FDA Investigator Karen M Labounty

Karen M Labounty has inspections in 10 countries as of 27 Oct 2023. Karen M Labounty has collaborated with a combinined 5074 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
591
Last Inspection Date:
27 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, New Zealand, Italy, Bulgaria, Portugal, Mexico, North Macedonia, Canada, Germany
Co-Investigator(s):
Aaron L Dunbar, Abram A Brown, Adam J Taylor, Ahmad R Mcgowan, Aimee J Edwin, Alan R Albrecht, Alecia L Marson, Alfred P Pistorio, Alison A Nicoli, Amos, Amy F Anderson, Amy L Mcintyre, Ana M Placencia, Andrew F Cohen, Annemarie Kleiza, Anthony L Nicoli, Anthony P Duran, April L Young, Artem Melnik, Baask, Benjamin W Anderson, Billi Jom Johnson, Boun M Xiong, Bradley A Servais, Brant M Schroeder, Brent T Hall, Brian E Thompson, Brian L Szcyubialka, Brian P Hendrickson, Brian R Yaun, Brian Ravitch, Bruce W Benware, Bunce, Carolyn A Warren, Cary Greene, Catherine M Vanderhoef, Chantel D Stennis, Cheryl A Clausen, Cheryl D Mccall, Christina A Castineyra, Christine M Erickson, Christopher M Jenner, Ciara J Bajulai Austin, Clara E Santiago, Como, Cordelia J Brammer, Courtney R Ingalsbe, Courtney R Tiegs, Craig R Berger, Dacia E Quick, Dale A Nyberg, Darlene L Krieger, Darren D Holaday, David B Wieneke, David G Whitman, David J Ward, David P King, Dayle Radde, Debra D Devlieger, Demetria L Downs, Demetria L Lueneburg, Denise L Burosh, Diane T Kretschmer, Diane T Reindl, Dianna C Sonnenburg, Donald R Goldsmith, Doretha M Tonkins, Doretha M Wilson, Douglas J Snyder, Douglas R Nelson, Douglas W Atkins, Duc Minh H Nguyen, Edward A Fabiano, Edward M James, Edward Oshaughnessy, Elias H Wachter, Elizabeth E Hart (ASCP), MT, Elizabeth E Marc, Elizabeth P Mayer, Ellen C Weisensel, Emily E Harlow, Emily E Markgraf, Eric A Breselow, Eric R Holm, Eric Rothschild, Eric S Myskowski, Eric T Huebler, Fallon J Ryan, Fannie M Harrell, Frank S Sedzielarz, Frank Sedziewarz, Franklin D Heisler, Frederick J Tillman, Garrad R Poole, Garrett W Steiner, Gary C Pecic, Gerald T O'connor, Gina M Scholze, Grant L Davis, Grant M Ruis, Greg A Abel, Gregory S Larson, Gregory W Smith, Harry A Wilson, Heather Akleimola Hulbert, Heather Akleimola Hurbert, Heidi J Debeck, Henry E Sanchez, Holly J Smith, Howard A Burmester, Hung V Le, Hung Van Le, Hustedtj, Ismael Olvera, IV, Ivan E Reyes, J Benedict, Jaclyn N Munsch, Jacob W Reynolds, Jacqueline Johnson, Jake T Lane, James A Beaulieu, James P Stallings, James R Evans, Jamie R Thompson, Jane Chen, Jane E Nelson, Janis R Armedoriz, Jean M Bosenbecker, Jean M Trimbo, Jeffery A Hangartner, Jeffry A Bernhardt, Jennifer A Jones, Jennifer A Robinson, Jennifer Alongie Vollom, Jennifer Guttuso, Jennifer L Custodio, Jennifer M Heitz, Jennifer M Pouget, Jennifer R Mathern, Jennifer S Ness, Jeremy L Tri, Jeremy R Read, Jesse P Romenesko, Jessica L Barr, Jessica L Johnson, Jessica M Novak, Jocelyn M Muggli, Joel D Hustedt, John A Iwen, John E Emmert, John T Quaife, Jon C Polzine, Jonathan L Blonk, Joseph D Gong, Joseph J Golden, Joseph M Edwin, Juan A Morales, Julie Woodberry, Justin A Boyd, Ka L Wong, Karen M Gasperic, Karen M Jirele, Karen M, LaBounty, Karla J Youngberg, Katherine A Clarke Girolamo, Kathleen J Close, Kathryn M Mogen, Kathy Ac Girolamo, Kazar, Kellie L Thommes, RN, Kellie L Westerbuhr, Kenneth A Libertoski, Kevin L Torgerson, Kibily D Dembele, Kimberly Lewandowski Walker, Kimberly W Destromp, Kip J Hanks, Krista K Petersen, Kristy E Zuroski, Kyle J Mccracken, Larae M Koopman, Laura A Munsterman, Lauren E Merz, Lauren E Sanger, Lauren M Lilly, PhD, Leon R Stratman, Leonardm, Lewis K Antwi, Liliya V Bubiy, Linda V Weyer, Lucas B Leake, Mada A Tautges, Marc A Jackson, Jr, Margaret L Bolte, Margaret M Lubbers Solberg, Margo Cl Jones, Maria E Treadwell, Marie A Fadden, Marissa S Steinhagen, Marla A Cassidy, Mary Ann Ruff, Mary M Finn, Matthew B Casale, Meaghan M Rabideau, Megan E Kerry, Megan E Kulas, Melanie C Voges, Melissa D Kalik, Melissa I Michurski, Melissa J Holz, Melissaa D Kalik, Michael E Cimaglio, Michael T Nehring, Miles D Foster, Mohammed H Adam, Mpris Inspector, Nancy L Neiger, Nianna C Burns, Nianna M Capalia, Nicholas Fragedakis, Nicholas S Vasilakes, Nicole C Shokatz, Nicole C Victoria, PhD, Oluwaseyi Ojinni, Paola E Lathrop, Patricia A Holmstrom, Patricia P Wrona, Pedro A Cruz, Peter T Erlandson, Phal K Chhun, Ralph Jerndal, Randy L Clarida, Raymond M Lam, Rebecca L Caulfield, Rebecca L Keller, Rebecca L Mullikin, Rene M Amaguana, Rhonda L Mecl, Richard Jay Tucker, RS, Robert D Ogan, Robert H Claflin, Robert J Waldorf, Robert M Tillman, Ronald R Ruff, Ross J Grigsby, Rostislav Servetnyk, Samantha E Rafferty, Sana A Elassar, Sandra Sejdinovic, Sara Jdent Acosta, Sarah A Palmer, Scott A Golladay, Scott B Laufenberg, Scott L Schenian, Seth A Abbott, Shannon M Berg, Sharon K Thoma, PharmD, Sharon L Matson, Sharon M Harold, Shaun M Olson, Sonia D Hudson, State Agency, Steven A Skaar, Steven J Crowston, Susan M Matthias, Susan M Miller, Susan M North, Suzanne M Crotty, Tara C Singh, Tara M Carolfi, Terrance L Scheiber, Thanh M Andrews, Theresa C Klaman, Thomas S Donaldson, Timothy T Kapsala, Toni S Sturgis, Tony T Yang, Traci C Kelm, Tracy A Solseng, Travis S Bradley, Tressa T Lewis, Troy A Brenny, Verdell Nelson, Victoria L Palmer, Wayne W Grundstrom, Wendy L Trefethren Grang, William E Keer, William P Fournier, Yehualashet A Gessesse, Zachary P Wachlarowicz

Karen M Labounty's Documents

Publish Date Document Type Title
February, 2000 EIR Gerber Products Company dba Nestle Nutrition-Eau Claire - EIR, 2000-03-03
April, 2002 EIR Nestle Healthcare Nutrition Inc. - EIR, 2002-04-12
February, 2003 FDA 483 Aventis Bio-services, Inc. - Form 483, 2003-02-05
February, 2003 FDA 483 CSL Plasma Inc. - Form 483, 2003-02-26
June, 2017 FDA 483 Response Puris Proteins, LLC. - Form 483R, 2017-06-15
August, 2014 EIR Perrigo Wisconsin, LLC - EIR, 2014-08-01
June, 2013 EIR Perrigo Wisconsin, LLC - EIR, 2013-06-07
March, 2004 FDA 483 Response WuXi AppTec Inc - Form 483R, 2004-04-06
September, 2016 EIR Nestle Healthcare Nutrition Inc. - EIR, 2016-09-02
April, 2010 FDA 483 American National Red Cross (The) - Form 483, 2010-04-23
June, 2017 FDA 483 Puris Proteins, LLC. - Form 483, 2017-06-12
March, 2000 EIR Nestle Healthcare Nutrition Inc. - EIR, 2000-03-24
September, 2015 EIR Nestle Healthcare Nutrition Inc. - EIR, 2015-09-04
December, 2002 EIR Aventis Bio-services, Inc. - EIR, 2002-12-09
September, 2011 FDA 483 Nestle Healthcare Nutrition Inc. - Form 483, 2011-09-27
July, 2016 EIR Perrigo Wisconsin, LLC - EIR, 2016-07-28
April, 2009 FDA 483 Minnesota Molecular and Cellular Therapeutics Facility - Form 483, 2009-04-17
March, 2009 EIR University of Minnesota Medical Center, Fairview - EIR, 2009-03-30
March, 2009 FDA 483 University of Minnesota Medical Center, Fairview - Form 483, 2009-03-30
December, 2002 EIR Aventis Bio-services, Inc. - EIR, 2002-12-09
July, 2019 EIR Perrigo Wisconsin, LLC - EIR, 2019-07-12
September, 2003 FDA 483 Kay's Processing LLC - Form 483, 2003-09-11
July, 2001 FDA 483 Mead Johnson and Co., LLC - Form 483, 2001-07-12
May, 2006 EIR Nestle Healthcare Nutrition Inc. - EIR, 2006-05-24
March, 2000 FDA 483 Nestle Healthcare Nutrition Inc. - Form 483, 2000-03-24
July, 2016 FDA 483 Perrigo Wisconsin, LLC - Form 483, 2016-07-28
June, 2000 EIR Mead Johnson and Co., LLC - EIR, 2000-06-21
June, 2009 FDA 483 Innovative Blood Resources - Form 483, 2009-06-11
August, 2010 EIR Nestle Healthcare Nutrition Inc. - EIR, 2010-08-13
April, 2017 FDA 483 TreeHouse Private Brands, Inc. - Form 483, 2017-04-12
April, 2011 FDA 483 Forsman Farms, Inc. - Form 483, 2011-04-15
September, 2018 FDA 483 Flagstone Foods Inc. - Form 483, 2018-09-28
February, 2005 EIR WuXi AppTec Inc - EIR, 2005-02-08
February, 2003 EIR CSL Plasma Inc. - EIR, 2003-02-26
September, 2013 EIR Nestle Healthcare Nutrition Inc. - EIR, 2013-09-27
July, 2015 EIR Perrigo Wisconsin, LLC - EIR, 2015-07-17
January, 2001 EIR Gerber Products Company dba Nestle Nutrition-Eau Claire - EIR, 2001-01-30
August, 2000 EIR University of Minnesota Medical Center, Fairview - EIR, 2000-08-31
November, 2000 EIR Hearthside Food Solutions, LLC - EIR, 2000-11-08
June, 2021 EIR Nestle Healthcare Nutrition Inc. - EIR, 2021-06-11
April, 2009 EIR Minnesota Molecular and Cellular Therapeutics Facility - EIR, 2009-04-17
February, 2003 EIR Aventis Bio-services, Inc. - EIR, 2003-02-05
May, 2011 FDA 483 Sparboe Farms / Prairie Complex - Form 483, 2011-05-05
June, 2017 FDA 483 SunOpta Grains and Foods, Inc. - Form 483, 2017-06-30
March, 2004 FDA 483 WuXi AppTec Inc - Form 483, 2004-03-04
April, 2022 FDA 483 Perrigo Wisconsin, LLC - Form 483, 2022-04-14
September, 2014 EIR Nestle Healthcare Nutrition Inc. - EIR, 2014-09-19
September, 2001 EIR Nestle Healthcare Nutrition Inc. - EIR, 2001-09-21
September, 2018 EIR Nestle Healthcare Nutrition Inc. - EIR, 2018-09-14
December, 2001 EIR Perrigo Wisconsin, LLC - EIR, 2001-12-14
July, 2017 EIR Perrigo Wisconsin, LLC - EIR, 2017-07-14
July, 2001 EIR Mead Johnson and Co., LLC - EIR, 2001-07-12
March, 2006 FDA 483 Musculoskeletal Transplant Foundation - Form 483, 2006-03-03
July, 2008 FDA 483 Laboratory Corporation of America ViroMed Laboratories - Form 483, 2008-07-24
July, 2021 EIR Mead Johnson and Co., LLC - EIR, 2021-07-23
May, 2019 FDA 483 Mead Johnson and Co., LLC - Form 483, 2019-05-31
January, 2023 FDA 483 Mead Johnson and Co., LLC - Form 483, 2023-01-09
May, 2023 FDA 483 Abbott Laboratories Inc. - Form 483, 2023-06-07
January, 2024 FDA 483 Mead Johnson and Co., LLC - Form 483, 2024-01-10

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