FDA Investigator Denise L Burosh

Denise L Burosh has conducted inspections on 553 sites in 27 countries as of 24 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
553
Last Inspection Date:
24 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100009412
Countries of Inspections:
United States of America, Czechia, Taiwan, Mexico, India, Spain, Germany, Canada, Argentina, China, Poland, Cyprus, Honduras, Korea (Republic of), Greece, Brazil, France, Thailand, Italy, Georgia, Serbia, Netherlands, South Africa, Belgium, Philippines, Singapore, Portugal
FDA Investigators that have inspected at least one site in common with Denise L Burosh:
Aaron L Dunbar, Adam J Taylor, Aimee J Edwin, Alecia L Marson, Alexander M Kay, Allen F Hall, Amanda Dinaro, Amanda S Zorn, Amir Alavi, Ana E Morales, Anders W Evenson, Andrace L Deyampert, Andrea D Swingle, Andrew A Leboeuf, Anthony E Keller, RPh, Anthony F Lorenzo, Anthony J Ladner, Anthony P Duran, Anya Dlockett Evans, April L Young, Bei Y He, Benjamin J Smith, Benjamin W Anderson, Betsy C Galliher, Billi Jom Johnson, Boun M Xiong, Brian D Nicholson, Brian L Szcyubialka, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Camille D Brown, Carl A Huffman, III, Catherine M Vanderhoef, CDR Sean T Creighton, Chad E Schmear, Charles I Ann, Charles L Zhou, Charles R Bonapace, PhD, Charles R Cote, RIC, Chase Bourke, PhD, Christina A Castineyra, Christina L Bigham, Christopher D Leach, Conor J Mccarron, Constance L Richard, Constantin Y Philopoulos, Corey K Reno, Corrine M Carter, Courtney R Ingalsbe, Courtney R Tiegs, Craig T Rybus, Cynthia A Harris, MD, RN, Dacia E Quick, Dale A Nyberg, Daniel L Aisen, Darla J Christopher, Darlene L Krieger, Darrell E Luedtke, David A Paterson, David J Gasparovich, David Perkins, Dawn C Olenjack, Debara R Reese, Debara Reese, Debra I Love, Debra Lboyd Seale, Demetria L Lueneburg, Denise M Digiulio, Dennis E Guilfoyle, PhD, Diane Kretschmer, Diane T Reindl, Dina A Tallman, Donald C Obenhuber, PhD, Dr. Gang Wang, PhD, Dr. Gopa Biswas, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Edward D Mcdonald, Edward E Lockwood (EEL), Eileen A Liu, Elias H Wachter, Elizabeth E Hart (ASCP), MT, Ellen C Weisensel, Emest F Bizjak, Emily J Orban, Emily S Mcgann, Eric A Breselow, Eric C Fox, Eric M Mueller, PharmD, Eric S Myskowski, Eric S Pittman, Eric T Huebler, Erma Zaimova, Fannie M Harrell, Gajendiran Mahadevan, PhD, Gloria A Milster, Grant M Ruis, Gregory R Brinsley, Gregory R Dill, Gregory S Larson, Gregory W Smith, Himanshu Gupta, PhD, Hoimay Chan, Howard A Burmester, Hugh M Mcclure, II, Humera T Khan, Hyojong Kwon, PhD, Ifueko Osemwota, Ivan E Reyes, Jaclyn N Munsch, Jacob W Reynolds, Jacqueline Mdiaz Albertini, James A Beaulieu, James K Ireland, James W Plucinski, Jamie R Thompson, Jane E Nelson, Janete F Guardia, Janis R Armedoriz, Jasjeet K Sekhon, Jean Blackston Hill, Jean M Bosenbecker, Jeanne J Thai, Jeanne M Morris, Jeffery A Hangartner, Jeffrey A Sommers, Jeffrey D Meng, Jeffry A Bernhardt, Jennifer A Kemp, Jennifer A Longie Vollom, Jennifer Al Vollon, Jennifer Guttuso, Jennifer S Ness, Jesse A Vazquez, Jesse P Romenesko, Jessica G Spinuzza, Jessica L Barr, Joanne M Schlossin, Jocelyn M Muggli, Joel D Hustedt, Joel D Martinez, John A Iwen, John A Kadavil, PhD, John E Emmert, John P Hermann, Jon C Polzine, Jonathan G Swoboda, Jonathan R Campos, Joseph A Piechocki, Joseph M Edwin, Joseph R Strelnik, Justin A Boyd, Justin J Jafferis, Jyoti B Patel, PhD, Kaarin M Slotte, Kara A Scheibner, PhD, Karen Emasley Joseph, Karen M Cooper, Karen M Gasperic, Karen M Labounty, Karen M Montgomery (KMM), Karla J Youngberg, Katherine A Clarke Girolamo, Kathleen B Swat, Kathryn M Mogen, Kathy Ac Girolamo, Keith C Rindahl, Kellie L Thommes, RN, Kellie L Westerbuhr, Kenneth A Libertoski, Kevin P Regan, Kham Phommachanh, Kia L Copeland, Kimberly Lewandowski Walker, Kimberly W Destromp, Kip J Hanks, Kristy E Zuroski, Kyran R Gibson, L'oreal F Walker, Lakecha N Lewis, Larry K Austin, Laureen F Kononen, Lauren Iacono Connors, PhD, Lauren M Lilly, PhD, Laverne Puckett, Lee Terry Moore, Leigh Anne Myers, Leon R Stratman, Leonardm, Lequita M Mayhew, Lewis K Antwi, Liliya V Bubiy, Linda Thai, Linda V Weyer, Lisa Hayka, Lisa M Bellows, Lisa M Lopez, Lisa P Oakes, Lorelei S Jarrell, Lori A Gioia, Lori B Wikstrom, Lourdes Andujar, Luella J Rossi, Mada A Tautges, Makini Cobourne Duval, PhD, Maksim A Levenchuk, Marc A Jackson, Jr, Margaret Torres Vazquez, Marie A Fadden, Marissa S Steinhagen, Mark E Frank, Martin K Yau, PhD, Mary M Finn, Maryann Ruff, Meisha R Sampson, Meisha Waters, Melanie C Voges, Melina Lrodriguez Upton, Melissa D Kalik, Melissa J Holz, Mercy Oyugi, Michael A Blaine, Michael F Skelly, PhD, Michael G Sinkevich, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michelle J Glembin, Michelle J Hines, Mike M Rashti, Mildred J Tures, Mohsen Rajabi Abhari, FDA, Montgomery Montgomery, Karen M, Muna Algharibeh, Muralidhara B Gavini, PhD, Myra K Casey, Nailing Zhang, Nancy A Bellamy, Natalie A Mickelsen, DVM, Natalie E Starczowski, Neali H Lucas, Nicholas T Domer, Nicholas Z Lu, Nicole C Shokatz, Nicole C Victoria, PhD, Norman Wong, Pankaj H Amin, Paola E Lathrop, Paola S Barnett, Parul M Patel, Patricia A Cochran, Patricia A Mcilroy, Patricia H Dlugosz, Patricia S Smith, Patrick B Cummings, Patrick J Campbell, Patsy J Domingo, Paul A Bonneau, Peter T Erlandson, Phung Thien Nguyen, Prabhu P Raju, Qiao Y Bobo, Rachel T Evans, Rafael A Kaup, Rafeeq A Habeeb, Ralph Jerndal, Raymond T Oji, Rebecca E Dombrowski, Rebecca L Mullikin, Richard Jay Tucker, RS, Richard M Willey, Richard W Berning, Richard W Koller, Robert D Tollefsen, Robert J Ham, Robert J Waldorf, Robert M Barbosa, Robert M Tillman, Robert W Hudson, Roberta W Cunningham, Ronald R Ruff, Rose Ashley, Ross J Grigsby, Rostislav Servetnyk, Russell K Riley, Saikat I Bhuiyan, Sandra A Boyd, Sandra A Hughes, Sandra D Wilson, Sandra Sejdinovic, Sarah A Palmer, Sarah E Rhoades, Scott A Golladay, Scott B Laufenberg, Shalonda C Clifford, Sharon K Thoma, PharmD, Sharon L Matson, Shaun M Olson, Sherri J Jackson, Simone E Pitts, Srinivas R Chennamaneni, PhD, Stephen D Eich, Steven A Skaar, Susan F Laska, MS, Susan M Matthias, Susan M Miller, Susan M North, Susan P Bruederle, Suyang Qin, Suzanne M Crotty, Tamara Brey, Tara C Singh, Tara M Carolfi, Tara M Humfeld, Tawny L Colling, That Q Dang, Theresa M Spicer, Thomas J Arista, Thomas W Garvin, Thuy T Nguyen, LCDR, Tina M Pawlowski, Todd M Stankewicz, Tony T Yang, Tracy A Solseng, Travis S Bradley, Tyler R Courtney, Wayne E Seifert, Wayne W Grundstrom, William D Tingley, William F Lagud, Jr, William P Fournier, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Yangmin Ning, Yehualashet A Gessesse, Yiyue Zhang (nmi), PhD, Yuanyuan Li, Yumi J Hiramine, Zoey A Trombley

Denise L Burosh's Documents

Publish Date Document Type Title
March, 2019 FDA 483 Richy Agajanian, M.D. - Form 483, 2019-03-07
December, 2004 FDA 483 Croissant Etc. Corp. - Form 483, 2004-12-14
November, 2017 FDA 483 Ascension Clinical Research Institute IRB - Form 483, 2017-11-09
May, 2002 FDA 483 Response Versiti Wisconsin, Inc - Form 483R, 2002-06-12
May, 2012 FDA 483 Rhead, William J., M.D. - Form 483, 2012-05-03
May, 2011 FDA 483 American Preclinical Services - Form 483, 2011-05-04
March, 2015 FDA 483 Response Lazzaro, Marc, MD - Form 483R, 2015-04-10
May, 2002 FDA 483 Versiti Wisconsin, Inc - Form 483, 2002-05-23
December, 2000 FDA 483 International Bio Resources LLC - Form 483, 2000-12-01
June, 2018 FDA 483 Faro Ted Owiesy - Form 483, 2018-06-27
December, 2002 EIR BloodCenter of Wisconsin Inc. Wisconsin Tissue Bank - EIR, 2002-12-17
May, 2019 EIR Spaulding Clinical Research, LLC - EIR, 2019-06-21
November, 2012 EIR Agnesian Healthcare IRB - EIR, 2012-11-13
August, 2019 EIR Findling, James W., M.D. - EIR, 2019-08-02
June, 2015 FDA 483 Response Geneva Laboratories, Inc. - Form 483R, 2015-06-29
March, 2016 EIR Coating Place Inc - EIR, 2016-03-01
January, 2016 FDA 483 Kyung Wan Min, M.D. - Form 483, 2016-01-14
June, 2014 FDA 483 Response Agnesian Healthcare IRB - Form 483R, 2014-07-03
September, 2016 FDA 483 Response Biomat USA, Inc. DBA Grifols PlasmaCare, Inc. - Form 483R, 2016-09-29
February, 2014 EIR GE Medical Systems, LLC - EIR, 2014-02-28
March, 2017 EIR PPD Development, L.P. - EIR, 2017-03-03
March, 2022 FDA 483 Nancy Kim, M.D. - Form 483, 2022-03-25
November, 2000 FDA 483 Aventis Bio-Services Inc. - Form 483, 2000-11-30
June, 2012 EIR Geneva Laboratories, Inc. - EIR, 2012-06-15
June, 2015 EIR Geneva Laboratories, Inc. - EIR, 2015-06-11
September, 2015 EIR Wisconsin Pharmacal Company, LLC - EIR, 2015-09-04
June, 2014 EIR Agnesian Healthcare IRB - EIR, 2014-06-17
September, 2017 FDA 483 Michael W. Deininger, M.D., Ph.D. - Form 483, 2017-09-01
May, 2015 FDA 483 Modern Products, Inc. - Form 483, 2015-05-13
August, 2018 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2018-08-24
November, 2012 FDA 483 Agnesian Healthcare IRB - Form 483, 2012-11-13
February, 2001 EIR International Bio Resources LLC - EIR, 2001-02-26
August, 2009 EIR Lotus Light Enterprises, Inc - EIR, 2009-08-05
July, 2023 FDA 483 Ascension Clinical Research Institute IRB - Form 483, 2023-07-24
June, 2014 FDA 483 Agnesian Healthcare IRB - Form 483, 2014-06-17
November, 2022 FDA 483 Anastasia Kotanidou, MD - Form 483, 2022-11-04
August, 2021 FDA 483 Findling, James W., M.D. - Form 483, 2021-08-26
October, 2021 FDA 483 Alexandra Rogers, MD - Form 483, 2021-10-01
September, 2019 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2019-09-05
July, 2000 EIR International Bio Resources LLC - EIR, 2000-07-18
November, 2023 FDA 483 Jan Matousek, D.O. - Form 483, 2023-11-16
October, 2021 EIR Alexandra Rogers, MD - EIR, 2021-10-01
June, 2018 EIR Faro Ted Owiesy - EIR, 2018-06-27
May, 2024 FDA 483 Mara Piltin, D.O. - Form 483, 2024-05-03
December, 2000 EIR International Bio Resources LLC - EIR, 2000-12-01
November, 2021 FDA 483 Surmodics Inc - Form 483, 2021-11-04
March, 2017 FDA 483 PPD Development, L.P. - Form 483, 2017-03-03
August, 2023 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2023-08-30
September, 2020 FDA 483 Robert M. Haws, M.D. - Form 483, 2020-09-04
February, 2013 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2013-02-15
April, 2016 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2016-04-08
February, 2023 FDA 483 Donald M Brandon MD - Form 483, 2023-02-24
February, 2017 FDA 483 Spaulding Clinical Research, LLC - Form 483, 2017-02-02
February, 2000 EIR International Bio Resources LLC - EIR, 2000-02-18
November, 2014 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2014-11-03
June, 2021 FDA 483 D'Alessandro, Anthony M. - Form 483, 2021-06-18
March, 2018 FDA 483 Hardten, David R., MD, Clinical Investigator - Form 483, 2018-03-09
August, 2012 FDA 483 Versiti Wisconsin, Inc - Form 483, 2012-08-10
February, 2019 FDA 483 Aukstuolis, Jim G., MD - Form 483, 2019-02-01
March, 2015 EIR Lazzaro, Marc, MD - EIR, 2015-03-23
November, 2012 FDA 483 Response Agnesian Healthcare IRB - Form 483R, 2012-11-21
September, 2016 FDA 483 Biomat USA, Inc. DBA Grifols PlasmaCare, Inc. - Form 483, 2016-09-09
July, 2022 FDA 483 Inotiv, Inc - Form 483, 2022-07-14
May, 2022 FDA 483 Children's Hosp Of WI Institutional Review Board - Form 483, 2022-07-19
March, 2015 FDA 483 Lazzaro, Marc, MD - Form 483, 2015-03-23
November, 2014 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2014-11-03
April, 2017 FDA 483 Pedro Daniel Zangroniz - Form 483, 2017-04-21
October, 2022 FDA 483 Covance Cru Inc - Form 483, 2022-10-07
July, 2000 FDA 483 International Bio Resources LLC - Form 483, 2000-07-18
December, 2017 FDA 483 Surpass, Inc. - Form 483, 2017-12-07
February, 2014 FDA 483 GE Medical Systems, LLC - Form 483, 2014-02-28
December, 2001 FDA 483 International Bio Resources LLC - Form 483, 2001-12-19
December, 2002 EIR International Bio Resources LLC - EIR, 2002-12-16
December, 2011 FDA 483 Quincy Bioscience Holding Company Inc. - Form 483, 2011-12-22
December, 2001 EIR International Bio Resources LLC - EIR, 2001-12-19
January, 2022 EIR Eli Lilly and Company - EIR, 2022-01-13
April, 2018 FDA 483 Geneva Laboratories, Inc. - Form 483, 2018-04-05
May, 2019 FDA 483 Bellin Health System Inc., IRB - Form 483, 2019-05-09
February, 2020 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2020-03-20
February, 2001 FDA 483 International Bio Resources LLC - Form 483, 2001-02-26
February, 2000 FDA 483 International Bio Resources LLC - Form 483, 2000-02-18
August, 2019 FDA 483 Findling, James W., M.D. - Form 483, 2019-08-02
May, 2004 EIR Versiti Wisconsin, Inc - EIR, 2004-05-21
January, 2021 FDA 483 Rowena Punzalan, M.D. - Form 483, 2021-01-15
May, 2002 EIR Versiti Wisconsin, Inc - EIR, 2002-05-23
November, 2005 FDA 483 Biomat USA Inc. DBA Talecris Plasma Resources - Form 483, 2005-11-28
June, 2015 FDA 483 Geneva Laboratories, Inc. - Form 483, 2015-06-11
September, 2016 EIR Biomat USA, Inc. DBA Grifols PlasmaCare, Inc. - EIR, 2016-09-09
August, 2018 FDA 483 Fons, Roger A. - Form 483, 2018-08-09
April, 2016 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2016-04-08
January, 2024 FDA 483 Lynn Malec, M.D. - Form 483, 2024-01-08
May, 2015 EIR Kleen Test Products Corporation - EIR, 2015-05-20
August, 2002 EIR International Bio Resources LLC - EIR, 2002-08-14
June, 2004 EIR Paul S Ritch, MD - EIR, 2004-06-22
February, 2024 FDA 483 Anita D'Souza, M.D. - Form 483, 2024-02-16
May, 2024 FDA 483 Mehdi Hamadani, M.D - Form 483, 2024-05-23

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