FDA Investigator Robert D Tollefsen

Robert D Tollefsen has conducted inspections on 116 sites in 18 countries as of 04 Dec 2017. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
116
Last Inspection Date:
04 Dec 2017
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Jordan, United States of America, Sweden, India, Germany, Ireland, Australia, Belgium, China, United Kingdom of Great Britain and Northern Ireland, Japan, Spain, Oman, Canada, Israel, France, Switzerland, Singapore
FDA Investigators that have inspected at least one site in common with Robert D Tollefsen:
Aaron P Wozniak, Adam R Cooke, Ademola O Daramola, Aditi S Thakur, Alan P Kurtzberg, Alberto A Viciedo, Alexander M Kay, Alice S Tsao, Alicia M Mozzachio, Alla Kachko, PhD, Amalia C Himaya, Amanda L Fyles, Amanda S Zorn, Amir Alavi, Amy C Jordan, Amy L Singer, Amy M Cramer, Amy N Chen, Ana Delp Cintron, Ana P Barido, Anastasia I Offordile, Anastasia M Shields, Andrace L Deyampert, Andrea A Branche, Andrea D Swingle, Andrea George, PhD, Andrew K Haack, PhD, Angel K Sandhu, Angela E Glenn, Anh M Lac, Anissa M Cheung, Anissa M Vargas, Anita Narula, PhD, Anita R Michael, Ankur C Patel, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Anthony F Lorenzo, April P Shaw, Arie C Menachem, Arsen Karapetyan, Ashar P Parikh, Ashleigh P Barkans, Astrida B Mattson, Atul J Agrawal, Audrey Thereset Uy, Azza Talaat, Barbara J Rincon, Barbara J Wilcox, PhD, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara M Frazier, Barry Cherney, PhD, Bei Y He, Benjamin J Smith, Bichsa T Tran, Bill Tacket, Jr, Binh T Nguyen, Bo Chi, PhD, Bradley Dworak, PhD, Brenda L Reihing, Brenda W Uratani, PhD, Brentley S Collins, Brian D Nicholson, Brian S Keefer, Brien C Fox, Brittny C Cargo, Bruce H Mccullough, Bryan Baker, Bryce A May, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Carl A Anderson, Carl Lee, Carla J Lundi, Carla Lankford, MD, PhD, Carole L Jones, Carolyn A Renshaw, Carrie A Hughes, Carrie Ann Plucinski, Caryn M Everly, Caryn M Mcnab, Catherine J Laufmann, Cathleen A Carr Sharpe, CDR Cecily Jones, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Rochelle B Young, RPh, MSA, CDR Thomas R Berry, PPh, Celeta S Coves, Celia L Hutchinstein, Chad R Burger, Chao Ming Tsai, Charanjeet Jassal, Charisse K Green, Charles D Brown, Charles I Ann, Charles L Zhou, Charles R Cote, RIC, Cheron M Portee, Chiaochun J Wang, Chris A Sack, Christian D Lynch (CDL), Christina C Santos, Christina J Sauder, PhD, Christina V Santos, Christine A Harman, PhD, Christine M Cerenzio, Christine M Humphrey, Christopher D Leach, Christopher D Rush, Christopher J Adams, Christopher R Czajka, Christopher T Middendorf, Clinton J Lott, Concepcion Cruz, Jr, Connie P Rezendes, Constantin Y Philopoulos, Corrine M Carter, Craig A Garmendia, Craig D Zagata, Creighton T Tuzon, Crystal A Harlan, Crystal Monroy, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia L Kelley, Dandan Wang, PhD, Daniel J Brown, Daniel J Lahar, Daniel J Roberts, Daniel W Cline, Darla J Christopher, Darren S Brown, Daryl A Dewoskin, Dave Hafner, David A Paterson, David Frucht, MD, David G Eng, David J Gomes, David J Hafner, David K Glasgow, David M Beltran, David Perkins, Davinna Ligons, PhD, Dawn E Barkans, Dawn M Mccabe, Debara R Reese, Debara Reese, Deborah A Greco, Deborah Hammond, Deborah S Hammond, Debra I Love, Debra J Bennett, Debra L Pagano, Demario L Walls, Demitria J Xiradakis, Denise L Burosh, Denise M Digiulio, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Dennis G Kawabata, Dennis M Farley, Derek S Smith, PhD, Destry M Sillivan, Devaughn Edwards, Devon M Shoop, Deyaa Shaheen, Dhaval H Patel, Diana M Rand, Diane Cvan Leeuwen, Diane L Raccasi, Dianna D Wardlow Dotter, Dien N Nguyen, Dina A Tallman, Dina K West, Dipesh K Shah, Dmitriy V Volokhov, PhD, Doan T Nguyen, PharmD, Dolores E Price, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald L Lech, Donna Ltartaglino Besone, Doreen P Gubbay, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Jason R Caballero, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Willie F Vann, PhD, Dr. Zhihao Qiu (Peter), PhD, Dustin R Abaonza, Dyvette Arline, Edmund F Mrak, Jr, Edward D Harris, Edward Deberry, Edward E Lockwood (EEL), Edwin Melendez, Eileen A Liu, Eileen J Bannerman, Elizabeth B Griffin, Elizabeth S Howell, Ellen Huang, Emest F Bizjak, Emily J Orban, Emily Shacter, Emmanuel Jramos Maldonado, Ephrem Hunde, PhD, Eric C Fox, Eric L Dong, BS, Eric M Mueller, PharmD, Eric M Padgett, Eric Rothschild, Erika V Butler, Erin D Mccaffery, Erin L Mcfiren, Esther C Broner, PhD, Fabian Nchaparro Rodriguez, Farhana Khan, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Gabriel R Mclemore, Gajendiran Mahadevan, PhD, Gam S Zamil, Gene D Arcy, Gene R Gunn, George J Flynn, George Lunn, PhD, George Pyramides, Gerald B Seaborn, Jr, Gerald Feldman, Gerald M Feldman, PhD, Gerald N Mcgirl, DDS, Gerard Pde Leon, Gianine E Tompkins, Ginger M Sykes, Gloria J Baca, MS, Grace E Mcnally, Graham N Giesen, Guerlain Ulysse, Hai Lient Phung, Hala L Selby, Haley H Seymour, Hamet M Toure, PharmD MPH, Haroon Vohra (NMI), Haruhiko Murata, Hasan A Irier, PhD, Heika R Bounds, Heika R Tait, Helen B Ricalde, Helen Verdel, Henry K Lau, Huiquan Wu, Hung H Do, MS, Ibad U Khan, Iris C Macinnes, Ivis L Negron, J David Doleski, J Elkins, Jacek Cieslak, PhD, Jacob G Lutz, Jacqueline Mdiaz Albertini, James A Liubicich, James D Hildreth, James D Planchon, James I Giefer, James L Dunnie, Jr, James M Kewley, James M Mason, James P Stumpff, James R Evans, James R Fleckenstein, James S Stuart, BS, James W Plucinski, Jane M Kreis, Jason F Chancey, Jawaid Hamid, Jean Blackston Hill, Jean Lhu Primmer, Jeanne Fringer, PhD, Jee Chung, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey M Watson, Jeffrey P Raimondi, Jeffrey R Wooley, Jeffrey W Shrifter, DPM, Jen Sui, Jennifer A Kemp, Jennifer D Hollstrom, Jennifer Gogley, Jennifer L Bridgewater, Jennifer L Huntington, Jennifer Lalama, Jennifer M Gogley, Jennifer M Menendez, Jennifer Macmillan, Jessica L Pressley, Jessica L Walters Moell, Jessica M Monteiro, Jianming Li, Joan A Loreng, Joan Adamo, Joan T Briones, Joanne E King, Joanne Hosting, Joanne M Hajoway, Jodi M Gatica, Joel D Hustedt, Joel D Martinez, Joel Welch, PhD, Joey V Quitania, Jogy George, Johann M Fitch, John A Gonzalez, John Burr, John D White, John F Cipollo, John R Myung, Jolanna A Norton, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose Martinez, Jr, Jose R Hernandez, Jose R Lopez, Joseph A Piechocki, Joseph D Gong, Joseph E Duran, Joseph George, Joseph Kutze, PhD, Joseph P Iser, MD, Joseph R Strelnik, Joshua J Silvestri, Joshua S Hunt, Joy Rkozlowski Klena, Jude C Dikes, Julia Ventura, Julian C Hanson, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Ka L Wong, Kaarin M Slotte, Kalavati Suvarna, PhD, Karen A Briggs, Karen C Daugherty, Karen E D'orazio, Karen M Montgomery (KMM), Karen Takahashi, Kari M Johansen, Karlton T Watson, Karyn M Campbell, Katherine E Jacobitz, Katherine Szestypalow, Kathleen B Mihalik, Kathleen B Swat, Kathleen D Culver, Kathleen R Jones, PhD, Kathryn A Krentz, Kathryn Carbone, MD, Kathryn E King, Keegan B Mixon, Keith O Webber, PhD, Keith Webber, PhD, Kelli F Dobilas, Kelli Regente, Kellia N Hicks, Kelly D Sheppard, Kelly N Kerr, Kelvin Cheung, Kelvin X Sanders, Kendra A Biddick, Kenneth M Gordon, Kenneth O Gee, PhD, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Kip J Hanks, Kirsten L Vadheim, PhD, Ko U Min, Kouros Kangarli, Krishna Ghosh, PhD, Kristen D Evans, Kristin M Abaonza, Kristy A Zielny, L'oreal F Walker, Lakisha M Williams, Lance Mde Souza, MBA, Lance Sindo, CIH, CQA, RS, Lane V Christensen, PhD, Larry K Austin, Larry K Hampton, Latorie S Jones, Laura Fontan, MS, Laurel A Beer, Lauren Iacono Connors, PhD, Laurie B Frazier, Laurie Graham, Laurie P Norwood, Lawrence Y Lee, PhD, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Jennifer H Rhyu, LCDR Margaret Edi Gennaro, LCDR Matthew J Morrison, LCDR Michael H Tollon, Lei Zhang, PhD, Leigh Anne Myers, Leiyun Boone, PhD, Leonard H Lavi, Lequita M Mayhew, Lesley K Satterwhite, Leslie D Wagner, Li Li, Liatte Kreuger, PharmD, Libia M Lugo, Liming Zhang, Linan Ha, PhD, Linda F Murphy, Linda K Weir, Linda R Kuchenthal, Linda S Leja, Linda Thai, Lindsey M Schwierjohann, Linh Tu, Lisa C Lewis, Lisa Hayka, Lisa K Capron, Lisa M Bellows, Lisa M Feola, Lisa M Parsons, Loretta J Jordan, Lori J Silverstein, Lori S Lawless, Lorie S Hannappel, LT Daveta L Bailey, LT John M Mastalski, Lucila B Nwatu, Luella J Rossi, Luis A Carrion, Luis A Dasta, Lynda L Perry, PhD, Mabel M Lee, Madushini Dharmasena, PhD, Mai X Huynh, Maida Henesian (NMI), Marc A Jackson, Jr, Marcellinus D Dordunoo, Marcia B Williams, Marcus F Yambot, Margaret M Annes, Margarita Santiago, Maria Joselopez Barragan, PhD, Maria Pkelly Doggett, MBA, Maria V Price, Marian E Major, PhD, Marie A Fadden, Marie F Morin, Marie K Kinkade, Marijo B Kambere, PhD, Marion Michaelis, Mariza M Jafary, Mark C Saale, Mark E Chan, Mark I Schwartz, Mark R Mcclain, Mark W Babbitt, Marlene G Swider, Marsha W Major, Marshalette O Edwards, Martin K Yau, PhD, Marvin D Jones, Mary Jeanet Mcgarry, Massoud Motamed, Matt D Suedkamp, Matthew B Casale, Maurice M Sheehan, Maxine H Wong, Maxwell Van Tassell, PhD, Maxyne T Lam, Maya M Davis, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melanie G Warzala, Melanie M Walker, Melanie W Pishnery, Melina Lrodriguez Upton, Melissa B Libby, Melissa J Garcia, Melissa T Roy, Mercy Oyugi, Meredith L Sheridan, Michael A Charles, Michael C Rogers, Michael Curbarg, Michael D Garcia, Michael F Skelly, PhD, Michael Gurbarg, Michael J Lackey, Michael J Vardon, Michael P Sheehan, Michael R Goga, Michael R Klapal, Michael S Araneta, Michael Serrano, Michael Shanks, MS, Michael T Cyrus, Michele D Thompson, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle A Marsh, Michelle Rfrazier Jessen, PhD, Michelle Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Mikel T Wright, Milos Dokmanovic, PhD, Min Shanmabel Liu, Mohsen Rajabi Abhari, FDA, Monica J Wilkins, Montgomery Montgomery, Karen M, Mra Mcculloughj, Mra V Millarw, Muna Algharibeh, Muralidhara B Gavini, PhD, Myra K Casey, Nadeem I Chaudhry, Nailing Zhang, Nancy A Bellamy, Nancy A Saxenian Emmons, Nancy E Byerly, Nancy F Scheraga, Nancy G Schmidt, Nancy M Espinal, Nasir Ali, PhD, Natalia Pripuzova, PhD, Nataniel Phillips Sylvain, PhD, Navista C Bolton, Nawab A Siddiqui, Nayan J Patel, Neali H Lucas, Nealie C Newberger, Nibin Varghese, MS, Nicholas F Lyons, Nicholas L Hunt, Nicholas L Paulin, Nicholas Obiri, PhD, Nicola M Fenty Stewart, Nicole A Lloyd, Nicole E Knowlton, Nicole K Trudel, Niketa Patel, Norman K Starks, Omotunde O Osunsanmi, Pankaj H Amin, Parul M Patel, Patricia A Cochran, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick B Cummings, Patrick D Stone, MS, Patsy J Domingo, Paul F Rader, Paul J Teitell, Paul L Bellamy, Paul Lihong Yeh, PhD, Paul Rader, Paul W Keller, Paul Z Balcer, Paula A Trost, Penny H Mccarver, Peter C Chow, Peter E Baker, Peter Kessler, PhD, Peter S Diak, Philip J Boston, Phillip M Pontikos, Phung Thien Nguyen, Prabhu P Raju, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Qing Joanna Zhou, PhD, R Edwadebey Deberry, Rafael E Arroyo, Rafael Nevarez Nieves, Rafeeq A Habeeb, Ralph A Erickson, Ramon E Martinez, Randa Melhem, PhD, Randall N Johnson, Randy L Self, Raymond T Oji, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Reyes Candau Chacon, PhD, Richard E Needham, Richard H Penta, Richard Heath Coats, Richard K Vogel, Richard L Friedman, Richard Ledwidge (nmi), PhD, Richard W Thornton, Richmond K Yip, Riley C Myers, PhD, Rita K Kabaso, Robert B Shibuya, MD, Robert C Coleman, Robert Darius, Robert J Ham, Robert Jennings, Robert M Barbosa, Robin Levis, PhD, Rocco C Black, Rochelle K Kimmel, Roger F Zabinski, Rona Leblanc, PhD, Ronald L Koller, Ronda Leblanc, Rose Ashley, Rowena S Nguyen, Roy R Rinc, Rumany C Penn, PharmD, Russell K Riley, Ruth Moore, PhD, S Lori Brown, PhD MPH, Sachinkumar V Patel, Saied A Asbagh, Saleem A Akhtar, Samantha J Bradley, Samuel K Gibbons, Jr, Sandra A Boyd, Sandra A Hughes, Sandra S Saniga, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Santiago Gallardo Johnson, Santos E Camara, Sara H Gabel, Sarah Arden, Sarah B Tanksley, Sarah E Mcmullen, Sarah E Rhoades, Satheesh Thomas, Scott A Nabe, Scott E Norris, Scott N Lim, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Seneca D Toms, Serge L Beaucage, Shafiq S Ahadi, Shari H Shambaugh, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Sheilyn H Huang, Shelby N Turner, Shelley H Beausoleil, Shererk, Sherri J Jackson, Sherri N Rohlf, MD, Shuang Tang, Shuen G Chai, Sidney B Priesmeyer, Simone E Pitts, Sinai I Davis, Sneha S Patel, Sonia R Peterson, Sonya M Edmonds, Sridhar Thumma, Stacey S Degarmo, Stanley Au, Stephanie A Slater, MS, Stephanie D Crockett, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen D Brown, Stephen J Mottola, Stephen L Beekman, Stephen R Souza, Steven A Gonzales, Steven A Rubin, Steven C Madzo, Steven D Kehoe, Steven Eastham, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Stuart W Russell, Sue Lee Chan, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan F Laska, MS, Susan M Corrales, Susan M Jackson, Susan M Turcovski, Susan P Bruederle, Susan T Hadman, Susan W Ting, Suyang Qin, Suzanne N Vallez, Syed N Ali, Taichun Qin, PhD, Tajah L Blackburn, Tamika White, Tammy L Chavis, Tania Y Hall, Ted L Anderson, Temar Q Williams, Teresa I Navas, Terrance L Thomas, Terri L Dodds, Thai D Truong, Thao T Kwan, Thao X Tran, Thea C Grome, Thomas J Arista, Thomas W Gordon, Thuy T Nguyen, LCDR, Timothy C Grome, Timothy T Kapsala, Tina M Pawlowski, Tina S Roecklein, Todd M Stankewicz, Tonia F Bernard, Toyin B Oladimeji, Tracey L Harris, Tracy K Li, Truong Xuan Nguyen (Andy), Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vanessa R Muller, Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Verlinda A Narcisse, Veronica Fuentes, MS, Vibhakar J Shah, PhD, Vioela J Caze, Virgilio F Pacio, CSO, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wayne T Smith, Wei Wang, PhD, William D Tingley, William F Lagud, Jr, William Hallett, PhD, William J Leonard, William V Millar, Xianghong Jing (Emily), PhD, Xiao Wang, Xiaohan Cai, PhD, Xiaojun Yan, Xiaokuang Lai, PhD, Xing Wang, PhD, Xiomara Copeland, Yangmin Ning, Yasamin Ameri, Yetao Jin, PhD, Yi Wang, PhD, Yong Hu, Yumi J Hiramine, Yvesna C Blaise, Yvette I Johnson, Yvonne C Mcknight, Yvonne C Wilkes, Yvonne E Lozano, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zakaria I Ganiyu, Zhongren Wu, Ziyang Su, PhD

Robert D Tollefsen's Documents

Publish Date Document Type Title
June, 2016 FDA 483 Lonza Bend Inc. - Form 483, 2016-06-03
March, 2002 FDA 483 Interquim, S.A. - Form 483, 2002-03-19
December, 2000 FDA 483 Merck, Sharp & Dohme (Australia) Pty. - Form 483, 2000-12-15
December, 2001 EIR Central Glass CO., LTD. - EIR, 2001-12-06
October, 2002 EIR Bio-Technology General, Ltd. - EIR, 2002-10-24
March, 2003 FDA 483 Bridgeport Wholesale Products, Inc - Form 483, 2003-03-11
October, 2002 EIR Taro Pharmaceutical Industries Ltd. - EIR, 2002-10-31
August, 2002 FDA 483 Western Institutional Review Board, Inc. - Form 483, 2002-08-23
March, 2002 FDA 483 AGC Pharma Chemicals Europe, S.L.U . - Form 483, 2002-03-13
January, 2004 FDA 483 Wockhardt Limited - Form 483, 2004-01-30
November, 2005 FDA 483 NorMed - Form 483, 2005-11-04
July, 2000 EIR Pharmacia & Upjohn AB - EIR, 2001-06-13
August, 2003 EIR Integra Chemical Company - EIR, 2003-08-12
March, 2002 EIR Interquim, S.A. - EIR, 2002-03-19
June, 2016 FDA 483 Lonza Bend Inc. - Form 483, 2016-06-03
September, 2013 FDA 483 Genentech, Inc. - Form 483, 2013-09-06
March, 2003 EIR Bridgeport Wholesale Products, Inc - EIR, 2003-03-11
November, 2017 FDA 483 Baxter Healthcare Corporation - Form 483, 2017-11-17
April, 2003 EIR Fine Howard - EIR, 2003-04-04
March, 2003 FDA 483 Response Bridgeport Wholesale Products, Inc - Form 483R, 2003-04-03
November, 2003 FDA 483 Response Magno-Humphries, Inc. - Form 483R, 2004-01-23
August, 2002 FDA 483 Response WCG IRB, Inc - Form 483R, 2002-09-19
December, 2000 FDA 483 Amdel - Form 483, 2000-12-07
March, 2015 FDA 483 S.R. Burzynski Manufacturing Facility - Form 483, 2015-03-19
January, 2004 FDA 483 Response Wockhardt Limited - Form 483R, 2004-03-06
November, 2016 FDA 483 Partner Therapeutics, Inc. - Form 483, 2016-11-18
September, 2002 EIR Pacific University Institutional Review Board - EIR, 2002-09-05
January, 2018 FDA 483 Med-Pharmex, Inc - Form 483, 2018-01-11
July, 2015 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2015-07-17
January, 2011 FDA 483 Reckitt Benckiser, Inc. - Form 483, 2011-01-05
February, 2016 FDA 483 Response Morton Grove Pharmaceuticals, Inc. - Form 483R, 2016-03-07
September, 2015 FDA 483 Lonza Bend Inc. - Form 483, 2015-09-17
June, 2011 FDA 483 Elekta Inc - Form 483, 2011-06-17
August, 2004 FDA 483 Response Amgen, Inc. - Form 483R, 2004-08-27
September, 2002 FDA 483 Pacific University Institutional Review Board - Form 483, 2002-09-05
March, 2002 FDA 483 Novartis Pharma Produktions GmbH - Form 483, 2002-03-08
January, 2005 EIR Allergan Sales, LLC - EIR, 2005-01-28
June, 2016 FDA 483 Lonza Bend Inc. - Form 483, 2016-06-03
November, 2003 FDA 483 Magno-Humphries, Inc. - Form 483, 2003-11-21
December, 2000 FDA 483 Mayne Pharma International Pty Ltd. - Form 483, 2000-12-05
July, 2000 FDA 483 Response Pharmacia & Upjohn AB - Form 483R, 2000-07-20
March, 2002 EIR AGC Pharma Chemicals Europe, S.L.U . - EIR, 2002-04-22
May, 2013 FDA 483 Jubilant HollisterStier LLC - Form 483, 2013-05-10
November, 2001 FDA 483 Eli Lilly and Company - Form 483, 2001-11-14
June, 2000 FDA 483 Pharmacia Corp. - Form 483, 2000-12-07
May, 2003 EIR OFD Biopharma, LLC - EIR, 2003-05-16
March, 2002 FDA 483 Response Novartis Pharma Produktions GmbH - Form 483R, 2002-03-21
December, 2001 FDA 483 Central Glass CO., LTD. - Form 483, 2001-12-06
January, 2004 EIR Wockhardt Limited - EIR, 2004-03-26
October, 2002 FDA 483 Response Taro Pharmaceutical Industries Ltd. - Form 483R, 2002-11-25
April, 2003 FDA 483 Response MDS Pharma Services - Form 483R, 2003-05-08
February, 2010 FDA 483 AMPAC Fine Chemicals LLC - Form 483, 2010-02-19
May, 2003 FDA 483 OFD Biopharma, LLC - Form 483, 2003-05-16
April, 2003 FDA 483 Fine Howard - Form 483, 2003-04-04
March, 2000 EIR C C L Industries - EIR, 2000-03-24
January, 2015 FDA 483 Soft Computer Consultants, Inc. - Form 483, 2015-01-15
March, 2005 FDA 483 Magno-Humphries, Inc. - Form 483, 2005-03-11
September, 2006 FDA 483 Genentech, Inc. - Form 483, 2006-09-29
August, 2003 FDA 483 Integra Chemical Company - Form 483, 2003-08-12
March, 2000 FDA 483 CCL Pharmaceuticals - Form 483, 2000-03-24
October, 2002 FDA 483 Response Bio-Technology General, Ltd. - Form 483R, 2002-11-12
September, 2009 FDA 483 Actavis Laboratories FL, Inc. - Form 483, 2009-09-04
November, 2000 EIR Sato Yakuhin Kogyo Co., Ltd. - EIR, 2000-11-24
September, 2015 FDA 483 Lonza Bend Inc. - Form 483, 2015-09-17
January, 2005 FDA 483 Allergan Sales, LLC - Form 483, 2005-01-28
February, 2016 FDA 483 Morton Grove Pharmaceuticals, Inc. - Form 483, 2016-02-05
April, 2003 EIR MDS Pharma Services - EIR, 2003-04-22
July, 2013 FDA 483 University of Washington PET Radiochemistry Laboratory - Form 483, 2013-07-18
January, 2005 FDA 483 Response Allergan Sales, LLC - Form 483R, 2005-02-18
December, 2001 FDA 483 Response Central Glass CO., LTD. - Form 483R, 2001-12-06
November, 2000 FDA 483 Sato Yakuhin Kogyo Co., Ltd. - Form 483, 2000-11-24
August, 2002 EIR WCG IRB, Inc - EIR, 2002-08-23
February, 2008 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2008-02-12
July, 2000 FDA 483 Pharmacia Corp. - Form 483, 2000-12-07
September, 2006 EIR Genentech, Inc. - EIR, 2006-09-21
December, 2002 FDA 483 University of Washington - Form 483, 2002-12-24
January, 2014 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2014-01-17
July, 2004 FDA 483 Amgen, Incorporated - Form 483, 2004-07-16
December, 2002 EIR Chesnut, Charles III, MD - EIR, 2002-12-24
May, 2003 FDA 483 Response OFD Biopharma, LLC - Form 483R, 2003-06-16
September, 2008 FDA 483 Novo Nordisk Pharmaceutical Industries, LP - Form 483, 2008-09-26
October, 2002 FDA 483 Taro Pharmaceutical Industries Ltd. - Form 483, 2002-10-31
June, 2016 EIR Lonza Bend Inc. - EIR, 2016-06-03
December, 2012 FDA 483 Blood Bank Computer Systems, Inc. - Form 483, 2012-12-10
February, 2014 FDA 483 Seqirus Inc - Form 483, 2014-02-12
June, 2000 EIR Pfizer Health AB - EIR, 2000-06-22
March, 2002 EIR Novartis Pharma Produktions GmbH - EIR, 2002-04-12
November, 2001 FDA 483 Response Eli Lilly and Company - Form 483R, 2001-12-03
June, 2004 FDA 483 Amgen, Inc. - Form 483, 2004-06-17
February, 2013 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2013-02-06
April, 2003 FDA 483 Response Fine Howard - Form 483R, 2003-04-18
September, 2002 FDA 483 Response Pacific University Institutional Review Board - Form 483R, 2002-09-27
June, 2004 EIR Amgen, Inc. - EIR, 2004-06-17
April, 2003 FDA 483 MDS Pharma Services - Form 483, 2003-04-22
October, 2002 FDA 483 Bio-Technology General, Ltd. - Form 483, 2002-10-24

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