FDA Investigator Karen L Kosar

Karen L Kosar has inspections in 16 countries as of 07 Nov 2023. Karen L Kosar has collaborated with a combinined 5806 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
400
Last Inspection Date:
07 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, United Kingdom of Great Britain and Northern Ireland, Poland, Hungary, Germany, India, Sweden, France, Canada, Estonia, Dominican Republic, Italy, Mexico, China, Denmark
Co-Investigator(s):
Abby E Pelletier, Alan L Truong, Alia Legaux, Alice S Tsao, Althea A Williams, Amal M Mansour, Amatul H Marium, Amber D Brodas, Amy Kim, Amy S Graf, Ana P Pineda Zavaleta, Anastasia M Shields, Andrew B Paglia, DPM, Andrew M Abramowitz, Ann B Okon, Anna Lazar, Anthony E Keller, RPh, Anthony Kovalenko, Anthony N Onianwa, Antonina Aydanian, Arduino Frankovic, Ariel Cruz Figueroa, Arthur G Hurst, Azza Talaat, Benton M Ketron, Bijoy Panicker, Brandy N Lepage, Brenda A Kraengel, Brian J Ryan, Bruce G Cooper, Cara M Minelli, Carl A Anderson, Carolyn J Cook, Cassandra L Winters, Charanjeet Jassal, Charisse K Green, Charles Jewell, Charles R Cote, RIC, Cheryl L Manney, Christian Parra, Christopher S Fields, Christopher S Keating, Crystal A Branch, Cynthia A Stempniak, D Jenny Argiropoulos, Daniel L Aisen, David A Carlson, David A Trent Carlson, David J Eide, David J Feria, David J Leray, David M Beltran, David M Mcnew, David R Delucia, Dean R Rugnetta, Deborah A Greco, Demitria J Argiropoulos, Demitria J Xiradakis, Denise L Terzian, Dennis E Guilfoyle, PhD, Diamond M Oden, Diane E Bruce, Diane L Raccasi, Dianiris C Ayala, Dipesh K Shah, Donald G Gordon, Donald J Ullstrom, Douglas G Ng, Dr. Abhijit Raha, PhD, Dr. Jason R Caballero, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Elizabeth H Davis, Elizabeth H Slazak, Emest F Bizjak, Erika E Englund, PhD, Erin L Nagel, Evelyn Taha, Feiyan Jin, Felix Maldonado, Freyja V Lynn, Gabriel Davila, Gam S Zamil, Gary J Lader, Gary J Lehr, Gary T Greco, George C Amedro, Gregson A Joseph, Gregson Joseph, Guerlain Ulysse, Harry J Brewer, Helen B Ricalde, Helen Verdel, Hilary K Wagner, Hoimay Chan, Hugh M Mcclure, II, Iram R Hassan, PhD, Irina Gaberman, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Liubicich, James C Maclaughlin, James D Bridges, James M Kewley, James M Mason, Janet A Rajan, Janete F Guardia, Jay T Wong, Jazmine N Brown, Jeanette L Mcginnis, Jeffery A Hangartner, Jeffrey A Sommers, Jennifer L Bridgewater, Joanne M Schlossin, Joel R Merriman, Joey V Quitania, John A Podsadowski, John P Mistler, Johnna L Bleem, Jose Acruz Gonzalez, Jose O Hernandez, Jose R Hernandez, Joseph A Famigiletti, Joseph A Famiglietti, Joseph J Vannelli, Joseph Maselli, Joseph Milcetic, Joseph T Frost, Joshua D Lopez, Joy P Matthias, Joyce A Williams, Juan Rjimenez Garcia, Judy Keihl, Julie Scoma, Karan L Blum, Karen A Morgante, Karen M Cooper, Karen M Montgomery (KMM), Katherine Szestypalow, Kathryn A Nagy, Kellie Leveille, Kenneth G Klobus, Kenneth H Williams, Kevin A Gonzalez, Kim Lthomas Cruse, Kim M Downing, Kimberley A Gordon, Kimberley A Ricketts, Kimberly Y Smithson, Kip J Hanks, Kristina L Conroy, Kyle J Spencer, L Gnnmassimia Massimilla, PharmD, Lata C Mathew, PhD, Lauren E Blaser, Laurie A Haxel, Laurie B Frazier, LCDR Chad N Thompson, Leena Thomas, Linda M Pyias, Linda M Sacco, Linda S Leja, Lori P Peters, Lucas B Leake, Luella J Rossi, Marc S Neubauer, Marcellinus D Dordunoo, Mare S Neubauer, Margaret E Sarles, Margaret M Annes, Maria Estrella, Maria Joselopez Barragan, PhD, Marjorie A Shapiro, PhD, Mark A Heard, Marlene L Davis, Marsha W Major, Martha T Olone, Mary Davis Lopez, Mary M Finn, Mary T Carden, Mate Tolnay, Matthew A Sparato, Matthew A Spataro, Matthew B Casale, Matthew D Schnittker, Matthew W Kyle, Melina Lrodriguez Upton, Michael A Charles, Michael F Skelly, PhD, Michael G Sinkevich, Michael Levin, Michael Levine, Michael P Sheehan, Michael P Sweeney, Michael R Dominick, Michael Serrano, Michael W Burd, Michele L Obert, Michele Perry Williams, Michelle C Roberts, Michelle M Noe, Miguel A Martinez, Miguel A Martinez Perez, Mihaly S Ligmond, Milan S Blake, Mindy M Chou, Miral B Patel, Mohsen Rajabi Abhari, FDA, Morris Paul, Mpris Inspector, Mra Davism, Muchael W Burd, Nancy L Neiger, Nancy M Espinal, Nancy T Waites, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, Nicholas C Mendiola, Niketa Patel, Nima Ossareh, Noreen Muniz, Omadevi Somai, Investigator, Omotunde O Osunsanmi, Parul M Patel, Patricia A Clark, Patrick C Klotzbuecher, Paul E Stein, Paul Mouris, Paula A Trost, Paula J Bretz, Perez, Perry T Nichols, Peter Abel, Peter M Trunk, Peter R Caparelli, Peter S Diak, Philip F Istafanos, DMV, MS, Phyllis J Wilson, Prabhu P Raju, Rachael A Moliver, Rafael Nevarez Nieves, Rajiv R Srivastava, Randi Lynn Bodoh, Randi Lynn Spencer, Rebecca Rodriguez, Regina M Bennett, Rene R Ramirez, Rhoda B Eniafe, Richard K Glabach, Richard W Thornton, Robert C Steyert, Robert J Maffei, Robert J Veitch, Robert Jennings, Robert W Jennings, Roberto A Dookhan, Rose Xu, Russ E Davis, Russell J Glapion, Samuel T Walker, Sandra A Hughes, Sandra D Thompson, Sangeeta M Khurana, PhD, Santos E Camara, Sarah A Meehan, Sarah B Tanksley, Sargum C Sood, Sasha M Latonis, Satheesh Thomas, Sayyem H Akbar, Scott E Norris, Shannon A Dinardo, Sherri J Jackson, Shirley J Berryman, Shreya Shah, Simone E Pitts, Sixto M Mercado Rios, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, State Agency, Stephen C Smith, Steven E Bowen, PhD, Steven J Libal, Stuart W Russell, Susan D Yuscius, Susan F Laska, MS, Susan M Jackson, Susan W Ting, Suyang Qin, Syeda N Mahazabin, Taichun Qin, PhD, Tammy S Notto, Tania E Vizcaino, Tanya R Syffrard, Tara K Carmody, Tara K Normandin, Tawny L Colling, Thomas J Dinunzio, Thomas J Mooney, Thomas L Bellonte, Thomas P Hansen, Timothy T Kapsala, Tina S Roecklein, Tracy M Portelli, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Uduak M Inokon, Vickie J Kanion, Vien Q Le, Vivin George, Wayne E Seifert, Wendy G Tan, PhD, Wendy M Stone, William C Lubas, William J Leonard, William M Rennells, William P Chilton, Xiaohan Cai, PhD, Yiyue Zhang (nmi), PhD, Yuyan Liang, Yvesna C Blaise, Yvins Dezan, Yvonne C Mcknight, Zhongren Wu

Karen L Kosar's Documents

Publish Date Document Type Title
March, 2011 FDA 483 Immco Diagnostics, Inc. - Form 483, 2011-03-22
August, 2014 EIR Elite Medical Supply of New York, LLC - EIR, 2014-08-14
February, 2007 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2007-02-07
March, 2017 FDA 483 Lawrence B. Cohen - Form 483, 2017-03-03
May, 2002 FDA 483 Messer LLC - Form 483, 2002-05-24
January, 2013 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2013-01-11
July, 2015 FDA 483 Response United Health Services Hospitals, Inc. - Form 483R, 2015-08-04
February, 2004 EIR Linde Inc. - EIR, 2004-02-10
May, 2012 FDA 483 CooperSurgical, Inc. - Form 483, 2012-05-23
February, 2016 EIR Altasciences Company Inc. - EIR, 2016-02-26
March, 2012 FDA 483 World Gen LLC - Form 483, 2012-03-07
January, 2021 FDA 483 Genovefa A Papanicolaou, MD - Form 483, 2021-01-27
April, 2008 FDA 483 International Chemical Inc. - Form 483, 2008-04-11
January, 2005 FDA 483 Contract Pharmaceuticals Limited Niagara - Form 483, 2005-01-31
November, 2018 EIR Ascent Pharmaceuticals Inc - EIR, 2018-11-07
July, 2015 FDA 483 United Health Services Hospitals, Inc. - Form 483, 2015-07-24
March, 2012 FDA 483 Response World Gen LLC - Form 483R, 2012-04-04
March, 2019 FDA 483 Vivek Reddy, M.D. - Form 483, 2019-03-07
February, 2013 EIR Mentholatum Company, The - EIR, 2013-02-20
June, 2015 EIR ICON Development Solutions, LLC - EIR, 2015-06-26
January, 2014 EIR Roswell Park Cancer Institute - EIR, 2014-01-23
April, 2017 EIR Stephane de Botton, M.D. - EIR, 2017-04-27
August, 2019 FDA 483 X-Gen Pharmaceuticals Inc. - Form 483, 2019-09-09
August, 2004 EIR Fresenius Kabi USA, LLC - EIR, 2004-08-30
October, 2019 EIR BioTel Research, LLC - EIR, 2019-10-03
November, 2019 EIR ICON Development Solutions, LLC - EIR, 2019-11-22
July, 2013 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2013-07-19
January, 2020 FDA 483 Allan B. Perel, M.D. - Form 483, 2020-01-23
July, 2016 EIR ICON Development Solutions, LLC - EIR, 2016-07-22
July, 2008 EIR Contract Pharmaceuticals Limited Niagara - EIR, 2008-07-09
June, 2019 FDA 483 Richard W. Foltin, Ph.D. - Form 483, 2019-06-21
May, 2011 FDA 483 Arnold Tuber Industries, LLC - Form 483, 2011-05-27
August, 2014 FDA 483 Elite Medical Supply of New York, LLC - Form 483, 2014-08-14
November, 2011 FDA 483 Reichert, Inc. - Form 483, 2011-11-22
September, 2008 FDA 483 American National Red Cross (the) - Form 483, 2008-09-26
August, 2011 FDA 483 Upstate New York Transplant Services Inc - Form 483, 2011-08-05
February, 2006 EIR Stryker Medical Buffalo dba Gaymar Industries Inc - EIR, 2006-02-15
March, 2008 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2008-03-14
May, 2013 FDA 483 Central Radiopharmaceutical Services, Inc. - Form 483, 2013-05-06
March, 2017 EIR Intrinsic Therapeutics, Inc. - EIR, 2017-03-31
June, 2015 EIR Unither Manufacturing LLC - EIR, 2015-06-01
December, 2017 FDA 483 David Straus, MD - Form 483, 2017-12-21
June, 2016 FDA 483 James C.-Y Chou, M.D. - Form 483, 2016-06-17
April, 2016 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2016-04-18
February, 2006 FDA 483 Stryker Medical Buffalo dba Gaymar Industries Inc - Form 483, 2006-02-15
February, 2010 FDA 483 SunMed Holdings, LLC - Form 483, 2010-02-09
March, 2019 FDA 483 Marc Miller, M.D. - Form 483, 2019-03-08
May, 2002 EIR Messer LLC - EIR, 2002-05-24
February, 2006 FDA 483 Response Stryker Medical Buffalo dba Gaymar Industries Inc - Form 483R, 2006-03-03
March, 2018 FDA 483 Michal Nowicki, Prof. Uniwersytecki Szpital Kliniczny NR 1 - Form 483, 2018-03-23
February, 2004 EIR Unither Manufacturing LLC - EIR, 2004-02-26
April, 2019 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2019-04-11
December, 2003 EIR Promex Medical Inc - EIR, 2003-12-09
January, 2014 FDA 483 Roswell Park Cancer Institute - Form 483, 2014-01-23
August, 2012 FDA 483 Safetec of America, Inc. - Form 483, 2012-08-08
June, 2015 FDA 483 ICON Development Solutions, LLC - Form 483, 2015-06-26
December, 2013 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2013-12-16
July, 2015 EIR United Health Services Hospitals, Inc. - EIR, 2015-07-24
July, 2004 EIR Mentholatum Company, The - EIR, 2004-07-22
April, 2009 FDA 483 Arkema Inc. - Form 483, 2009-04-17
January, 2005 EIR Contract Pharmaceuticals Limited Niagara - EIR, 2005-01-31
September, 2020 EIR Athenex, Inc. - EIR, 2020-09-17
May, 2012 EIR CooperSurgical, Inc. - EIR, 2012-05-23
May, 2009 FDA 483 ARCH CHEMICALS, INC. - Form 483, 2009-05-14
February, 2010 EIR SunMed Holdings, LLC - EIR, 2010-02-09
February, 2013 FDA 483 Mentholatum Company, The - Form 483, 2013-02-20

Experience Redica Systems’ NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more