FDA Investigator Karen M Cooper

Karen M Cooper has conducted inspections on 437 sites in 21 countries as of 05 Dec 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
437
Last Inspection Date:
05 Dec 2022
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Italy, United States of America, Costa Rica, Peru, Ecuador, Fiji, Canada, Denmark, Romania, Panama, United Kingdom of Great Britain and Northern Ireland, Switzerland, Brazil, Czechia, Dominican Republic, Netherlands, Belize, Germany, South Africa, France, Chile
FDA Investigators that have inspected at least one site in common with Karen M Cooper:
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, Anastasia I Onuorah, 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, Brunilda Torres, Bryan J Love, Caitlin L Almonrode, Camerson E Moore, Cara M Minelli, Carla J Lundi, Carol Rivera 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, Craig A Garmendia, Craig P Seaborn, Craig Rybus, 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, David W Mason, Dawn C Olenjack, Deborah A Greco, Debra Lboyd Seale, Dell S Moller, Denise L Burosh, Dennis R Downer, 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, Dr. Sriram Subramaniam, PhD, Dylan D Yao, MD, PhD, Eileen A Liu, Eileen T Monaghan, Elizabeth Ll Edwards, Elizabeth P Kinsella, Emily A Baldwin, Emily E Krumel, Eric R Holm, Eric S Myskowski, Ethan P Stegman, Fabian Nchaparro Rodriguez, Felipe Rde Almeida, Gail L Katz, Gene R Gunn, Geoffrey K Kilili, George C Amedro, Gerald Mierle, Gilbert J Heidenblut, Glenn S Quintanilla, 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, 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, Jr, 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, Josiah D Davis, Judith A Jankowski, Julie Scoma, Karen L Kosar, Karen M Bryerton, Karen M Kondas, Katherine Szestypalow, Kathleen D Culver, Kathryn J Mccarty, Kathryn Suttling, Keith J Mason, Jr, Kelli L Wilkinson, Kellie R Riggs, Kelsey L Vansickle, Kenneth L Smalls, Kerry Ann Latham, Kibily D Dembele, Kilili Kilili, Geoffrey K, Kimberly A Benson, Kirk A Dymbrowski, Krista T Ferry, Kristy A Zielny, La Tasham 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 Mburgos Medero, Luz I Collado, Maney P Sturgill, Marcia A Worley, Margaret M Annes, Margaret Torres Vazquez, Marianne Allen, Maribeth G Niesen, Marion W Nadeau, Marissa R Stough, Mark E Parmon, Mark R Mcclain, Martha S Baldwin, Martin K Yau, PhD, Mary B Sheets, Matt D Suedkamp, Matthew B Casale, Matthew C Watson, Matthew F Duff, Matthew H Pitts, Matthew J Zagula, Maureen F Alleman, Megan T Wright, Melkamu Getie Kebtie, PhD, 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, Min Lu, Mishelle L Harriger, Mohsen Rajabi Abhari, FDA, Myla D Chapman, Nadeem I Chaudhry, Nancy A Bellamy, Nancy L Meade, Nancy L Neiger, Nathan Keith, 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, 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
August, 2018 EIR Charles River Laboratories Ashland, LLC - EIR, 2018-08-03
May, 2012 EIR Novo Nordisk A/S - EIR, 2012-05-03
April, 2014 FDA 483 Response James L. Borders, MD - Form 483R, 2014-04-18
February, 2013 EIR NALMA, S.A. - EIR, 2013-02-01
August, 2021 FDA 483 Jennifer L. Miller, M.D. - Form 483, 2021-08-19
September, 2015 FDA 483 Response OPKO Health, Inc. - Form 483R, 2015-10-07
April, 2014 FDA 483 James L. Borders, MD - Form 483, 2014-04-04
September, 2015 EIR OPKO Health, Inc. - EIR, 2015-09-30
January, 2012 EIR Our Lady Of Bellefonte Hosp IRB - EIR, 2012-01-06
March, 2003 FDA 483 Image Analysis Inc - Form 483, 2003-03-05
March, 2003 EIR Image Analysis Inc - EIR, 2003-03-05
August, 2019 EIR Pablo H. Vivas, M.D. - EIR, 2019-08-22
April, 2014 EIR James L. Borders, MD - EIR, 2014-04-04
February, 2018 FDA 483 Dan L. Stewart, M.D. - Form 483, 2018-02-12
August, 2004 FDA 483 Bardstown Mill Inc - Form 483, 2004-08-23
August, 2009 FDA 483 NIH Clinical Center - Form 483, 2009-08-21
August, 2019 FDA 483 Andrew R. Gould, M.D. - Form 483, 2019-08-08
September, 2022 EIR Angela L. Genge, M.D. - EIR, 2023-11-28
January, 2017 FDA 483 Davis Remington Inc - Form 483, 2017-01-27
July, 2014 EIR Brenda L Wong MD - EIR, 2014-07-02
January, 2010 FDA 483 Ephraim McDowell Health IRB - Form 483, 2010-01-06
September, 2015 FDA 483 OPKO Health, Inc. - Form 483, 2015-09-30
January, 2012 FDA 483 Our Lady Of Bellefonte Hosp IRB - Form 483, 2012-01-06
August, 2019 FDA 483 Pablo H. Vivas, M.D. - Form 483, 2019-08-22
November, 2019 FDA 483 University of Kentucky - Form 483, 2019-11-21
March, 2003 FDA 483 Response Image Analysis Inc - Form 483R, 2003-09-10
October, 2020 EIR Charles River Laboratories Inc - EIR, 2023-10-17
November, 2010 FDA 483 Kentucky Blood Center Inc - Form 483, 2010-11-05
April, 2019 FDA 483 Lyle Myers, M.D. - Form 483, 2019-04-23
January, 2012 FDA 483 Response Our Lady Of Bellefonte Hosp IRB - Form 483R, 2012-01-20
July, 2019 FDA 483 Wendy C. Daly, M.D. - Form 483, 2019-07-01
January, 2017 EIR Davis Remington Inc - EIR, 2017-01-27
July, 2019 FDA 483 SCOTT HEALTH SERVICES, LLC - Form 483, 2019-07-23
March, 2011 FDA 483 Ephraim McDowell Health IRB - Form 483, 2011-03-02
April, 2018 FDA 483 Steven Ciciora, M.D. - Form 483, 2018-04-05
January, 2021 FDA 483 Chandler H. Park, MD - Form 483, 2021-01-15
November, 2014 EIR Kevin Song, MD - EIR, 2014-11-21
June, 2013 EIR Amazon.com KYDC, LLC - EIR, 2013-06-11
January, 2010 EIR Ephraim McDowell Health IRB - EIR, 2010-01-06

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