FDA Investigator Karen M Cooper

Karen M Cooper has inspections in 22 countries as of 24 Oct 2023. Karen M Cooper has collaborated with a combinined 5481 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
437
Last Inspection Date:
24 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Fiji, United Kingdom of Great Britain and Northern Ireland, Canada, Netherlands, Peru, Switzerland, Italy, France, Denmark, Chile, South Africa, Panama, Romania, Costa Rica, Dominican Republic, Brazil, Czechia, Germany, Ecuador, Belize
Co-Investigator(s):
Alan Escalona, Alec M O'neal, Alexander M Kay, Allison C Hunter, Allison M Scheck, Amanda E Lewin, PhD, Amanda M Osteen, Ana P Barido, Andrea D Swingle, Andrew I Carr, Andrew M Kupper, Andrew T Todd, Andria L Kuhlman, Anetra E Wyatt, Anna M Brannen, Annemarie Kleiza, Anthony J Grace, Arie R Dyk, Arindam Dasgupta, PhD, Ashley M Whitehurst, Aurora Miha Trifanov, Bailey A Uetrecht, Barbara A Rusin, Barbara D Wright, Barbara M Frazier, Benjamin D Shuler, Betsy C Galliher, Bonita S Chester, Brandon L Mariner, Brenda C Hamilton, Brenda W Uratani, PhD, Brian J Ryan, Brian P Hendrickson, Brian R Yaun, Brittany M Lowe, Bruce, Brunilda Torres, Bryan J Love, Caitlin L Almonrode, Camerson E Moore, Cara M Minelli, Carla J Lundi, Carol Mrivera Lopez, PhD, Carrie L Doupnik, Cassandra L Winters, Charanjeet Jassal, Charisse K Green, Charles D Boison, Christian L Witkovskie, Christine E Kelley, Christopher J Adams, Christopher T Middendorf, Clinton D Priestley, Cody D Rickman, Comyar Shoghi, Cooper Cooper, Karen M, Craig A Garmendia, Craig P Seaborn, Craig T Rybus, Cynthia A Harris, MD, RN, Cynthia F Kleppinger, MD, Cynthia L Rakestraw, D'arbra R Blankenship, David C Radle, David L Chon, David P Moorhead, David R Heiar, Dawn C Olenjack, Deborah A Greco, Debra L Boyd Seale, Dell S Moller, Denise L Burosh, Diane Cvan Leeuwen, Diane L Raccasi, Diane R Mcdaniel, Diane T Reindl, Dianiris C Ayala, Donna D Gallien, MPH, Donna F Campbell, Doretha M Tonkins, Downer, Dr. Sriram Subramaniam, PhD, Dylin Yao, Eileen A Liu, Eileen T Monaghan, Elizabeth Ll Edwards, Elizabeth P Kinsella, Emily E Krumel, Eric R Holm, Eric S Myskowski, Ethan P Stegman, Fabian Nchaparro Rodriguez, Felipe Rde Almeida, Gail L Katz, Geoffrey K Kilili, George C Amedro, Gerald Mierle, Gilbert J Heidenblut, Glenn S Quintanilla, Green, Gretchen N Kilby, Harmon M Blanch, Hasan A Irier, PhD, Helen B Ricalde, Holly J Rapier, Holly J Wilson, Hugh M Mcclure, II, Ifueko Osemwota, Iram R Hassan, PhD, Israel Santiago, OCM, James A Jagon, James G Marsh, James P Mcevoy, James R Fleckenstein, Jamie L Johnson, Janet L Bowen, Jason D Werne, Javonica F Penn, Javonica Penn, Jean Brewer, Jennifer A Bazergui, Jennifer L Jager, Jennifer L Sheehan, Jennifer M Heitz, Jessica M Wooten, Joanne E King, Jocelyn C Turner, Joel D Martinez, John A Kadavil, PhD, John B Crowe, John D Jaworski, John E Russell, Jonathan A Ferguson, Jonathan D Horn, Jonathan R Campos, Jose Acruz Gonzalez, Joseph A Dinardo, Joseph T Dougherty, Joseph T Frost, Joseph W Matthews, Joseph X Kaufman, Joshua P Wireman, Joshua S Hunt, Judith A Jankowski, Julie Scoma, Karen L Kosar, Karen M Bryerton, Karen M Kondas, Katherine Szestypalow, Kathleen D Culver, Kathryn J Mccarty, Kathryn Sulting, Kathryn Suttling, Keith J Mason, Kelli Wilkinson, Kenneth L Smalls, Kerry Ann Latham, Kilili Kilili, Geoffrey K, Kimberly A Benson, Kirk A Dymbrowski, Klein, Krista T Ferry, Kristy A Zielny, La Tasha M Gunter, Lakecha N Lewis, Laressa R Gray, Larry K Austin, Laura E Garcia, Lauren R Collins, Laurie P Norwood, Laurissa S Flowers, Lawrence Y Lee, PhD, LCDR Angelica M Chica, Leah M Andrews, Leena Thomas, Leigh Anne Myers, Lequita M Mayhew, Lewis K Antwi, Li Hongpaul Yeh, PhD, Linda M Cheny, Linda R Kuchenthal, Linda S Mattingly, Lindsey M Schwierjohann, Lisa M Thursam, Lisa P Oakes, Lori A Carr, Lori S Lawless, LT Richard A Lyght, Luckner Jean Marie, Luis M Burgos Medero, Luz I Collado, M Patriciaurphy Murphy, Maney P Sturgill, Marcia A Worley, Margaret M Annes, Margaret Torres Vazquez, Marianne Allen, Maribeth G Niesen, Marion W Nadeau, Mark E Parmon, Mark R Mcclain, Martha S Baldwin, Martin K Yau, PhD, Mary B Sheets, Matt D Suedkamp, Matthew C Watson, Matthew F Duff, Maureen F Alleman, Melkamu Getie Kebtie, PhD, Michael Campbell, Michael E Campbell, Michael E Clark, Michael J Schibi, Michael K Larson, Michael P Anthony, Michael P Sheehan, Michael Serrano, Michelle L Jones, Michelle M Noe Varga, Mishelle L Harriger, Mohsen Rajabi Abhari, FDA, Mpris Inspector, Myla D Chapman, Nadeem I Chaudhry, Nancy A Bellamy, Nancy L Meade, Nancy L Neiger, Nicholas F Lyons, Nicholas L Paulin, Nicholas Paulin, Nicola M Fenty Stewart, Nicole M Bell, Nisha C Patel, Pamela A Kuist, Patricia A Borrusso, Patricia A Homola, Patricia A Morrow, Paul A Bonneau, Paul M Chefor, Paula M Laplant, Payne, Peter M Trunk, Pifer, Raquel L Coleman, Richard W Berning, Robert E Hultman, Robert Rodriguez, Robert W Hudson, Rosanna M Goodrich, Roy C Stephens, Russell K Riley, Samantha J Pinizzotto, D V M, Sarah M Parkinson, Seongeun Cho (Julia), PhD, Sereen Gmorgan Murray, Shannon A Gregory, Sharon K Thoma, PharmD, Shavon L Square, Shelley H Beausoleil, Shirhonda D Thorn, Shirley S Wen, Shusheen A Alexander, Sripal R Mada, PhD, Stanley Au, State Agency, Stephanie L Shapley, Stephen J Kilker, Stephen J Rabe, Steven M Weinman, Susan D Yuscius, Susan M Taylor, Takiyah S Gilmore Embery, Talmane J Fisher, Tamara M Kays, Tania E Vizcaino, Tanya E Malais, Teddy Tom, Thomas B Smith, Thomas C Woods, Thomas E Friel, Thomas J Hudson, Thomas J Prigge, Thomas O Morgan, Thomas S Donaldson, Thomas W Nojek, Thunder N Dunkijacobs, Tracey L Harris, Traci C Kelm, Troy A Huffman, Truong Xuan Nguyen (Andy), Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Victor Spanioli, Wanda Y Honeyblue, William D Bassett, Jr, William G Nelson, William K Ducloux, William W Dotts, Xikui Chen (nmi), PhD, Yangmin Ning, Yehualashet A Gessesse, Yiying E Chen, Yumi J Hiramine, Yvette Mlacour Davis

Karen M Cooper's Documents

Publish Date Document Type Title
March, 2003 EIR Image Analysis Inc - EIR, 2003-03-05
July, 2014 EIR Brenda L Wong MD - EIR, 2014-07-02
January, 2010 FDA 483 Ephraim McDowell Health IRB - Form 483, 2010-01-06
January, 2012 EIR Our Lady Of Bellefonte Hosp IRB - EIR, 2012-01-06
July, 2019 FDA 483 Wendy C. Daly, M.D. - Form 483, 2019-07-01
August, 2019 FDA 483 Pablo H. Vivas, M.D. - Form 483, 2019-08-22
April, 2018 FDA 483 Steven Ciciora, M.D. - Form 483, 2018-04-05
March, 2003 FDA 483 Response Image Analysis Inc - Form 483R, 2003-09-10
January, 2017 EIR Davis Remington Inc - EIR, 2017-01-27
October, 2020 EIR Charles River Laboratories Inc - EIR, 2023-10-17
January, 2021 FDA 483 Chandler H. Park, MD - Form 483, 2021-01-15
August, 2004 FDA 483 Bardstown Mill Inc - Form 483, 2004-08-23
February, 2018 FDA 483 Dan L. Stewart, M.D. - Form 483, 2018-02-12
April, 2014 EIR James L. Borders, MD - EIR, 2014-04-04
August, 2019 EIR Pablo H. Vivas, M.D. - EIR, 2019-08-22
September, 2015 FDA 483 OPKO Health, Inc. - Form 483, 2015-09-30
May, 2012 EIR Novo Nordisk A/S - EIR, 2012-05-03
August, 2009 FDA 483 NIH Clinical Center - Form 483, 2009-08-21
March, 2003 FDA 483 Image Analysis Inc - Form 483, 2003-03-05
August, 2019 FDA 483 Andrew R. Gould, M.D. - Form 483, 2019-08-08
February, 2013 EIR NALMA, S.A. - EIR, 2013-02-01
August, 2021 FDA 483 Jennifer L. Miller, M.D. - Form 483, 2021-08-19
April, 2014 FDA 483 James L. Borders, MD - Form 483, 2014-04-04
April, 2019 FDA 483 Lyle Myers, M.D. - Form 483, 2019-04-23
January, 2017 FDA 483 Davis Remington Inc - Form 483, 2017-01-27
November, 2010 FDA 483 Kentucky Blood Center Inc - Form 483, 2010-11-05
September, 2015 FDA 483 Response OPKO Health, Inc. - Form 483R, 2015-10-07
January, 2010 EIR Ephraim McDowell Health IRB - EIR, 2010-01-06
January, 2012 FDA 483 Our Lady Of Bellefonte Hosp IRB - Form 483, 2012-01-06
April, 2014 FDA 483 Response James L. Borders, MD - Form 483R, 2014-04-18
August, 2018 EIR Charles River Laboratories Ashland, LLC - EIR, 2018-08-03
November, 2019 FDA 483 University of Kentucky - Form 483, 2019-11-21
November, 2014 EIR Kevin Song, MD - EIR, 2014-11-21
June, 2013 EIR Amazon.com KYDC, LLC - EIR, 2013-06-11
September, 2015 EIR OPKO Health, Inc. - EIR, 2015-09-30
March, 2011 FDA 483 Ephraim McDowell Health IRB - Form 483, 2011-03-02
January, 2012 FDA 483 Response Our Lady Of Bellefonte Hosp IRB - Form 483R, 2012-01-20
September, 2022 EIR Angela L. Genge, M.D. - EIR, 2022-10-04

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