FDA Investigator Barbara Janine Breithaupt

Barbara Janine Breithaupt has inspections in 16 countries as of 30 Aug 2023. Barbara Janine Breithaupt has collaborated with a combinined 9007 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
176
Last Inspection Date:
30 Aug 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
Country:
United States of America, Thailand, Australia, Sweden, India, Switzerland, Netherlands, New Zealand, Canada, Germany, South Africa, Taiwan, Austria, Poland, Ireland, China
Co-Investigator(s):
Adam R Cooke, Adetutu M Gidado, Adree N Anderson, Adrienne Morgan, Alan P Kurtzberg, Alanna Lmussawwir Bias, Alexander M Kay, Alia Legaux, Alicia M Frees, Allen F Hall, Allison V Bonnenburg, Alysia C Alger, Amanda E Lewin, PhD, Andrace Lde Yampert, Andrea A Branche, Andrew "Drew" Haack, PhD, Andrew A Hoopes, Andrew Haack, PhD, Andrew K Haack, PhD, Andrew Le, Andrew R Wasko, Angela E Glenn, Anita Narula, PhD, Anita R Michael, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Annette L Diggs, Aqualia L Nelson, Ashar P Parikh, Astrida B Mattson, Azza Talaat, Babatunde Ojo, Barbar J Breithaupt, Barbara J Holladay, Barbara M Frazier, Bo Chi, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandi E Williams, Brenda W Uratani, PhD, Brent T Hall, Brett R Havranek, Brian Church, Brian Janelsins, PhD, Brittany D Phillips, Brittany D Terhar, Bruce E Taylor, Bruce H Mccullough, Byungja E Marciante, Candace S Tucker, Carl A Anderson, Carl A Huffman, III, Carl J Montgomery, Carla A Norris, Carla J Lundi, Carmen Y Fisher, Caryn M Mcnab, CDR Donald Ertel, CDR Ileana Barreto Pettit, Chaltu N Wakijra, Charles M Edwards, Charles R Bonapace, PhD, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Chava Kimchi Sarfaty, PhD, Chen Sun, PhD, Chris A Sack, Christian D Lynch (CDL), Christine A Harman, PhD, Christine M Smith, Christine Mwhitby Smith, Christopher D Snyder, Christopher R Czajka, Christopher S Keating, Clifford F Long, Cody J Alley, Collins M Mason, Conner N Mann, Connie P Rezendes, Connie P Rezenes, Courtney N Long, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia M Goudeau, Da Lin Yao, MD, PhD, Dana D Carter, SR DDS, Dana M Klimavicz, Dandan Wang, PhD, Daniel J Lahar, Daniel J Roberts, Daniel L Aisen, Daniel R Azar, Darla J Christopher, Darrah, Darren S Brown, David G Eng, David J Daworski, David L Miser, David M Beltran, Dawn C Olenjack, Dawn E Barkans, Dawn L Wydner, Deborah A Greco, Deborah L Wade, Deborah M Trout, Debra Bower, Dennis Cantellops Paite, Diana K Krepel, Diane T Wade, MS, Dina K West, Dina Kloost, Djamila Harouaka, Dolores E Price, Don A Brunssen, Don H Bark, PhD, Donald B Mckechnie, Donald C Obenhuber, PhD, Donald W Jehn, Dongping Dai, PhD, Douglas A Campbell, Dr. Chunchang Fang, Dr. Gopa Biswas, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Edmund F Mrak, Jr, Edward E Lockwood (EEL), Edwin Martinez, Edwin Melendez, Eileen A Liu, Elizabeth D Connell, Emest F Bizjak, Eric C Nielsen, Eric L Dong, BS, Eric M Mueller, PharmD, Eric S Weilage, Eric T Huebler, Erika V Butler, Erin L Mcfiren, Erin M Mcdowell, Esaw, Esteban Beltran, Esther A Ofori, Farhana Khan, Gary C Pecic, Gene D Arcy, George G Calafactor, Gerald B Seaborn, Jr, Gerard Pde Leon, Ginger M Sykes, Gloria J Baca, MS, Grace P Santos, Gretchen Lf Trendel, Gwyn G Dickinson, Hala L Selby, Hanisol Fabenelle, Heath W Cartwright, Heika R Bounds, Heika R Tait, Heika Tait, Hugh M Mcclure, II, Iris C Macinnes, Ismael Olvera, IV, Jacek Cieslak, PhD, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, James A Lane, James D Bridges, James D Planchon, James I Giefer, James J Houlihan, James L Dunnie, Jr, James S Stuart, BS, Jane M Kreis, Janesa A Licorish, Janete A Eaker, Janete A Oliveira, Janete F Guardia, Jeffery A Hangartner, Jeffrey P Raimondi, Jen Sui, Jennifer C Adams, Jennifer L Bridgewater, Jennifer S Ness, Joan A Loreng, Joan Johnson, Joanne E King, Joey C West, Joey V Quitania, John A Iwen, John M Gusto, Johnson, Johnsont, Jonathan W Chapman, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Joselin P Baray Alvarado, Joseph R Lambert, Joshua P Wireman, Juanita P Versace, Julian C Hanson, Julie D Bringger, Junho Pak, Jyoti B Patel, PhD, Kalavati Suvarna, PhD, Kamara Mo, Karen C Daugherty, Karen E D'orazio, Karen M Montgomery (KMM), Kari M Johansen, Katherine M Taylor, Katherine Szestypalow, Kathleen B Swat, Kathleen J Close, Kathleen R Jones, PhD, Kathryn A Krentz, Kathryn E King, Kejun Cheng, Kellia N Hicks, Kellie L Thommes, RN, Kenneth Nieves, Kenneth O Gee, PhD, Kevin A Beavers, Kevin A Gonzalez, Kevin D Kallander, Kevin E Klommhaus, Kevin P Foley, Kham Phommachanh, Kimberley A Hoefen, Krishna Ghosh, PhD, Kristen D Evans, Kristi B Panzer, Kristin M Abaonza, Kristopher J Stanya, PhD, Kurt A Brorson, PhD, Lakisha M Williams, Larry K Austin, Laurel A Beer, Lauren E Swantko, Laurie A Haxel, Laverne Puckett, Lawrence J Stringer, Lawrence Y Lee, PhD, LCDR Debra Emerson, Lesley A Swanson, Li Hongpaul Yeh, PhD, Linan Ha, PhD, Linda K Cline, Linda R Kuchenthal, Linda S Leja, Linda Thai, Linhart, Lionell L Thomas, Lisa K Capron, Lisa L Flores, Lisa P Oakes, Lisa T Michel, Lori A Gioia, Lori J Silverstein, Luis M Burgos Medero, Lynda L Perry, PhD, Lynette P Salisbury, Mai X Huynh, Makini Cobourne Duval, PhD, Marci M Deleon, Margaret M Annes, Maria A Ruttell, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Maria Pkelly Doggett, MBA, Maridalia Torres Irizarry, Marie Bbuen Bigornia, Marie F Morin, Marijo B Kambere, PhD, Marilyn M White, Marion W Nadeau, Marisol Faberlle, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark W Babbitt, Marlene G Swider, Marquessa M Rowe, Martin K Yan, PhD, Martin K Yau, PhD, Martin Yan, Marvin D Jones, Mary E Farbman, PhD, Mary K Concannon, Mathur, Matthew B Casale, Maxine H Wong, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melinda L Rice, Melissa J Garcia, Michael A Charles, Michael A Feingold, Michael E Maselli, Michael F Skelly, PhD, Michael J Verdi, Michael P Sheehan, Michael R Goga, Michael S Araneta, Michael Shanks, MS, Michele L Obert, Michele Perry Williams, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Mikel T Wright, Mikhail V Ovanesov, PhD, Mindy M Chou, Minerva Rogers, Mohsen Rajabi Abhari, FDA, Monica Cburgos Garcia, Mra B Kamberem, Mra Mcculloughj, Muralidhara B Gavini, PhD, Namcy E Byerly, Nancy A Bellamy, Nancy A Saxenian Emmons, Nancy E Byerly, Nancy G Schmidt, Nataniel Phillips Sylvain, PhD, Nathan R Moon, Nebil A Oumer, Ngoc B Kelsch, Nia K Walker, Nicholas L Paulin, Nicola M Fenty Stewart, Nilufer M Tampal, PhD, Nilufer M Tampalm, PhD, Norman K Starks, Omotunde O Osunsanmi, Pal S Mayasandra, Parul M Patel, Patrick C Klotzbuecher, Patrick J Lynch, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul P Geraci, Paula A Trost, Paula J Bretz, Peter Abel, Peter C Chow, Peter E Gruman, Philip F Istafanos, DMV, MS, Philip J Snoy, Ponzoj, Prabhu P Raju, Qin Xu, Rabia Ballica, PhD, Rachel C Harrington, Ralph Jerndal, Randy L Self, Rashonda N Rucker, Raymond T Oji, Rebecca E Dombrowski, Rebecca Rodriguez, Reyes Candau Chacon, PhD, Richard E Needham, Richard Heath Coats, Richard J Friedman, Richard Jay Tucker, RS, Richard K Vogel, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Riley Meyers, Rita K Kabaso, Robert D Tollefsen, Robert J Waldorf, Robert L Hummel, Rochelle K Kimmel, Rodney D Combs, Rodney G Raiford, Roger F Zabinski, Ronald G Crawford, Rose M Ashley, Rose Xu, Russell J Glapion, Ryan S Martin, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santos E Camara, Sarah E Mcmullen, Sarah E Rhoades, Sarah Forney, Sarah Ibrahim, Satheesh Thomas, Scot M Stodola, Scott A Jepson, Scott B Laufenberg, Scott Platt, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Seneca D Toms, Sergio Chavez (NMI), Shanna R Ausfahl, Shanna R Haden, Sharon K Thoma, PharmD, Shaun M Olson, Shawn B Johnson, Sherri N Rohlf, MD, Sherry L Secrist, BLT DO, Shirley J Berryman, Shuen G Chai, Simone E Pitts, Sneha S Patel, Soyinka S Eneng, Spiram Subramaniam, PhD, Sripal R Mada, PhD, Sriram Susrambraham, State Agency, Stephanie L Shapley, Stephen D Eich, Steven A Gonzales, Steven C Clifford, Steven C Madzo, Steven D Kehoe, Steven Fong, MS, PhD, Steven M Weinman, Steven P Allen, Steven P Donald, Steven W Brown, Steven Wienman, Stroman, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan M Jackson, Susanna E Ford, Analyst, Susant Hadman, Tamara N Champion, Tara G Bizjak, Tara L Greene, Tara L King, Tawny L Colling, Teegan Dellibovi Ragheb, PhD, Terri L Dodds, Terry L Dodds, Theressa B Smith, Thomas, Thomas J Arista, Thora W Whitmore, Thuy T Nguyen, LCDR, Tiffani D Wilson, Tiki J Dixon, Tina S Roecklein, Torrance J Slayton, Torrey M Ward, Toyin B Oladimeji, Tracy K Li, Tristian E Strait, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), V Teres Speer, Vaishali J Patel, Valshall Patel, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Vickie J Kanion, Victoria L Palmer, Vilmary Negron Rodriguez, Walden H Lee, Walsworth, Wanda B Coats, Wayne D Mcgrath, Wayne E Seifert, Wayne T Smith, Wendy G Tan, PhD, Xianghong Jing (Emily), PhD, Xikui Chen (nmi), PhD, Xiomara Copeland, Yideng Liang, Yong Hu, Yuan Chia Kuo, Yumi J Hiramine, Zachary A Bogorad, Zhong Li, PhD, Zhongren Wu

Barbara Janine Breithaupt's Documents

Publish Date Document Type Title
March, 2013 FDA 483 Response SEAGEN INC. - Form 483R, 2013-04-08
September, 2008 FDA 483 Bioreliance Corporation - Form 483, 2008-09-29
May, 2007 EIR University of Iowa Pharmaceuticals - EIR, 2007-05-01
December, 2002 EIR APC Co Inc - EIR, 2002-12-23
May, 2007 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2007-05-01
April, 2003 FDA 483 Madison County Medical Equipment Incorporated - Form 483, 2003-04-10
April, 2009 FDA 483 Cardinal Health 414, LLC - Form 483, 2009-04-17
May, 2009 FDA 483 Jubilant HollisterStier LLC - Form 483, 2009-05-08
April, 2014 FDA 483 Jubilant HollisterStier LLC - Form 483, 2014-04-15
May, 2010 FDA 483 Advanced Medical Isotope Corporation - Form 483, 2010-05-07
June, 2012 EIR Genentech, Inc. - EIR, 2012-06-27
March, 2013 FDA 483 SEAGEN INC. - Form 483, 2013-03-20
August, 2013 FDA 483 Nang Kuang Pharmaceutical Co. Ltd. - Form 483, 2013-08-30
November, 2013 EIR Cardinal Health 414, LLC - EIR, 2013-11-08
February, 2009 FDA 483 Melaleuca - Form 483, 2009-02-06
December, 2004 FDA 483 Weeks & Leo Co., Inc. - Form 483, 2004-12-06
May, 2010 FDA 483 Jubilant HollisterStier LLC - Form 483, 2010-05-28
March, 2015 FDA 483 Partner Therapeutics, Inc. - Form 483, 2015-03-18
September, 2011 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2011-09-27
November, 2009 EIR Altasciences Preclinical Seattle, LLC - EIR, 2009-11-20
September, 2014 FDA 483 Sandoz GmbH - Form 483, 2014-09-16
November, 2010 FDA 483 Melaleuca - Form 483, 2010-11-03
May, 2021 FDA 483 Genentech, Inc. - Form 483, 2021-05-21
November, 2013 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2013-11-22
March, 2009 FDA 483 Jubilant HollisterStier LLC - Form 483, 2009-03-26
December, 2012 FDA 483 Cardinal Health 414, LLC - Form 483, 2012-12-14
May, 2021 EIR Genentech, Inc. - EIR, 2021-05-21
October, 2009 FDA 483 Response Omega Tech Labs Inc - Form 483R, 2009-10-20
November, 2014 FDA 483 Response Galena Biopharma, Inc. - Form 483R, 2014-12-11
February, 2014 FDA 483 Holopack Verpackungstechnik GmbH - Form 483, 2014-02-14
June, 2012 FDA 483 Genentech, Inc. - Form 483, 2012-06-27
April, 2011 EIR Sun Pharmaceutical Industries Limited - EIR, 2011-04-07
November, 2009 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2009-11-20
July, 2013 FDA 483 University of Washington PET Radiochemistry Laboratory - Form 483, 2013-07-18
March, 2011 EIR BASi Northwest Laboratory - EIR, 2011-03-04
April, 2012 EIR AGC Biologics, Inc. - EIR, 2012-04-18
February, 2012 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2012-02-07
September, 2008 EIR Bioreliance Corporation - EIR, 2008-09-29
November, 2013 FDA 483 Response Cardinal Health 414, LLC - Form 483R, 2013-12-10
February, 2014 FDA 483 Holopack-Verpackungstechnik-GmbH - Form 483, 2014-02-14
August, 2012 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2012-08-08
October, 2009 FDA 483 Partner Therapeutics, Inc. - Form 483, 2009-10-28
May, 2015 FDA 483 Montana Compounding Pharmacy PC - Form 483, 2015-05-08
December, 2010 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2010-12-03
November, 2013 FDA 483 Cardinal Health 414, LLC - Form 483, 2013-11-08
May, 2013 FDA 483 Jubilant HollisterStier LLC - Form 483, 2013-05-10
March, 2013 EIR SEAGEN INC. - EIR, 2013-03-20
July, 2011 FDA 483 International Isotopes Inc - Form 483, 2011-07-22
November, 2014 FDA 483 Galena Biopharma, Inc. - Form 483, 2014-11-21
April, 2003 EIR Madison County Medical Equipment Incorporated - EIR, 2003-04-10
November, 2011 FDA 483 Melaleuca Inc - Form 483, 2011-11-02

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