FDA Investigator Karen L Kosar

Karen L Kosar has conducted inspections on 400 sites in 15 countries as of 05 Mar 2021. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
400
Last Inspection Date:
05 Mar 2021
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Mexico, Canada, France, United Kingdom of Great Britain and Northern Ireland, Sweden, Germany, Italy, China, India, Denmark, Hungary, Estonia, Poland, Dominican Republic
FDA Investigators that have inspected at least one site in common with Karen L Kosar:
Abby E Pelletier, Alan L Truong, Alia Legaux, Alice S Tsao, Althea A Williams, Amal M Mansour, Amanda T Zick, 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, 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, David R Lattuca, 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 Lehr, Gary T Greco, George C Amedro, Gregson A 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 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 B Shah, 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, Jonah S Ufferfilge, Jose Acruz Gonzalez, Jose Ohernandez Guzman, Jose R Hernandez, 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, Junho Pak, Kara A Scheibner, PhD, 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, Kerun Hardeo, 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 Pyjas, Linda M Sacco, Lori Peters, Lucas B Leake, Luella J Rossi, Marc S Neubauer, Marcellinus D Dordunoo, 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 Spataro, Matthew B Casale, Matthew D Schnittker, Matthew W Kyle, Mel Szymanski, Melina Lrodriguez Upton, Michael A Charles, Michael F Skelly, PhD, Michael G Sinkevich, Michael Levin, 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 Varga, Miguel A Martinez Perez, Mihaly S Ligmond, Milan S Blake, Mindy M Chou, Miral B Patel, Mohsen Rajabi Abhari, FDA, Morris Paul, Mra Davism, Nancy L Neiger, Nancy M Espinal, Nancy T Waites, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, Nicholas C Mendiola, Nicole M Bell, Niketa Patel, Nima Ossareh, Noreen Muñiz, 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, 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, Seongeun Cho (Julia), PhD, 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, 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, Yiying E Chen, 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
August, 2012 FDA 483 Safetec of America Inc. - Form 483, 2012-08-08
May, 2012 EIR CooperSurgical, Inc. - EIR, 2012-05-23
February, 2006 FDA 483 Response Stryker Medical Buffalo dba Gaymar Industries Inc - Form 483R, 2006-03-03
July, 2004 EIR Mentholatum Company, The - EIR, 2004-07-22
April, 2017 EIR Stephane de Botton, M.D. - EIR, 2017-04-27
March, 2018 FDA 483 Michal Nowicki, Prof. Uniwersytecki Szpital Kliniczny NR 1 - Form 483, 2018-03-23
July, 2016 EIR ICON Development Solutions, LLC - EIR, 2016-07-22
May, 2002 EIR Messer LLC - EIR, 2002-05-24
November, 2019 EIR ICON Development Solutions, LLC - EIR, 2019-11-22
February, 2013 FDA 483 Mentholatum Company, The - Form 483, 2013-02-20
January, 2014 EIR Roswell Park Cancer Institute - EIR, 2014-01-23
May, 2009 FDA 483 ARCH CHEMICALS, INC. - Form 483, 2009-05-14
June, 2015 EIR ICON Development Solutions, LLC - EIR, 2015-06-26
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
July, 2008 EIR Contract Pharmaceuticals Limited Niagara - EIR, 2008-07-09
May, 2013 FDA 483 Central Radiopharmaceutical Services, Inc. - Form 483, 2013-05-06
February, 2006 EIR Stryker Medical Buffalo dba Gaymar Industries Inc - EIR, 2006-02-15
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
March, 2011 FDA 483 Immco Diagnostics, Inc. - Form 483, 2011-03-22
August, 2019 FDA 483 XGen Pharmaceuticals DJB, Inc. - Form 483, 2019-09-09
March, 2019 FDA 483 Vivek Reddy, M.D. - Form 483, 2019-03-07
March, 2012 FDA 483 World Gen LLC - Form 483, 2012-03-07
January, 2005 FDA 483 Contract Pharmaceuticals Limited Niagara - Form 483, 2005-01-31
October, 2019 EIR BioTel Research, LLC - EIR, 2019-10-03
February, 2013 EIR Mentholatum Company, The - EIR, 2013-02-20
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
July, 2015 FDA 483 United Health Services Hospitals, Inc. - Form 483, 2015-07-24
February, 2004 EIR Unither Manufacturing LLC - EIR, 2004-02-26
August, 2004 EIR Fresenius Kabi USA, LLC - EIR, 2004-08-30
December, 2003 EIR Promex Medical Inc - EIR, 2003-12-09
November, 2018 EIR Ascent Pharmaceuticals Inc - EIR, 2018-11-07
March, 2012 FDA 483 Response World Gen LLC - Form 483R, 2012-04-04
August, 2014 FDA 483 Elite Medical Supply of New York, LLC - Form 483, 2014-08-14
January, 2020 FDA 483 Allan B. Perel, M.D. - Form 483, 2020-01-23
November, 2011 FDA 483 Reichert, Inc. - Form 483, 2011-11-22
March, 2008 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2008-03-14
December, 2013 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2013-12-16
March, 2019 FDA 483 Marc Miller, M.D. - Form 483, 2019-03-08
April, 2009 FDA 483 Arkema Inc. - Form 483, 2009-04-17
March, 2017 EIR Intrinsic Therapeutics, Inc. - EIR, 2017-03-31
July, 2015 EIR United Health Services Hospitals, Inc. - EIR, 2015-07-24
May, 2002 FDA 483 Messer LLC - Form 483, 2002-05-24
June, 2015 EIR Unither Manufacturing LLC - EIR, 2015-06-01
May, 2012 FDA 483 CooperSurgical, Inc. - Form 483, 2012-05-23
January, 2005 EIR Contract Pharmaceuticals Limited Niagara - EIR, 2005-01-31
February, 2006 FDA 483 Stryker Medical Buffalo dba Gaymar Industries Inc - Form 483, 2006-02-15
February, 2016 EIR Algorithme Pharma Inc - EIR, 2016-02-26
April, 2016 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2016-04-18
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, 2007 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2007-02-07
July, 2013 FDA 483 Pine Pharmacy and Home Care Products Center, Inc. - Form 483, 2013-07-19
March, 2017 FDA 483 Lawrence B. Cohen - Form 483, 2017-03-03
February, 2010 FDA 483 SunMed Holdings, LLC - Form 483, 2010-02-09
January, 2014 FDA 483 Roswell Park Cancer Institute - Form 483, 2014-01-23
June, 2016 FDA 483 James C.-Y Chou, M.D. - Form 483, 2016-06-17
September, 2020 EIR Athenex, Inc. - EIR, 2020-09-17
February, 2010 EIR SunMed Holdings, LLC - EIR, 2010-02-09
February, 2004 EIR Linde Inc. - EIR, 2004-02-10
June, 2015 FDA 483 ICON Development Solutions, LLC - Form 483, 2015-06-26
August, 2014 EIR Elite Medical Supply of New York, LLC - EIR, 2014-08-14
April, 2019 FDA 483 Jerome Stevens Pharmaceuticals, Inc. - Form 483, 2019-04-11
December, 2017 FDA 483 David Straus, MD - Form 483, 2017-12-21

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