FDA Investigator Hugh M Mcclure, II

Hugh M Mcclure, II has conducted inspections on 220 sites in 7 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:
220
Last Inspection Date:
24 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100003847
Countries of Inspections:
United States of America, Canada, Mexico, Switzerland, United Kingdom of Great Britain and Northern Ireland, Taiwan, China
FDA Investigators that have inspected at least one site in common with Hugh M Mcclure, II:
Albert F Peacock, PhD, Alec M O'neal, Allison C Hunter, Allison E Sincek, Amber G Wardwell, Ana C Lazo, Andrea A Branche, Andrew I Carr, Andrew J Barrowcliff, Andrew M Barlow, Andrew R Wasko, Andria L Kuhlman, Angela E Glenn, Anna M Brannen, Anthony E Keller, RPh, Arsen Karapetyan, Bailey A Uetrecht, Barbara J Holladay, Barbara J Maulfair, Barbara J White, Barbara Janine Breithaupt, Benjamin J Dastoli, Benton M Ketron, Brian D Rogers, Brian P Hendrickson, Bryce A Hammer, Byungja E Marciante, Candice C Mandera, Carl A Anderson, Carmen Y Fisher, Carol Rivera Lopez, PhD, Cassandra L Winters, Chantae D Mitchell, Charles C Conn, III, Charles M Kerns, BLT DO, Charles R Bonapace, PhD, Chiaochun J Wang, Ching Jeyg Chang, Christian L Witkovskie, Christina L Bigham, Christina N Maurino, Christopher T Middendorf, Claudia Wrzesinski, Clinton D Priestley, Connie P Rezendes, Courtney N Long, Craig P Seaborn, Craig T Rybus, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia F Kleppinger, MD, Cynthia Jim, CSO, Cynthia L Rakestraw, D'arbra R Blankenship, Darren S Morgan, David K Glasgow, David L Chon, David P Moorhead, David P Vanhouten, Dawn C Olenjack, Dawn M Braswell, Dawn M Mccabe, Deborah A Greco, Debra Lboyd Seale, Dell S Moller, Denise L Burosh, Diane L Raccasi, Diane R Mcdaniel, Djamila Harouaka, Donald B Mckechnie, Dorathy M Eischen, Dorothy W Lee, Dr. Abhijit Raha, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Dylan D Yao, MD, PhD, Edmund F Mrak, Jr, Edward R Kay, Elisa A Nickum, Elizabeth Ll Edwards, Ellen P Madigan, Emily A Baldwin, Eric M Silberhorn, Eric Rothschild, Erin L Mcfiren, Erin M Mcdowell, Frederick M Lochner, Gam S Zamil, Geoffrey K Kilili, George A Prager, George C Amedro, George T Allen, Jr, Gilbert J Heidenblut, Grace P Santos, Haley H Seymour, Hanna L Potter, Harlan J Howard, Heather M Bullock, Hector Jcolon Torres, Heika R Bounds, Heika R Tait, Holly J Rapier, Holly J Wilson, Holly M Zahner, Jack Ragheb, Jacqueline A O'shaughnessy, PhD, James P Finn, James W Whitney, Jane M Kreis, Janet L Bowen, Jason D Werne, Javonica F Penn, Jazmine N Still, Jeffrey A Sincek, Jennifer L Huntington, Jennifer L Jager, Jennifer L Sheehan, Jerry J Corwin, Jessica M Wooten, Jianming Li, Joanne M Schlossin, Jodi M Gatica, Joel D Martinez, John A Kadavil, PhD, John Dan, John E Russell, Jr, Jonathan A Ferguson, Joo Jin, Jose Acruz Gonzalez, Joseph W Matthews, Joseph X Kaufman, Joshua C Schafer, Joshua P Wireman, Joshua S Hunt, Julian C Hanson, Julie D Bringger, Justine M Corson, Kalkidan A Molla, Karen L Kosar, Karen M Cooper, Karen M Kondas, Karen Mcnabb Noon, Katherine L Huebner, Kathleen D Culver, Kathryn A Krentz, Kathryn A Nagy, Kathryn J Mccarty, Kathryn Suttling, Keith J Mason, Jr, Kelli L Wilkinson, Kellie L Thommes, RN, Kenneth E Felkley, Kent A Conforti, Kent C Faul, Khoa Nathanv Tran, Kilili Kilili, Geoffrey K, Kimberly A Joseph, Kirk A Dymbrowski, Kristin M Abaonza, Laine P Myers, Lauren E Swantko, Lauren N Howard, Lauren N Smith, Laurie B Frazier, LCDR Angelica M Chica, LCDR Debra Emerson, Leslie R Clark, Linda S Leja, Lindsey M Schwierjohann, Lisa K Capron, Logan T Williams, Lori J Silverstein, Lorie S Hannappel, LT Melanie M Mayor, USPHS, LT Richard A Lyght, Luann Mckinney, Lynnsey A Renn, Marcia A Worley, Maria Pkelly Doggett, MBA, Maribeth G Grattan, Maribeth G Niesen, Marilyn Welchenbach, Mark E Parmon, Marlene L Davis, Martin K Yau, PhD, Mary B Sheets, Mary E Storch, Matt D Suedkamp, Matthew B Casale, Matthew C Watson, Matthew H Pitts, Megan A Haggerty, Michael E Campbell, Michael E Clark, Michael F Skelly, PhD, Michael K Larson, Michael P Sheehan, Michael Serrano, Michelle Yclark Stuart, Mishelle L Harriger, Monique C Lo, Nabil Nakhoul, Nadeem I Chaudhry, Nancy L Neiger, Nicholas L Paulin, Nicole C Victoria, PhD, Nicole M Bell, Noreen Muñiz, Nutan Mytle, Omadevi Somai, Investigator, Omayra Nrodriguez Ruiz, Patrick D Stone, MS, Paul A Bonneau, Paula J Bretz, Peter R Lenahan, Phillip M Pontikos, Pifer, Rafeeq A Habeeb, Rebecca E Cluster, Rebecca Rodriguez, Regina T Brown, Renee S Blosser, Richard H Penta, Richard W Berning, Robert Barron, Robert Rodriguez, Roger F Zabinski, Rosanna M Goodrich, Roy C Stephens, Ruth A Williams, S Lori Brown, PhD MPH, Sally Gopaul, Sam H Haidar, PhD, Samuel A Hamblin, Sarah E Rhoades, Scott B Laufenberg, Sharon L Matson, Sherry L Secrist, BLT DO, Sony Mathews, Srinivas R Chennamaneni, PhD, Stacey A Priest, Stefanie R Cook, Stephanie L Shapley, Stephen J Kilker, Stephen R Souza, Stephen T Hansen, Steven J Libal, Steven P Eastham, Stuart W Russell, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan Kirshner, Susan M Taylor, Susan P Bruederle, Suzanne G Demko, Talmane J Fisher, Tamil Arasu, PhD, Tara K Carmody, Ted L Anderson, Teena H Aiken, Theressa B Smith, Thomas J Arista, Thomas J Prigge, Thomas W Nojek, Thunder N Dunkijacobs, Tracey L Harris, Travis V Hull, Trinidad D Barreras, Tyra S Wisecup, Ucheabuchi Cchudi Nwankwor, Vanessa E Coulter, Vickie J Kanion, Victor Spanioli, Vipulchandra N Dholakia, Wen Ning Chan (Sally), Xikui Chen (nmi), PhD, Yiyue Zhang (nmi), PhD, Yvette Mlacour Davis, Zhigang Sun, PhD

Hugh M Mcclure, II's Documents

Publish Date Document Type Title
March, 2010 EIR James N. Allen, M.d. - EIR, 2010-03-01
July, 2013 EIR Jacques Hebert MD - EIR, 2013-07-19
August, 2000 FDA 483 Hypertension-Nephrology Consultants, Inc. - Form 483, 2000-08-04
September, 2019 EIR Altasciences Preclinical Seattle, LLC - EIR, 2019-09-13
September, 2016 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2016-09-02
May, 2002 EIR Battelle Memorial Institute - EIR, 2002-05-13
May, 2014 FDA 483 Gurcharan S. Syan - Form 483, 2014-05-30
May, 2005 EIR North American Science Associates, LLC - EIR, 2005-05-09
June, 2023 FDA 483 Neuralink Corporation - Form 483, 2023-06-22
February, 2001 EIR Amerisource Inc - EIR, 2001-02-07
March, 2003 FDA 483 Barry S George MD - Form 483, 2003-03-24
November, 2005 FDA 483 Response Manisha H Shah MD - Form 483R, 2005-11-21
April, 2000 FDA 483 Battelle Memorial Institute - Form 483, 2000-04-17
July, 2016 FDA 483 Linfritz Research Institute Inc. - Form 483, 2016-07-22
March, 2013 EIR Burzynski Research Institute - EIR, 2013-03-15
January, 2000 EIR Charles River Laboratories Ashland, LLC - EIR, 2000-01-28
September, 2001 FDA 483 Betco Corporation, Ltd - Form 483, 2001-09-27
August, 2000 EIR John P MacLaurin DO - EIR, 2000-08-04
June, 2004 FDA 483 Dwight A Powell MD - Form 483, 2004-06-08
May, 2002 FDA 483 Response Battelle Memorial Institute - Form 483R, 2002-05-23
March, 2020 FDA 483 Southwest Bio-Labs, Inc. - Form 483, 2020-03-19
August, 2021 FDA 483 Frontage Laboratories, Inc. - Form 483, 2021-08-13
October, 2008 EIR Vivek R Awasty MD - EIR, 2008-10-08
July, 2019 FDA 483 Norbrook Laboratories Limited - Form 483, 2019-07-26
March, 2013 FDA 483 Burzynski Research Institute - Form 483, 2013-03-15
January, 2000 FDA 483 Charles River Laboratories Inc - Form 483, 2000-01-26
May, 2009 FDA 483 Jason A Chesney MD PHD - Form 483, 2009-05-29
October, 2010 EIR Raymond D. Magorien Md - EIR, 2010-10-13
November, 2000 FDA 483 Amscot Medical Laboratories Inc - Form 483, 2000-11-03
December, 2011 FDA 483 Battelle Memorial Institute - Form 483, 2011-12-22
July, 2009 FDA 483 Allergan Sales, LLC - Form 483, 2009-07-10
November, 2005 FDA 483 Manisha H Shah MD - Form 483, 2005-11-08
January, 2005 FDA 483 Daniel L Coury MD - Form 483, 2005-01-26
March, 2013 FDA 483 Stanislaw R Burzynski, MD - Form 483, 2013-03-15
March, 2013 FDA 483 Response Burzynski Research Institute - Form 483R, 2013-04-05
June, 2010 FDA 483 Howard Conter, M.d. - Form 483, 2010-06-25
January, 2000 EIR Charles River Laboratories Inc - EIR, 2000-01-26
April, 2004 FDA 483 Michael Aman PhD - Form 483, 2004-04-26
June, 2000 FDA 483 Remington-Davis Clinical Research - Form 483, 2000-06-21
October, 2016 FDA 483 National Microbiology Laboratory - Form 483, 2016-10-19
June, 2010 FDA 483 Lawrence Komer, M.d. - Form 483, 2010-06-30
May, 2005 FDA 483 North American Science Associates, LLC - Form 483, 2005-05-09
September, 2019 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2019-09-13
October, 2012 EIR Battelle Memorial Institute - EIR, 2012-10-17
October, 2012 FDA 483 Response Battelle Memorial Institute - Form 483R, 2012-10-24
November, 2005 EIR Manisha H Shah MD - EIR, 2005-11-08
June, 2000 EIR Davis Remington Inc - EIR, 2000-06-21
November, 2019 EIR Battelle Memorial Institute - EIR, 2019-11-08
May, 2010 FDA 483 Timothy M Hoffman Md - Form 483, 2010-05-13
December, 2000 FDA 483 Bigmar Pharmaceuticals Inc - Form 483, 2000-12-06
November, 2008 FDA 483 North American Science Associates, LLC - Form 483, 2008-11-14
October, 2010 FDA 483 Raymond D. Magorien Md - Form 483, 2010-10-13
September, 2010 EIR Shelly L Dunmyer MD - EIR, 2010-09-22
April, 2010 FDA 483 Marvin H Thomas Md - Form 483, 2010-04-22
January, 2005 EIR Daniel L Coury MD - EIR, 2005-01-26
July, 2003 FDA 483 Hunt Brothers Products - Form 483, 2003-07-14
June, 2016 FDA 483 Nova Southeastern University IRB #1 - Form 483, 2016-06-16
September, 2003 FDA 483 Charles River Laboratories Inc - Form 483, 2003-09-11
April, 2022 FDA 483 TRS Labs Inc. - Form 483, 2022-04-22
July, 2022 FDA 483 Noble Life Sciences, Inc - Form 483, 2022-07-08
May, 2002 FDA 483 Battelle Memorial Institute - Form 483, 2002-05-13
November, 2012 EIR Sunil Verma, M.D. - EIR, 2012-11-02
November, 2010 FDA 483 Bassel F Shneker MD - Form 483, 2010-11-22
October, 2012 FDA 483 Battelle Memorial Institute - Form 483, 2012-10-17
November, 2012 FDA 483 Sunil Verma, M.D. - Form 483, 2012-11-02
March, 2010 FDA 483 James N. Allen, M.d. - Form 483, 2010-03-01
April, 2004 EIR Michael Aman PhD - EIR, 2004-04-26
March, 2013 EIR Stanislaw R Burzynski, MD - EIR, 2013-03-15
June, 2006 FDA 483 Bernadette D'Souza, MD - Form 483, 2006-06-29
September, 2016 EIR Altasciences Preclinical Seattle, LLC - EIR, 2016-09-02
July, 2017 EIR Abiomed, Inc. - EIR, 2017-07-27
March, 2013 FDA 483 Response Stanislaw R Burzynski, MD - Form 483R, 2013-04-08
April, 2000 EIR Battelle Memorial Institute - EIR, 2000-04-17
July, 2024 FDA 483 Elizabeth Mones, M.D. - Form 483, 2024-07-03
March, 2024 FDA 483 Level Biotechnology Inc. - Form 483, 2024-03-22

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