-20
July, 2003 FDA 483 BioVectra Inc - Form 483, 2003-07-14
March, 2001 EIR Mylan Pharmaceuticals ULC - EIR, 2001-05-24
January, 2004 EIR SINTENOVO SA DE CV - EIR, 2004-03-26
January, 2004 EIR Sicor de Mexico S.A. de C.V. - EIR, 2004-03-26
January, 2004 FDA 483 Sicor de Mexico S.A. de C.V. - Form 483, 2004-01-22
July, 2003 EIR Biotrial Bioanalytical Service - EIR, 2003-07-18
October, 2002 FDA 483 Shanghai Medicinal Ltd. No. 15 Pharm Fact. - Form 483, 2002-10-17
July, 2003 FDA 483 Response BioVectra Inc - Form 483R, 2003-08-05
March, 2007 EIR Apitoria Pharma Private Limited - EIR, 2007-05-17
March, 2001 FDA 483 Response Mylan Pharmaceuticals ULC - Form 483R, 2001-03-09
June, 2002 FDA 483 Merck Lipha S.A.S. Centre de Production de Meyzieu - Form 483, 2002-06-11
June, 2015 FDA 483 ION EXCHANGE INDIA LIMITED - Form 483, 2015-06-26
December, 2004 FDA 483 Sandoz Incorporated - Form 483, 2004-12-09
December, 2000 FDA 483 Upsher-Smith Laboratories, LLC - Form 483, 2000-12-19
March, 2003 FDA 483 Response UCB Pharma S.A. - Form 483R, 2003-04-28
March, 2002 FDA 483 MedMira Laboratories Inc. - Form 483, 2002-03-27
October, 2002 EIR Sichuan Long March Pharmaceutical Co. Ltd. - EIR, 2002-10-25
October, 2002 FDA 483 Response Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - Form 483R, 2002-12-09
September, 2014 FDA 483 Response Zydus Lifesciences Limited - Form 483R, 2014-09-26
August, 2013 FDA 483 Apotex Inc. - Form 483, 2013-08-30
August, 2013 FDA 483 Apotex Inc. - Form 483, 2013-08-20
July, 2009 FDA 483 Cody Laboratories, Inc. - Form 483, 2009-07-24
March, 2003 EIR UCB Pharma S.A. - EIR, 2003-03-28
September, 2014 FDA 483 Zydus Lifesciences Limited - Form 483, 2014-09-05
October, 2003 FDA 483 Unique Chemicals - Form 483, 2003-10-29
July, 2003 EIR Questcor Pharmaceuticals, Inc - EIR, 2003-07-14
February, 2008 FDA 483 Daito Pharmaceutical Co., Ltd - Form 483, 2008-02-25
April, 2013 EIR Lonza AG - EIR, 2013-04-12
October, 2002 FDA 483 Changzhou Pharmaceutical Factory - Form 483, 2002-10-31
April, 2006 FDA 483 Zhejiang Hisun Pharmaceutical Co., Ltd. - Form 483, 2006-04-20
July, 2003 FDA 483 Ethypharm, Inc. - Form 483, 2003-07-24
October, 2002 FDA 483 Response Changzhou Pharmaceutical Factory - Form 483R, 2002-12-30
August, 2014 FDA 483 Strides Pharma Science Limited - Form 483, 2014-08-26
January, 2004 FDA 483 SINTENOVO SA DE CV - Form 483, 2004-01-26
October, 2009 EIR Adare Pharmaceuticals Srl - EIR, 2009-10-09
June, 2012 EIR Lonza Braine S.A. - EIR, 2012-06-14
October, 2002 EIR Changzhou Pharmaceutical Factory - EIR, 2002-10-31
October, 2002 FDA 483 Sichuan Long March Pharmaceutical Co. Ltd. - Form 483, 2002-10-25
May, 2017 FDA 483 Hainan Shuangcheng Pharmaceuticals Co., Ltd. - Form 483, 2017-05-26
June, 2002 FDA 483 Merck Sante SAS - Form 483, 2002-06-18
March, 2003 FDA 483 UCB Pharma S.A. - Form 483, 2003-03-28
October, 2002 EIR Shanghai Medicinal Ltd. No. 15 Pharmaceutical Factory - EIR, 2002-10-17
April, 2006 EIR Zhejiang Hisun Pharmaceutical Co., Ltd. - EIR, 2006-04-20
October, 2009 FDA 483 Adare Pharmaceuticals Srl - Form 483, 2009-10-09
January, 2004 FDA 483 Response SINTENOVO SA DE CV - Form 483R, 2004-02-24
March, 2003 EIR Pfizer Inc. - EIR, 2003-03-17
July, 2003 FDA 483 Response Biotrial Bioanalytical Service - Form 483R, 2003-11-05
July, 2003 EIR BioVectra Inc - EIR, 2003-07-14

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