FDA Investigator Bruce H Mccullough

Bruce H Mccullough has inspections in 12 countries as of 02 Oct 2023. Bruce H Mccullough has collaborated with a combinined 7960 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
211
Last Inspection Date:
02 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Japan, Spain, Germany, United Kingdom of Great Britain and Northern Ireland, Italy, Netherlands, Switzerland, Austria, France, Ireland
Co-Investigator(s):
Ademola O Daramola, Alan M Barker, Alan M Roberts, Alecia L Marson, Alicia M Mozzachio, Amanda Dinaro, Amanda E Lewin, PhD, Amanda S Zorn, Ana E Morales, Ana L Kewes, Anastasia M Shields, Anders W Evenson, Andrew A Leboeuf, Andrew J Barrowcliff, Anita Narula, PhD, Anjali Shukla, PhD, Ann Marie Montemurro, Ann Marie Schofield, Anna Flynn, Anthony F Lorenzo, Anthony N Onianwa, April L Young, Arindam Dasgupta, PhD, Ashley L Reiber, Azza Talaat, Barbara Janine Breithaupt, Barbara M Frazier, Barry Cherney, PhD, Bernice F Hirsch, Binh T Nguyen, Bo Chi, PhD, Bradley J Maunder, Brian D Nicholas, Brian D Nicholson, Brian P Emanuel, Brittani N Franklin, Brittany D Terhar, Brittany R Laymon, Bruce M Mccullough, Bruce Mccullough, Bryan L Mcguckin, Burnell M Henry, Carl A Huffman, III, Carla A Norris, Carla J Lundi, Carlyn L Ray, Carrie Ann Plucinski, Caryn M Mcnab, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, Chad E Schmear, Chad J Whitwell, Chad W Rice, Charles A Snipes, PhD, Charles I Ann, Charles L Zhou, Charlie P Booker, Chase S Baldwin, Chery Grandinetti, Cheryl A Kmiec, Chiang Syin, PhD, Chrissy J Cochran, Christina A Miller, Christina Capacci Daniel, PhD, Christina V Santos, Christine W Twohy, Christopher B Harding, Christopher D Leach, Christopher R Czajka, Claire M Minden, Clifton C Francis, Clotia Cabbey Mensah, Constantin Y Philopoulos, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Daniel C Kearns, Daniel Kearns, Dariusz Galezowski, Darrell E Luedtke, David G Eng, David J Gasparovich, David M Beltran, David Perkins, Debra Boyd Seale, Debra I Love, Debra L Boyd Seale, Dell S Moller, Denarvis C Mendenhall, Denise L Burosh, Denise M Digiulio, Dennis Cantellops Paite, Diane L Raccasi, Don H Bark, PhD, Donna Mwilliams Hill, Douglas A Campbell, Dr. Barbara D Paul, PhD, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Zhou Chen (nmi), MD PhD, Eboni S Funderburk, Edmund F Mrak, Jr, Edwardstine J Reese, Edwin Melendez, Elizabeth L Philpy, Elliot P Cowam, PhD, Emilie E Kahn, Enrico Joset Mangahis, Enrico Mangahis, Ephrem Hunde, PhD, Eric M Mueller, PharmD, Eric S Pittman, Farhana Khan, Francis A Guidry, Gajendiran Mahadevan, PhD, Gale E Ryan, Gene D Arcy, Gerald B Seaborn, Jr, Goran Periz, PhD, Greg Brinsley, Gregory R Brinsley, Gregory R Dill, Gwyn G Dickinson, Harperd, Hasan A Irier, PhD, Heika R Tait, Helen B Ricalde, Helen Verdel, Howard Sklamberg, Humera Khan, Humera T Khan, Ivis Lnegron Torres, Jacek Cieslak, PhD, Jacob G Luts, Jacob G Lutz, Jacqueline Mdiaz Albertini, James C Maclaughlin, James D Bridges, James E Roberts, James I Giefer, James L Dunnie, Jr, James P Duggan, James T Karpus, James W Plucinski, Jan B Welch, Jan Welch, Janae D Price, Janet L Bowen, Jason F Chancey, Jeanne Fringer, PhD, Jeanne J Chiu, Jeanne J Thai, Jeanne M Morris, Jeffrey D Meng, Jeffrey M Watson, Jennifer A D'angelo, Jennifer C Adams, Jennifer C Johnson, Jennifer Del Valle, Jennifer L Gustavus, Jennifer Lalama, Jennifer M Gogley, Jeremy W Rotton, Jesse A Vazquez, Jessica Hankins, PhD, Jessica L Burley, Joan A Loreng, Joanne E King, Jocelyn C Turner, Joey V Quitania, John A Gonzalez, John A Podsadowski, John E Verbeten, John M Seale, John Misock, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose M Cayuela, Joseph A Morkunas, Joseph A Piechocki, Joseph D Cooper, Joshua M Adams, Julie D Bringger, Junho Pak, Kalavati Suvarna, PhD, Karen E D'orazio, Karen E Masley, Karen Emasley Joseph, Karen Emaslwey Joseph, Kathleen A Schelble, Kathleen B Swat, Kathleen S Tormey, Kelly I Anderson, Kendra A Biddick, Kent C Faul, Kevin A Gonzales, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kevin P Regan, Kham Phommachanh, Kim Lthomas Cruse, Kimberly Lewandowski Walker, Kristen D Evans, Kristen D Jarell, Kristen E Szenderski, Kristy A Zielny, Kshitij A Patkar, Kujtim Sadiku, Kumar G Janoria, Kyran R Gibson, Lagurta M Mayher, Lakisha M Williams, Lana K Waselewski, Larry F Hallberg, Latoya A Griffith, Laura Fontan, MS, Lauren A Crivellone, Lauren N Howard, Laurie A Haxel, Laurie B Frazier, Laurimer Kuilan Torres, Lawrence J Stringer, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Michael H Tollon, Lequita M Mayhew, Liliya V Bubiy, Lillian M Starr, Liming Zhang, Linda M Cheny, Lindsey S Fleischman, Lisa C Lewis, Lisa Hayka, Lisa Haykay, Lisa Hornback, Lisa M Bellows, Lisa M Feola, Logan M Ebeling, Lorelei S Jarrell, Lori B Wikstrom, Lucas B Leake, Luis M Burgos, Luis M Burgos Medero, Maksim A Levenchuk, Marcia A Worley, Marcus F Yambot, Margaret M Annes, Margaret Mtorres Vazquez, Margaret Torres Vazquez, Maria A Reed, Maria Diaz, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marie Bbuen Bigornia, Mark D Johnson, Mark E Frank, Mark E Parmon, Mark G Peterson, Mark I Kaspar, Mark R Mcclain, Martha T Olone, Martin K Yan, PhD, Marvin D Jones, Matthew B Casale, Matthew J Sienko, Maureen C Melvin, Maya M Davis, Mei Chiung J Huang, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melissa D Ray, Meyer J Slobotsky, Michael A Charles, Michael D Robinson, Michael E Maselli, Michael J Verdi, Michael L Casner, Michael P Sheehan, Michael Shanks, MS, Michael Y Philopoulos, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Micmarie Ramos, Miguel A Martinez, Mihaly S Ligmond, Mra Davism, Mra Mcculloughj, Mra Munizn, Muna Algharibeh, Nancy L Rolli, Natasha R Johnson, Nayan J Patel, Nibin Varghese, MS, Nicholas A Violand, Nicholas F Lyons, Nicholas J Presto, Nicholas L Paulin, Nicholas P Diorio, Nicholas Z Lu, Nicole J Clausen, Nicole K Trudel, Nicole S Williams, Norman K Starks, Norman L Brown, Norman Wong, Omotunde O Osunsanmi, Pablo Alcantara, Paola S Barnett, Parul M Patel, Patricia A Mcilroy, Patricia S Smith, Patrick C Klotzbuecher, Patrick E Gainer, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paul Mouris, Paula A Trost, Paula P Demichael, Peng Zhou, Philip F Istafanos, DMV, MS, Phung Thien Nguyen, Prabhu P Raju, Rachel Novak, PhD, Rachel T Evans, Rafael Nevarez Nieves, Rafael Padilla, Ralph A Erickson, Randy L Self, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard H Penta, Richard K Vogel, Rita K Kabaso, Robert C Coleman, Robert D Tollefsen, Robert J Ham, Robert L Stevenson, Roberta W Cunningham, Rochelle K Kimmel, Rodney G Raiford, Roger F Zabinski, Rona Leblanc, PhD, Rose M Ashley, Rosemary A Sexton, Roshni J Patel, Ross J Grigsby, Ruben C Ayala, PharmD, Russ R Rivy, Russell J Glapion, Russell K Riley, Saied A Asbagh, Salvatore N Randazzo, Samantha J Bradley, Samina S Khan, Sandra A Hughes, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah B Tanksley, Sarah E Mcmullen, Scott A Krause, Scott B Laufenberg, Seneca D Toms, Shafiq S Ahadi, Shalonda C Clifford, Shana L Williams, Shannon A Dinardo, Shawn R Gould, Shirley H Isbill, Sidney B Priesmeyer, Simone E Pitts, Simone Pins, State Agency, Stefen D Mcmillan, Stephen C Mahoney, Stephen D Eich, Stephen R Souza, Steven B Hertz, Steven D Kehoe, Sudha Shukla, Sullan, Susan A Zullo, PhD, Susan D Yuscius, Susan M Jackson, Susan P Bruederle, Susan W Ciani, Susan Yuscius, Susanna E Ford, Analyst, Susant Hadman, Tamara Brey, Tamara M Qtami, Tara C Alcazar, Tara M Carolfi, Ted L Anderson, Temar Q Williams, Tenzin Jangchup, Terri L Dodds, That Q Dang, Thomas A Peter, Thomas J Arista, Thomas W Gordon, Thunder N Dunkijacobs, Thuy T Nguyen, LCDR, Tiffani D Wilson, Todd M Stankewicz, Todd Q Dang, Torrance J Slayton, Torrey M Ward, Travis S Bradley, Uttaniti Limchumroon (Tom), Vaishali J Patel, Veronica Fuentes, MS, Vioela J Caze, Virginia Carroll, PhD, Vlada Matusovsky, Wayne D Stowell, Wayne E Seifert, William D Sherman, William R Weissinger, Xianghong Jing (Emily), PhD, Xiaohui Shen, Xiaokuang Lai, PhD, Yasamin Ameri, Yiyue Zhang (nmi), PhD, Yuanyuan Li, Yvonne E Lozano, Yvonne Lozano, Zachary A Bogorad, Zachary L Stamm, Zhihao Qiu (Peter), PhD, Zhong Li, PhD

Bruce H Mccullough's Documents

Publish Date Document Type Title
July, 2002 FDA 483 Abbott Laboratories - Form 483, 2002-07-24
March, 2000 EIR Larson, Richard A., M.D. - EIR, 2000-03-14
May, 2001 FDA 483 Baxter Healthcare Corporation - Form 483, 2001-05-18
February, 2000 EIR IIT Research Institute - EIR, 2000-02-18
July, 2008 FDA 483 Sage Products LLC - Form 483, 2008-07-10
September, 2010 FDA 483 Grace Analytical Laboratory, Inc - Form 483, 2010-09-23
August, 2001 EIR Sunstar Americas Inc - EIR, 2001-08-06
February, 2004 FDA 483 AbbVie Inc. - Form 483, 2004-02-17
August, 2000 FDA 483 IIT Research Institute - Form 483, 2000-08-17
June, 2011 FDA 483 Hydrox Laboratories - Form 483, 2011-06-08
December, 2001 FDA 483 Rising Pharma Holdings, Inc. - Form 483, 2001-12-17
October, 2012 FDA 483 Raani Corporation - Form 483, 2012-10-30
May, 2001 FDA 483 Response Baxter Healthcare Corporation - Form 483R, 2001-06-07
April, 2001 EIR Catalent Pharma Solutions, LLC - EIR, 2001-04-05
December, 2000 EIR Fresenius Kabi USA, LLC - EIR, 2000-12-14
May, 2000 FDA 483 James R. Herron, M.D. - Form 483, 2000-05-02
May, 2000 EIR Herron, James R. M.D. - EIR, 2000-05-02
March, 2003 EIR SGS North America Inc. - EIR, 2003-03-07
September, 2003 FDA 483 Response AbbVie Inc. - Form 483R, 2003-10-16
December, 2003 EIR Particle Technology Labs - EIR, 2003-12-03
October, 2000 EIR Regis Technologies Inc. - EIR, 2000-10-05
September, 2003 EIR AbbVie Inc. - EIR, 2003-09-26
October, 2006 FDA 483 PharmPro, Division of Fluid Air - Form 483, 2006-10-17
October, 2009 FDA 483 Sage Products LLC - Form 483, 2009-10-01
December, 2000 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2000-12-14
February, 2000 FDA 483 IIT Research Institute - Form 483, 2000-02-18
May, 2002 EIR Baxter Oncology GmbH - EIR, 2002-06-14
June, 2007 EIR Actavis Incorporated - EIR, 2007-06-05
July, 2011 FDA 483 American Blending & Filling Company, Inc. - Form 483, 2011-07-11
May, 2009 FDA 483 Pharmaceutical Laboratories and Consultants, Inc. - Form 483, 2009-05-21
November, 2007 FDA 483 PharmPro, Division of Fluid Air - Form 483, 2007-11-09
January, 2002 EIR Tap Pharmaceutical Products Inc. - EIR, 2002-01-17
March, 2013 FDA 483 Medaus, Inc. - Form 483, 2013-03-22
March, 2001 FDA 483 G.D. Searle & Co. - Form 483, 2001-03-22
November, 2004 EIR Baxter Healthcare Corporation - EIR, 2004-11-17
December, 2000 FDA 483 Response Fresenius Kabi USA, LLC - Form 483R, 2001-01-12
March, 2007 FDA 483 Topical Pharmaceuticals Inc. - Form 483, 2007-03-08
August, 2001 EIR Burnham Laboratories, Inc. - EIR, 2001-08-30
July, 2009 FDA 483 Sage Products LLC - Form 483, 2009-07-23
May, 2002 FDA 483 Response Baxter Oncology GmbH - Form 483R, 2002-08-26
January, 2007 FDA 483 Pharmichem Testing Services - Form 483, 2007-01-30
April, 2013 FDA 483 Finish Line Horse Products Inc. - Form 483, 2013-04-04
April, 2001 EIR Fresenius Kabi USA, LLC - EIR, 2001-04-02
June, 2000 FDA 483 Mylan Institutional Inc. - Form 483, 2000-06-07
June, 2007 FDA 483 Actavis Incorporated - Form 483, 2007-06-05
November, 2011 FDA 483 AmericanAnalytical Chemistry Laboratories Corp. - Form 483, 2011-11-18
May, 2011 FDA 483 Alva-Amco Pharmacal Companies, LLC - Form 483, 2011-05-04
November, 2010 FDA 483 Glaxo Operations UK Ltd - Form 483, 2010-11-01
January, 2008 EIR McCrone Associates, Inc. - EIR, 2008-01-16
March, 2008 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2008-03-18
July, 2008 FDA 483 Abbott Laboratories - Form 483, 2008-07-30
February, 2004 FDA 483 Response AbbVie Inc. - Form 483R, 2004-03-03
January, 2006 FDA 483 American Blending & Filling Company, Inc. - Form 483, 2006-01-10
July, 2003 FDA 483 Apotex Corp. - Form 483, 2003-07-10
August, 2000 EIR IIT Research Institute - EIR, 2000-08-17
May, 2001 EIR Baxter Healthcare Corporation - EIR, 2001-05-18
August, 2010 FDA 483 CPC Laboratories Inc - Form 483, 2010-08-18
March, 2012 FDA 483 CPC Laboratories Inc - Form 483, 2012-03-23
September, 2006 FDA 483 Meda Pharmaceuticals Inc. - Form 483, 2006-09-15
September, 2003 FDA 483 AbbVie Inc. - Form 483, 2003-09-26
February, 2004 EIR AbbVie Inc. - EIR, 2004-02-17
November, 2008 FDA 483 Astellas Pharma US Inc. - Form 483, 2008-11-20
February, 2013 FDA 483 Central Admixture Pharmacy Services Inc. - Form 483, 2013-02-22
May, 2008 FDA 483 Hydrox Laboratories - Form 483, 2008-05-09
July, 2002 EIR Abbott Laboratories - EIR, 2002-07-24
June, 2000 EIR Mylan Institutional Inc. - EIR, 2000-06-07
June, 2007 FDA 483 Response Actavis Incorporated - Form 483R, 2007-07-02
July, 2002 FDA 483 Response Abbott Laboratories - Form 483R, 2002-10-11
June, 2003 EIR Bidachem S.p.a. - EIR, 2003-06-03
August, 2001 FDA 483 Sunstar Americas Inc - Form 483, 2001-08-06
March, 2000 FDA 483 IRB University of Chicago Biological Sciences Division - Form 483, 2000-03-14
April, 2009 FDA 483 Blue Island Phenol LLC - Form 483, 2009-04-02
June, 2000 FDA 483 Response Mylan Institutional Inc. - Form 483R, 2000-07-10
August, 2001 FDA 483 Burnham Laboratories, Inc. - Form 483, 2001-08-30
July, 2006 FDA 483 Accugen Laboratories, Inc. - Form 483, 2006-07-06
November, 2004 FDA 483 Baxter Healthcare Corporation - Form 483, 2004-11-17
November, 2001 EIR Bodycote Testing Group - Polymers - EIR, 2001-11-30
March, 2001 EIR G.D. Searle & Co. - EIR, 2001-03-22
October, 2000 FDA 483 Regis Technologies Inc. - Form 483, 2000-10-05
August, 2001 FDA 483 Response Sunstar Americas Inc - Form 483R, 2001-08-27

Experience Redica System's 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.


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