FDA Investigator Karen M Kondas

Karen M Kondas has inspections in 2 countries as of 05 Oct 2023. Karen M Kondas has collaborated with a combinined 2755 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:

329

Last Inspection Date:

05 Oct 2023

Investigator Role:

FDA Investigator

Redica ID:

100002881

Country:

United States of America, Canada

Co-Investigator(s):

Aaron J Fox, Allen F Hall, Allison E Sincek, Amy L Mccarthy, Andrew J Barrowcliff, Andrew J Lang, Andria L Kuhlman, Angela E Glenn, Annemarie H Cochran, Annemarie Kleiza, Barbara G Peoples, Barbara M Frazier, Benjamin J Dastoli, Benjamin P Stewart, Brian D Rogers, Brittany M Kershaw, Brunilda Torres, Bryce A Hammer, Carl J Montgomery, Carol Mrivera Lopez, PhD, Cassandra L Winters, Charles C Conn, III, Charles Cconn Lii, Chiaochun J Wang, Christina D Mello, Christine M Smith, Christopher D Snyder, Christopher T Middendorf, Clinton D Priestley, Craig T Rybus, Cynthia L Rakestraw, D'arbra R Blankenship, Daniel J Mechenbier, Darla J Christopher, Darren S Morgan, Deborah M Trout, Dell S Moller, Denise D Dion, Diane M Fresch, Djamila Harouaka, Donna D Gallien, MPH, Dorathy M Eischen, Dr. Abhijit Raha, PhD, Dr. Gopa Biswas, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Edward R Kay, Elizabeth Ll Edwards, Emilie E Kahn, Erica L Nicoll, Frederick K Lochner, Frederick M Fochner, Frederick M Lochner, Gayle S Lawson, Geoffrey K Kilili, Hugh M Mcclure, II, Iris C Macinnes, Jacqueline A O'shaughnessy, PhD, James E Frye, James R Evans, Janet L Bowen, Janet L Brown, Jazmine N Still, Jeffrey A Sincek, Jennifer A Pruden, Jennifer Alongie Vollom, Jennifer L Gustavus, Jennifer L Jager, Jennifer L Sheehan, Jennifer M Heitz, Joel D Martinez, John A Kadavil, PhD, Joshua P Wireman, Joshua S Hunt, Julie D Bringger, Karen M Cooper, Karen M Kandas, Karen M Kurudes, Kathleen D Culver, Kathryn J Mccarty, Kathryn Suttling, Kelli Wilkinson, Kent A Conforti, Klein, Larry K Austin, Laureen M Geniusz, Lauren N Howard, Lauren N Smith, Li Hongpaul Yeh, PhD, Lisa L Flores, Marcia A Worley, Margaret M Annes, Mark E Parmon, Martin K Yau, PhD, Mary E Storch, Matthew B Casale, Matthew H Pitts, Melkamu Getie Kebtie, PhD, Michael E Clark, Michael I Gorman, Michael J Schibi, Michael P Sheehan, Mishelle L Harriger, Nancy L Neiger, Nibin Varghese, MS, Nicholas L Paulin, Nicola M Fenty Stewart, Nilufer M Tampal, PhD, Nisha C Patel, Paul A Bonneau, Paul E Stein, Paula A Trost, Paula M Laplant, Philip M Panticos, Phillip M Pontikos, Pifer, Ralph A Erickson, Regina T Brown, Richard W Berning, Robert C Steyert, Robert W Jennings, Rose M Ashley, Shankar L Saha, Shannon F Underwood, Sneha S Patel, Sripal R Mada, PhD, State Agency, Stephen J Kilker, Stephen J Rabe, Stephen K Kilker, Susan D Yuscius, Susanne M Richardson, MSc RAC ELS, Tamara M Kays, Ted L Anderson, Thomas J Arista, Thomas S Arista, Thomas W Nojek, Thunder N Dunkijacobs, Travis M Beard, Travis R Hunt, Tyra S Wisecup, Ucheabuchi C Chudi Nwankwor, Vipulchandra N Dholakia, Wen Ning Chan (Sally), Yiyue Zhang (nmi), PhD, Yvette Mlacour Davis, Zhigang Sun, PhD

Karen M Kondas's Documents

Publish Date	Document Type	Title
January, 2005	EIR	Sanjay S Yadav MD - EIR, 2005-01-18
August, 2009	FDA 483	Frontage Laboratories, Inc. - Form 483, 2009-08-14
May, 2002	FDA 483	Ben Venue Laboratories Inc. - Form 483, 2002-05-24
January, 2000	EIR	James C Prueter DVM - EIR, 2000-01-11
October, 2001	EIR	Douglas L Seidner MD - EIR, 2001-10-03
August, 2009	EIR	Frontage Laboratories, Inc. - EIR, 2009-08-14
March, 2013	EIR	Charles River Laboratories Ashland, LLC - EIR, 2013-03-21
November, 2000	EIR	Gliatech Inc - EIR, 2000-11-16
December, 2003	FDA 483	Case Western Reserve University - Form 483, 2003-12-09
January, 2010	FDA 483	Frontage Laboratories, Inc. - Form 483, 2010-01-14
April, 2001	FDA 483	O.E. Meyer Co. - Form 483, 2001-04-27
January, 2010	EIR	Frontage Laboratories, Inc. - EIR, 2010-01-14
November, 2001	EIR	GC Medical Equipment, Inc. - EIR, 2001-11-20
May, 2016	EIR	Charles River Laboratories Cleveland, Inc. - EIR, 2016-05-06
November, 2012	FDA 483	Western Reserve Health Education IRB - Form 483, 2012-11-09
December, 2008	FDA 483	Summa Health System IRB - Form 483, 2008-12-15
April, 2014	FDA 483	Jeffrey L. Blumer Ph.D MD - Form 483, 2014-04-29
September, 2002	FDA 483	Joseph R Calabrese MD - Form 483, 2002-09-27
November, 2015	FDA 483	Isam A. Diab MD - Form 483, 2015-11-24
March, 2014	FDA 483	Margaret E Rhee MD - Form 483, 2014-03-06
January, 2014	FDA 483	Shelly D Senders MD - Form 483, 2014-01-23
August, 2000	FDA 483 Response	Gliatech Inc - Form 483R, 2000-09-14
January, 2013	EIR	Biomat USA Inc - EIR, 2013-01-31
May, 2013	FDA 483	Elias I. Traboulsi MD - Form 483, 2013-05-15
May, 2002	FDA 483 Response	Ben Venue Laboratories Inc. - Form 483R, 2002-06-06
December, 2011	FDA 483	University Hospitals Cleveland Medical Center IRB - Form 483, 2011-12-06
September, 2009	FDA 483	Frontage Laboratories, Inc. - Form 483, 2009-09-09
August, 2003	FDA 483	Ondeo Nalco Co - Form 483, 2003-08-22
November, 2001	FDA 483 Response	Suyu Shu PhD - Form 483R, 2002-04-04
August, 2001	EIR	Richard G Barr MD PhD - EIR, 2001-08-27
May, 2001	FDA 483	Roxane Laboratories, Inc - Form 483, 2001-05-31
May, 2011	FDA 483	Mercy Health Youngstown, LLC IRB# 1 - Form 483, 2011-05-03
May, 2013	EIR	Elias I. Traboulsi MD - EIR, 2013-05-15
March, 2014	EIR	Margaret E Rhee MD - EIR, 2014-03-06
November, 2001	EIR	Suyu Shu PhD - EIR, 2001-11-13
December, 2001	EIR	Linde Gas & Equipment Inc. - EIR, 2001-12-17
January, 2013	FDA 483	Biomat USA Inc - Form 483, 2013-01-31
January, 2014	EIR	Shelly D Senders MD - EIR, 2014-01-23
May, 2001	FDA 483 Response	West-Ward Columbus Inc. - Form 483R, 2001-08-02
July, 2012	FDA 483	Shelly D Senders MD - Form 483, 2012-07-17
September, 2009	FDA 483 Response	Frontage Laboratories, Inc. - Form 483R, 2009-09-30
April, 2012	FDA 483 Response	Frontage Laboratories, Inc. - Form 483R, 2012-05-04
July, 2013	EIR	Mark Woyshville, M.D. - EIR, 2013-07-11
April, 2009	FDA 483	Natural Essentials, Inc. - Form 483, 2009-04-28
April, 2012	FDA 483	Frontage Laboratories, Inc. - Form 483, 2012-04-20
January, 2011	EIR	Cleveland Clinic - EIR, 2011-01-14
October, 2008	EIR	GOJO Industries, Inc - EIR, 2008-10-24
January, 2009	EIR	VA Northeast Ohio Healthcare System IRB - EIR, 2009-01-16
January, 2002	EIR	GOJO Industries, Inc - EIR, 2002-01-18
October, 2009	FDA 483	Biovail Contract Research - Form 483, 2009-10-30
September, 2009	EIR	Frontage Laboratories, Inc. - EIR, 2009-09-09
January, 2013	EIR	Shishuka Malhotra MD - EIR, 2013-01-14
October, 2001	FDA 483	Donald E Hricik MD - Form 483, 2001-10-23
July, 2013	FDA 483	Mark Woyshville, M.D. - Form 483, 2013-07-11
May, 2007	FDA 483	Saroj Brar MD - Form 483, 2007-05-18
August, 2001	FDA 483	Richard G Barr MD PhD - Form 483, 2001-08-27
January, 2005	FDA 483	Sanjay S Yadav MD - Form 483, 2005-01-18
November, 2001	FDA 483	GC Medical Equipment, Inc. - Form 483, 2001-11-20
June, 2013	FDA 483	Charles River Laboratories Cleveland, Inc. - Form 483, 2013-06-18
June, 2010	EIR	Frontage Laboratories, Inc. - EIR, 2010-06-18
May, 2016	FDA 483	Charles River Laboratories Cleveland, Inc. - Form 483, 2016-05-06
February, 2002	FDA 483	Carested Inc - Form 483, 2002-02-12
October, 2014	EIR	Summa Health System IRB - EIR, 2014-10-31
April, 2012	EIR	Frontage Laboratories, Inc. - EIR, 2012-04-20
February, 2000	EIR	Edward Westbrook MD - EIR, 2000-02-29
July, 2010	EIR	Charles River Laboratories Cleveland, Inc. - EIR, 2010-07-16
January, 2005	FDA 483 Response	Sanjay S Yadav MD - Form 483R, 2005-02-25
July, 2010	FDA 483	Charles River Laboratories Cleveland, Inc. - Form 483, 2010-07-16
May, 2002	EIR	Ben Venue Laboratories Inc. - EIR, 2002-05-24
November, 2001	FDA 483	Suyu Shu PhD - Form 483, 2001-11-13
June, 2015	EIR	Charles River Laboratories Montreal ULC - EIR, 2015-06-12
March, 2009	FDA 483	Abrams Eye Center Inc - Form 483, 2009-03-31
March, 2013	FDA 483	Charles River Laboratories Ashland, LLC - Form 483, 2013-03-21
August, 2012	EIR	Cleveland Clinic - EIR, 2012-08-15
May, 2007	EIR	Saroj Brar MD - EIR, 2007-05-18
September, 2002	EIR	Joseph R Calabrese MD - EIR, 2002-09-27
June, 2001	FDA 483	Global Lab Inc - Form 483, 2001-06-20
October, 2010	EIR	Shishuka Malhotra MD - EIR, 2010-10-14
July, 2001	EIR	Airgas Usa, LLC - EIR, 2001-07-19
June, 2013	EIR	Charles River Laboratories Cleveland, Inc. - EIR, 2013-06-18
January, 2010	FDA 483 Response	Frontage Laboratories, Inc. - Form 483R, 2010-01-29
February, 2012	EIR	Frontage Laboratories, Inc. - EIR, 2012-02-16
January, 2015	EIR	Nashat Y Gabrail MD - EIR, 2015-01-21
August, 2016	EIR	Deren Huang MD PhD - EIR, 2016-08-04
December, 2004	FDA 483	Albright Welding Supply Co., Inc. - Form 483, 2004-12-09
May, 2010	FDA 483	Vitalant - Form 483, 2010-05-11
August, 2016	FDA 483	Deren Huang MD PhD - Form 483, 2016-08-04
October, 2010	FDA 483	Shishuka Malhotra MD - Form 483, 2010-10-14
May, 2003	FDA 483	GOJO Industries, Inc - Form 483, 2003-05-01
August, 2009	FDA 483 Response	Frontage Laboratories, Inc. - Form 483R, 2009-09-04
January, 2013	FDA 483	Shishuka Malhotra MD - Form 483, 2013-01-14
March, 2011	FDA 483	Mira Baron MD - Form 483, 2011-03-02
July, 2001	FDA 483	AGA Gas, Inc. - Form 483, 2001-07-19
December, 2012	EIR	Mira Baron MD - EIR, 2012-12-04
October, 2001	EIR	Donald E Hricik MD - EIR, 2001-10-23
January, 2015	FDA 483	Nashat Y Gabrail MD - Form 483, 2015-01-21
November, 2000	FDA 483	Gliatech Inc - Form 483, 2000-11-16
April, 2014	EIR	Jeffrey L. Blumer Ph.D MD - EIR, 2014-04-29
August, 2000	FDA 483	Gliatech Inc - Form 483, 2000-08-23

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