FDA Investigator Brooke K Higgins

Brooke K Higgins has inspections in 11 countries as of 06 Oct 2023. Brooke K Higgins has collaborated with a combinined 8631 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
223
Last Inspection Date:
06 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Italy, Germany, Ireland, United Kingdom of Great Britain and Northern Ireland, France, Finland, Spain, Netherlands, Mexico
Co-Investigator(s):
Adriana N Jimenez Lopez, Aimee Cunningham, PhD, Alberto A Viciedo, Albinus M D Sa, Alice S Tsao, Alicia M Mozzachio, Alison N Stieg, Allen F Hall, Amber G Chung, Amos C Epps, Amy Devlin, PhD, Amy N Chen, Ana P Pineda Zavaleta, Anastasia G Lolas, Anastasia I Onuorah, Anastasia M Shields, Andrea Siegel, PhD, Angela E Glenn, Anjali Shukla, PhD, Anna Lazar, Annet R Rajan, Anthony F Lorenzo, Anthony W Lee, Arie C Menachem, Arindam Dasgupta, PhD, Asamoah Asamoah, Ashar P Parikh, Atul J Agrawal, Azza Talaat, Barbara A Gullick, Barbara J Holladay, Benjamin J Smith, Bijoy Panicher, Bijoy Panicker, Billingsley, Bo Chi, PhD, Brandon L Mariner, Brenda W Uratani, PhD, Brian L Belz, Brian R Yaun, Brian R Yuan, Brooke K Secman, Brooke K Seeman, Bruce C Kovak, Burnell M Henry, Camerson E Moore, Candice C Mandera, Candice C Mandero, Candice J Cortes, Carla A Norris, Carol Mrivera Lopez, PhD, Carol Rivera Lopez, PhD, Carole L Jones, Caroline Strasinger, Carrie L Doupnik, Caryn M Mcnab, CDR Ileana Barreto Pettit, Cecil D Mitchell, Chaltu N Wakijra, Charlean R Butler, Charles D Boison, Charles R Cote, RIC, Cheryl A Clausen, Cheryl Llove Harris, Chiang Syin, PhD, Chris A Sack, Christian D Lynch (CDL), Christina K Theodorou, Christine W Twohy, Christopher L Taste, Christopher R Richardson, Chryste D Best, Claire M Minden, Clarice J Ahn, Clinton J Lott, Cody D Rickman, Colleen F Hoyt, Colleen Thomas, PhD, Collins M Mason, Concepcion Cruz, Jr, Conrad M Guardia, Craig A Garmendia, Cynthia A Harris, MD, RN, Cynthia T Cain, Daniel R Azar, David A Oluwo, David J Gomes, David L Chon, Deborah J Parris, Dell S Moller, Demitria J Xiradakis, Dennis Cantellops Paite, Dennis L Doupnik, Derek S Smith, PhD, Deyaa Shaheen, Dhaval H Patel, Diane L Raccasi, Diane T Bargo, Diane T O'bien, Diane T O'brien, Dianne H Milazzo, Dianne S Alexander, Dirk L Lincoln, Djamila Harouaka, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Donald L Lech, Douglas A Campbell, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Carmelo Rosa, Dr. Dominick Roselle, Dr. Gang Wang, PhD, Dr. Gopa Biswas, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Sriram Subramaniam, PhD, Dr. Yubing Tang, Edmund F Mrak, Jr, Edward P Potter, Edwin Melendez, Eileen A Liu, Elise A Murphy, Elizabeth Ll Edwards, Elvis D Morton, Emest F Bizjak, Emily Leongini, Emmanuel A Dimaano, Jr, Ephrem Hunde, PhD, Eric L Dong, BS, Erik W Koester, Erin L Mcfiren, Erk W Koester, Ernest P Bizjak, Esaw, Fabian Chaparro, Fabian Nchaparro Rodriguez, Felix Maldonado, Frances Namuswe, PhD, Frank W Perrella, Gale L Glinecki, Gayle S Lawson, Geneve M Maxwell, Geneve M Parks, George Pyramides, Gerald B Seaborn, Jr, Gerald D Bromley, Jr, Gerald Mierle, Gerardo Z Vazquez, Gifford Whitehurst, Jr, Gopa Bisivas, Guerlain Ulysse, Gwyn G Dickinson, Haijing Hu, Hamilton, Haoheng Yan, PhD, Heath A Gerber, Hector J Colon Torres, Helen B Ricalde, Hongna Wang, Howard Anderson, PhD, Huixia Zhang, Jackie O'shaughnessy, Jacqueline A O'shanghnessy, PhD, Jacqueline A O'shaughnessy, PhD, Jacqueline Johnson, Jacqueline Mdiaz Albertini, Jacqueline N O'shaughnessy, Jai P Singh, James C Maclaughlin, James M Mason, James M Simpson, James Norman, James P Mcreavey, James W Leonette, Jamie D Richardson, Janet A Rajan, Jaqueline A O'shaughnessy, Jason D Tenney, Jazmine N Still, Jean Blackston Hill, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jennifer Swisher, PhD, Jensel L Guadalupe, Jesse P Hardin, Jessica Hankins, PhD, Jessica L Pressley, Jessica P Mcalister, Jingbo Xiao, Joanne E King, Joey C West, Jogy George, John A Kadavil, PhD, John D White, John Dan, John M Gusto, John P Mistler, Johnna L Bleem, Johnson, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan W Chapman, Jorge L Gonzalez, Jorge L Guadalupe, Jose Alopez Rubet, Jose M Cayuela, Jose R Hernandez, Joseph L Despins, PhD, Joseph W Matthews, Joshua P Wireman, Juan Rjimenez Garcia, Junho Pak, Justin A Boyd, Justin A Hefferman, Kalavati Suvarna, PhD, Karen A Briggs, Karen A Spencer, Katelyn Astaub Zamperini, Kathleen M Jordan, Kathy Lee, Keith M Reilly, Kellia N Hicks, Kelly L Anderson, Kenneth Gordon, Kenneth H Williams, Kenneth L Smalls, Kenneth M Gordon, Kenneth Nieves, Ko U Min, Kristina L Conroy, Kshitij A Patkar, Kyle S Hobson, La Tasha M Gunter, Lakisha M Williams, Lakshmi Narasimhan, PhD, Lanaire J Cortes, Larry K Austin, Latorie S Jones, Latoya Oliver Powell, Latoya S Oliver Powell, Laurianne M Montonye, Laurimer Kuilan Torres, Laurissa S Flowers, Lawrence Harmon, Jr, Lawrence J Stringer, LCDR Anastasia Mpiliafas Brown, LCDR Debra Emerson, LCDR Wilfred A Darang, Li Lu, PhD, Liatte Kreuger, PharmD, Linda F Murphy, Linda J Eason, Linda L Ng, Lisa B Orr, Lori A Holmquist, Lori A Holquist, Lori S Lawless, LT Luis O Rodriguez, LT Richard A Lyght, Luella J Rossi, Luis A Dasta, Luis Dosta, Luis M Burgos Medero, Lynette P Salisbury, Madushini Dharmasena, PhD, Malgorzata G Norton, Marc S Neubauer, Marcellinus D Dordunoo, Marcia D Fields, Marcus A Ray, Margaret H Waters, Margaret M Annes, Margaret M Doherty, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marie F Morin, Marion Michaelis, Marion W Nadeau, Marisol Faberlle, Martin K Yau, PhD, Mary E Farbman, PhD, Mary K Leslie, Massoud Motamed, Mathew R Manen, Matthew M Henciak, Matthew R Mcnew, Meisha R Sampson, Meisha Waters, Melissa J Garcia, Melissa T Roy, Merideth K Rose, Michael A Taylor, Michael F Skelly, PhD, Michael G Truchan, Michael J Vardon, Michael L Casner, Michael Shanks, MS, Michele L Forster, PhD, Michelle Marsh, Mihaly S Ligmond, Mindy M Chou, Mohamad A Chahine, Monique Rac Lester, Mra Digiuliod, Mra Mcculloughj, Nadeem I Chaudhry, Nancy G Schmidt, Nancy L Meade, Nancy M Espinal, Nathaniel R Esaw, Nawab A Siddiqui, Nebil A Oumer, Nerizza B Guerin, Nicholas A Violand, Nicole K Trudel, Nina Yang, Normica G Facey, Olaide Akinmade, Omotunde O Osunsanmi, Pal S Mayasandra, Paraluman S Leonin, Parul M Patel, Parul Patel Sullivan, Patricia A Morrow, Patricia D Stahnke, Patricia Fhughes Troost, Patrick C Klotzbuecher, Paul L Figarole, Jr, Paula J Bretz, Pelekakis, Prabhu P Raju, Pratik S Upadhyay, DDC, Qiang Gui, Qin Xu, Quyen T Tran, Rabin N Ghoshal, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Raymond W Niles, Reba A Gates, Rebecca E Dombrowski, Rebecca Rodriguez, Regina Gibson Melton, Regina T Brown, Renisha M Shaw, Richard H Penta, Richard Ledwidge (nmi), PhD, Richard W Thornton, Rina Bhikha, Robert C Horu, PhD, Robert H Wittorf, Robert J Ham, Robert J Maffei, Robert J Martin, Robert M Barbosa, Robin Levis, PhD, Rodney G Raiford, Ronald T Nowalk, Rosanna M Goodrich, Rose M Ashley, Roseline N Boateng, Roy R Rinc, Ruark Lanham, Russell J Glapion, Saleem A Akhtar, Sam H Haidar, PhD, Sam Pepe, Samina S Khan, Samuel H Chan, PharmD, Sanket N Patel, Santos E Camara, Sarah E Mcmullen, Satheesh Thomas, Scott R Nichols, PhD, Scott T Panagiotis, Sean R Marcsisin, Sean R Moynihan, MPH, Sean Y Kassim, PhD, Seema S Singh, Sena G Dissmeyer, Shadia Zaman, PhD, Sharon K Thoma, PharmD, Sherry I Seerist, Sherry L Secrist, BLT DO, Shirshendu K Deb, PhD, Shusheen A Alexander, Sierra M Shockley, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Slatten, Sneha Patel, Sneha S Patel, Srinivas R Chennamaneni, PhD, Stacey A Priest, Stacie A Woods, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen C Eason, Stephen D Brown, Steven C Madzo, Steven E Bowen, PhD, Steven J Thurber, Steven Kozlowski, MD, Steven P Donald, Susan J Essenmacher, Susan M Jackson, Susan O Oladeji, Susan P Bruederle, Susanna E Ford, Analyst, Susant Hadman, Suzanne M Healy, Suzanne M Muchene, Swati Verma, Sylvia R Dooling, Tajah L Blackburn, Tamal K Chakraborti, PhD, Tamara L Ely, Tamara N Champion, Tamika White, Tamil Arasu, PhD, Tammara A Stephens, Tania E Vizcaino, Temar Q Williams, Thai D Truong, Theresa M Smedley, Thomas, Thomas E Friel, Thomas J Arista, Thomas J Hudson, Thomas R Withers, Thuy T Nguyen, LCDR, Thuy Y Nguyen, Tiffani D Wilson, Tiki J Dixon, Tonia F Bernard, Torrance J Slayton, Toyin B Oladimeji, Truong Xuan Nguyen (Andy), Vesna V Stanoyevitch, Vilmary Negron Rodriguez, Vipulchandr N Dholakia, Viviana Matta, Vivin George, Walden H Lee, Walter Fava, Walter L Fava, Wanda Y Fields, Wanda Y Honeyblue, Wayne L Jefferson, William A Warnick, William H Linkroum, William J Leonard, William L Bargo, Xiandong Meng, Xiaoshi Wang, Xikui Chen (nmi), PhD, Xu Michael Di, PhD, Yan Qin, Yasamin Ameri, Yih Chain Huang, PhD, Yiyue Zhang (nmi), PhD, Yumi J Hiramine, Yvins Dezan, Yvonne C Mcknight, Zhao Wang, PhD, Zhenzhen Liu, PhD, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu

Brooke K Higgins's Documents

Publish Date Document Type Title
March, 2008 FDA 483 Fareva Richmond, Inc. - Form 483, 2008-03-13
May, 2011 EIR Pharmaceutics International, Inc. - EIR, 2011-05-25
September, 2013 EIR Merck Sharp & Dohme LLC - EIR, 2013-09-30
August, 2012 EIR Merck Sharp & Dohme LLC - EIR, 2012-08-24
April, 2014 EIR Cangene BioPharma, LLC - EIR, 2014-04-09
September, 2004 EIR Boehringer Ingelheim Chemicals, Inc. - EIR, 2004-09-13
May, 2013 EIR United Therapeutics Corporation - EIR, 2013-05-29
May, 2015 FDA 483 NIH Clinical Center Pharmacy Department - Form 483, 2015-05-29
April, 2014 FDA 483 Cangene BioPharma, LLC - Form 483, 2014-04-09
June, 2007 EIR Actavis Mid-Atlantic, LLC. - EIR, 2007-06-22
April, 2012 EIR Boehringer Ingelheim Chemicals, Inc. - EIR, 2012-04-04
August, 2012 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2012-08-24
January, 2011 FDA 483 Bell-More Labs Inc - Form 483, 2011-01-26
July, 2011 FDA 483 Cangene BioPharma, LLC - Form 483, 2011-07-22
June, 2013 EIR Afton Scientific, LLC - EIR, 2013-06-24
March, 2014 EIR Mylan Pharmaceuticals Inc. - EIR, 2014-03-21
March, 2004 FDA 483 Virginia Commonwealth University - Form 483, 2004-03-03
December, 2012 EIR Orion Corporation - EIR, 2012-12-20
July, 2003 EIR Fareva Richmond, Inc. - EIR, 2003-07-18
February, 2013 FDA 483 SOFIE Co. dba SOFIE - Form 483, 2013-02-01
March, 2005 FDA 483 Fareva Richmond, Inc. - Form 483, 2005-03-31
April, 2008 FDA 483 Bell-More Labs Inc - Form 483, 2008-04-23
February, 2012 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2012-02-07
February, 2010 FDA 483 ChemPacific Corporation - Form 483, 2010-02-17
September, 2006 FDA 483 Boehringer Ingelheim Chemicals, Inc. - Form 483, 2006-09-15
May, 2011 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2011-05-12
February, 2009 FDA 483 Fareva Richmond, Inc. - Form 483, 2009-02-27
February, 2008 FDA 483 Neilgen Pharmaceutical Inc Dba Unigen Pharmaceuticals - Form 483, 2008-02-15
December, 2004 FDA 483 Patient First Corporation - Form 483, 2004-12-09
February, 2013 EIR PETNET SOLUTIONS, INC. - EIR, 2013-02-19
March, 2007 FDA 483 Neilgen Pharmaceutical Inc Dba Unigen Pharmaceuticals - Form 483, 2007-03-22
February, 2012 EIR Reckitt Benckiser Pharmaceuticals Inc - EIR, 2012-02-15
June, 2005 EIR Total Homecare Inc. - EIR, 2005-06-06
April, 2012 FDA 483 Boehringer Ingelheim Chemicals, Inc. - Form 483, 2012-04-04
August, 2013 EIR Barr Laboratories Inc. - EIR, 2013-08-23
October, 2012 FDA 483 AG Essence Inc - Form 483, 2012-10-16
April, 2014 FDA 483 Afton Scientific, LLC - Form 483, 2014-04-25
February, 2005 FDA 483 East Coast Oxygen & Hydro Testing Inc. - Form 483, 2005-02-18
May, 2010 FDA 483 Fareva Richmond, Inc. - Form 483, 2010-05-14
December, 2012 FDA 483 Orion Corporation - Form 483, 2012-12-20
July, 2013 FDA 483 Bell-More Labs Inc - Form 483, 2013-07-25
April, 2013 EIR Teva Biopharmaceuticals USA - EIR, 2013-04-17
August, 2013 FDA 483 Barr Laboratories Inc. - Form 483, 2013-08-23
June, 2008 FDA 483 Actavis Mid Atlantic LLC - Form 483, 2008-06-27
March, 2006 FDA 483 Cangene BioPharma, LLC - Form 483, 2006-03-31
May, 2013 FDA 483 United Therapeutics Corporation - Form 483, 2013-05-29
September, 2002 EIR Union Carbide Corporation, Subsidiary of Dow Chemical Compan - EIR, 2002-09-24
June, 2004 FDA 483 DanChem Technologies Inc - Form 483, 2004-06-23
December, 2006 EIR F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. - EIR, 2006-12-13
March, 2011 FDA 483 Carilion Materials Management - Form 483, 2011-03-02
August, 2005 FDA 483 Exelead, Inc. - Form 483, 2005-08-19
August, 2006 FDA 483 Bell-More Labs Inc - Form 483, 2006-08-17
March, 2014 FDA 483 Fareva Richmond, Inc. - Form 483, 2014-03-07
September, 2011 FDA 483 Afton Scientific, LLC - Form 483, 2011-09-26
June, 2008 FDA 483 Response Actavis Mid Atlantic LLC - Form 483R, 2008-07-30
May, 2009 FDA 483 Boehringer Ingelheim Chemicals, Inc. - Form 483, 2009-05-13
August, 2012 FDA 483 Response Merck Sharp & Dohme LLC - Form 483R, 2012-09-10
January, 2004 EIR Reckitt Benckiser Pharmaceuticals Inc - EIR, 2004-01-23
March, 2014 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2014-03-21
June, 2013 FDA 483 Afton Scientific, LLC - Form 483, 2013-06-24
July, 2012 EIR Barr Laboratories Inc. - EIR, 2012-07-26
May, 2013 FDA 483 Fareva Richmond, Inc. - Form 483, 2013-05-30
October, 2004 FDA 483 DanChem Technologies Inc - Form 483, 2004-10-05
May, 2011 FDA 483 Pharmaceutics International, Inc. - Form 483, 2011-05-25
August, 2011 FDA 483 Barr Laboratories Inc. - Form 483, 2011-08-25
December, 2010 FDA 483 Pharmaceutics International, Inc. - Form 483, 2010-12-16
August, 2005 EIR Exelead, Inc. - EIR, 2005-08-19
October, 2004 FDA 483 Fareva Richmond, Inc. - Form 483, 2004-10-08
October, 2009 FDA 483 Jubilant Cadista Pharmaceuticals Inc. - Form 483, 2009-10-29
March, 2013 FDA 483 Olympia Compounding Pharmacy dba Olympia Pharmacy - Form 483, 2013-03-21
October, 2009 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2009-10-01
February, 2014 FDA 483 RX South DBA RX3 Compounding Pharmacy LLC - Form 483, 2014-02-21
August, 2010 FDA 483 Cangene BioPharma, LLC - Form 483, 2010-08-27
June, 2004 FDA 483 Atley Pharmaceuticals, Inc. - Form 483, 2004-06-24
June, 2003 EIR Mylan Pharmaceuticals Inc. - EIR, 2003-06-17
June, 2012 FDA 483 Pharmaceutics International, Inc. - Form 483, 2012-06-01
June, 2005 FDA 483 Total Homecare Inc. - Form 483, 2005-06-06
February, 2006 FDA 483 Actavis Mid-Atlantic, LLC. - Form 483, 2006-02-17
February, 2013 EIR IBA Molecular North America Inc. - EIR, 2013-02-01
July, 2010 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2010-07-09
September, 2006 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2006-09-29
June, 2005 FDA 483 Response Total Homecare Inc. - Form 483R, 2005-06-10
September, 2013 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2013-09-30
September, 2004 FDA 483 Boehringer Ingelheim Chemicals, Inc. - Form 483, 2004-09-13
October, 2007 FDA 483 Afton Scientific, LLC - Form 483, 2007-10-23
April, 2010 FDA 483 Barr Laboratories Inc. - Form 483, 2010-04-08
October, 2004 FDA 483 Biovail Technologies Ltd. - Form 483, 2004-10-29
August, 2005 FDA 483 Response Exelead, Inc. - Form 483R, 2005-09-15

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.

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