FDA Investigator Michele Perry Williams

Michele Perry Williams has conducted inspections on 274 sites in 18 countries as of 25 Oct 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
274
Last Inspection Date:
25 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Netherlands, United States of America, Slovenia, Poland, United Kingdom of Great Britain and Northern Ireland, Brazil, Germany, France, Spain, Taiwan, India, Japan, Romania, Italy, Ireland, China, Argentina, Belgium
FDA Investigators that have inspected at least one site in common with Michele Perry Williams:
Adree N Anderson, Adrienne Morgan, Akbar J Zaidi, Alan E Mehl, Alan L Truong, Alan M Barker, Alan M Roberts, Alanna L Mussawwir Bias, Alex M Viehmann, Alicia M Mozzachio, Almaris N Alonso, Alysia C Alger, Amir A Abdalla, Amy E Devine, Ana Paulap Sandee, Anastasia M Shields, Anders W Evenson, Andrew A Hoopes, Andrew J Barrowcliff, Andrew K Schaal, Angela E Glenn, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Anthony A Charity, Anthony J Ladner, Anthony R Bucks, April L Young, Arsen Karapetyan, Ashlee M Ward, Ashley A Mutawakkil, Audrey N Vigil, Avery J Dennis, Azza Talaat, Bapu R Gaddam, Barbara I Rogolsky, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara M Frazier, Bei Y He, Bingchen Du, PhD, Binh T Nguyen, Blondell W Johnson, Bo Chi, PhD, Bonita S Chester, Brenda C Hamilton, Brent M Dehaan, Brent T Hall, Brentley S Collins, Brett R Havranek, Brian A Roelofs, Brian D Nicholson, Bridgette M Mattern, Brittany D Terhar, Bruce E Taylor, Bruce H Mccullough, Bryan S Roddy, Burnell M Henry, Candace S Tucker, Carl A Huffman, III, Carl J Montgomery, Carla A Norris, Carmen Y Fisher, Carolina D Vasquez, Catherine V Quinlan, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, Ceisha C Ukatu, Chad W Rice, Chaoying C Ma, Charisse K Green, Charles I Ann, Charles O'brein, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Cheryl A Clausen, Cheryl A Grandinetti, Chih Jung Hsu, PhD, Chilton L Ng, Chris A Sack, Christian D Lynch (CDL), Christina Capacci Daniel, PhD, Christine A Harman, PhD, Christopher D Leach, Christopher R Czajka, Christopher S Keating, Christopher T Middendorf, Christopher T Peters, Chunsheng Cai, PhD, Claire M Minden, Cody D Rickman, Cody J Alley, Colleen E Burke, Conner N Mann, Courtney N Long, Courtney R Ingalsbe, Courtney R Tiegs, Cristina Ausin Moreno, PhD, Cynthia C Smith, PhD, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia L Evitt, Cynthia M Goudeau, Dale A Nyberg, Damaris Y Hernandez, Dana D Carter, SR DDS, Danial S Hutchison, Daniel J Brown, Daniel R Hurt, Darrah, Darren S Brown, Darren S Morgan, David A Foran, David A Place, David E Lowe, David F Graham, David J Eide, David J Gasparovich, David J Gomes, David L Miser, David M Beltran, David Perkins, Dawn C Olenjack, Deborah J Parris, Debra I Love, Debra Lboyd Seale, Deidre R Edwards, Dell S Moller, Demitria J Xiradakis, Denise M Digiulio, Dennis Cantellops Paite, Derrionna M Epps, Devaughn Edwards, Dewayne E Whitlock, Deyaa Shaheen, Diana K Krepel, Diane L Raccasi, Dilip Devineni, PhD, Dina K West, Dipesh K Shah, Doan T Nguyen, PharmD, Donald L Myers, Douglas A Campbell, Douglas C Kovacs, Douglas M Monroe, Dov H Pluznik, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Jason R Caballero, Dr. Robert C Horan, MD, Dr. Zhou Chen (nmi), MD PhD, Dustin K Hampton, Dwight D Ferguson, Eboni S Funderburk, Edward E Lockwood (EEL), Edwin Jao, Eileen A Liu, Eliezar Ramos, Elizabeth L Philpy, Elmina E Akwo, Elmina E Mboh, Emest F Bizjak, Emilie E Kahn, Emilio O Escobar, Emily J Orban, Emmanuel Jramos Maldonado, Eric C Fox, Eric C Nielsen, Eric M Mueller, PharmD, Eric M Padgett, Erickson, Erika V Butler, Esther C Broner, PhD, Evelyne L Weaver, Farhana Khan, Felix Maldonado, Frank Wackes, Freddy Ortiz Colon, Frederick F Razzaghi, Gene D Arcy, Geneve M Maxwell, Geneve M Parks, Geoffrey K Wong, George J Flynn, Georgia A Layloff, Gloria J Champagne, Gregory W Smith, Gretchen Lf Trendel, Guerlain Ulysse, Gwyn G Dickinson, Hala L Selby, Hamet M Toure, PharmD MPH, Heath W Cartwright, Hector A Carrero, Helen B Ricalde, Helen Y Saccone, Holly Brevig, Hongjian Ding, Huy T Mai, Hyung Yul Lee, Ian L Mcwilliams, Ingrid Y Johnson, Ivis L Negron, J Michael Cannon, PhD, Jacob G Lutz, Jacqueline Mdiaz Albertini, James A Lane, James C Maclaughlin, James D Planchon, James I Giefer, James K Ireland, James K Rice, James P Mcreavey, Janet B Abt, Janet L Bowen, Janete A Eaker, Janete A Oliveira, Janna C Hutchinson, Jason H Wieners, Javier O Vega, Jazmine N Still, Jeanne J Thai, Jeffery A Hangartner, Jeffery L Sumter, Jeffrey A Sommers, Jeffrey B Moody, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer C Adams, Jennifer Cahill, Jennifer L Huntington, Jennifer Lalama, Jesse A Vazquez, Jessica E Hensley, Jessica L Peterson, Jessica L Pressley, Jill J Tillman, Jimmie L Weigand, Joan M Nandrea, Joanne Heim, Joey V Quitania, Jogy George, John A Iwen, John A Marchin, John C Mcmichael, John L Stevens, John T Vonderbrink, Jon P Antoniou, Jonah S Ufferfilge, Jonathan G Gayechuway, Jonathan R Campos, Joohi Castelvetere, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Joseph A Piechocki, Joseph R Lambert, Joseph R Strelnik, Joshua M Adams, Joshua P Wireman, Joslyn K Brunelle, PhD, Juandria V Williams, Juanita P Versace, Judith Hillegas, Julianne C Mccullough, Julie D Bringger, Julie N Vosilus, Julie V Bailey, June P Page, Justin A Boyd, Kalavati Suvarna, PhD, Kara L Cooper, Kara L Roden, Karen C Daugherty, Karen L Kosar, Karen M Cruz Arenas, Karen M Montgomery (KMM), Karen Takahashi, Karthik B Iyer, Katherine E Jacobitz, Katherine M Taylor, Katherine Szestypalow, Kathleen B Swat, Kathleen M Bradley, Kathryn A Bushur, Kellia N Hicks, Kelly A Lynch, Kelly C Ely, Kelly D Sheppard, Kelly K Nachtigal, Ken L Bowers, Kendra A Biddick, Kenneth D Bland, Kenneth H Williams, Kent C Faul, Kevin A Beavers, Kevin A Gonzalez, Kevin Brown, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Krishna Ghosh, PhD, Kristi B Panzer, Kristi M Hampton Thurston, Kshitij A Patkar, Larry K Austin, Laura S Huffman, Lauren N Howard, Laurie A Haxel, Laurie B Frazier, Laurie Graham, Laurimer Kuilan Torres, LCDR Audra J Lenhart, LCDR Ismael Olvera, IV, LCDR Matthew J Morrison, LCDR Sean Byrd, Lequita M Mayhew, Leslie A Paul, Lewis K Antwi, Liming Zhang, Linda F Murphy, Linda R Kuchenthal, Lindsey M Schwierjohann, Linhart, Lionell L Thomas, Lisa D Ellis, Lisa L Flores, Lisa L Gilliam, Lisa M Bellows, Loan Chin, Logan T Williams, Lori A Gioia, Lucas B Leake, Luella J Rossi, Luis A Dasta, Lyndsey G Smith, Mai X Huynh, Marcellinus D Dordunoo, Marcus F Yambot, Margaret A Smithers, Maria A Reed, Maria Cruz Fisher, Marie A Fadden, Marion D Wimberly, Jr, Marion Michaelis, Mark E Parmon, Mark G Peterson, Martha Sullivan Myrick, Marvin D Jones, Mary K Concannon, Mary L Schuckmann, Massod Rahimi, PhD, Matthew A Walburger, Matthew B Casale, Matthew H Hunt, Matthew J Gretkierewicz, Matthew J Sienko, Matthew M Schuckmann, Matthew Ondeck, Matthew R Sleeter, Matthew Schuckman, Megan A Haggerty, Megan M Kirk, Megan T Ziegler, Meisha R Sampson, Meisha Waters, Mel Szymanski, Melinda L Rice, Melissa N Simanton, Melva J Palmer, Michael A Charles, Michael A Feingold, Michael C Zubelewicz, Michael D Porter, Michael E Maselli, Michael P Sheehan, Michael R Goga, Michael S Kopf, Michael S Smoker, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Miguel A Martinez Perez, Mihaly S Ligmond, Minerva Rogers, Miranda D Mcdonald, Mizanne E Lewis, Monica Cburgos Garcia, Monica E Murie, Monica M Mcclure, Monique M Brooks, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra V Millarw, Muna Algharibeh, Muralidhara B Gavini, PhD, Myra K Casey, Nadeem I Chaudhry, Nadine Nanko Johnson, Nancy G Schmidt, Neal L Adams, Nicholas A Violand, Nicholas L Paulin, Nicholas P Diorio, Nicholas Z Lu, Nicole C Mayfield, Nicole C Victoria, PhD, Nicole E Knowlton, Nicole J Conklin, Nicole S Williams, Niketa Patel, Noreen Muñiz, Norman K Starks, Omotunde O Osunsanmi, Paige E Shelborne, Paige E Wilson, Pal S Mayasandra, Pamela L Velez Vega, Pamela N Agaba, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia F Hughes, PhD, Patricia L Payne, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paula A Trost, Pei I Chu, Peng Zhou, Peter G Nilles, Philip A Klimkewicz, Philip F Istafanos, DMV, MS, Philip J Boston, Phillip M Pontikos, Phung Thien Nguyen, Prabhu P Raju, Pratik S Upadhyay, DDC, Qin Xu, Rabia Ballica, PhD, Rafael Padilla, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramon A Hernandez, Ramon E Martinez, Randa Melhem, PhD, Randy D Moore, Rashonda N Rucker, Raymond R Roy, PhD, Raymond T Oji, Rebecca E Dombrowski, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard D Coleman, Richard E Needham, Richard H Penta, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Rick L Friedman, Rita K Kabaso, Robert Barbosa, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert J Ham, Robert J Martin, Robert M Barbosa, Robert R Barbosa, Robert R Wilson, Robin K Reel, Rochelle L Cross, Rodney D Combs, Rodney G Raiford, Roger F Zabinski, Rohit B Kolhatkar, Ronald G Crawford, Rose Ashley, Ross J Grigsby, Ruben C Ayala, PharmD, Russell K Riley, Saied A Asbagh, Salvatore N Randazzo, Samina S Khan, Samuel K Gibbons, Jr, Samuel T Walker, Sandra A Boyd, Sandra A Hughes, Sangeeta M Khurana, PhD, Sanket N Patel, Santos E Camara, Sarah E Morris, Sarah E Rhoades, Sarah M Napier, Sarah Rhoades, Sargum C Sood, Satheesh Thomas, Scott A Golladay, Scott B Laufenberg, Scott R Nichols, PhD, Shafiq S Ahadi, Shalonda C Clifford, Shanna R Haden, Shannan B Beisser, Sharon K Thoma, PharmD, Sheri L Stephenson, Sherry G Bous, Shirley J Berryman, Shirshendu K Deb, PhD, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sneha S Patel, Soyinka S Eneng, Sri Ramakrishnaiah Yellela, PhD, Srinivas R Chennamaneni, PhD, Stephen D Brown, Steven A Gonzales, Steven C Madzo, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven M Weinman, Steven P Allen, Steven P Donald, Stroman, Susan D Yuscius, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Suzanna E Ford, Tamara J Genetti, Tamara J Umscheid, Tamil Arasu, PhD, Tammy L Smith, Tara L Breckenridge, Tara L Greene, Tara L King, Ted L Anderson, Tenzin Jangchup, Teresa I Navas, Thomas A Peter, Thomas J Arista, Thomas J Cosgrove, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Timothy J Schmidt, Tonnie L Carter, Tonya R Johnson, Torrance J Slayton, Torrey M Ward, Toyin B Oladimeji, Tracey Asinjen Wiersma, Tristian E Strait, Truong Xuan Nguyen (Andy), Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Verlinda A Narcisse, Veronica Fuentes, MS, Veronica L Call, Vickie J Kanion, Victoria A Wagoner, Victoria P Quadrini, Vidya B Pai, Vikas Moolchandani, Vincent Thomas, Vioela J Caze, Vlada Matusovsky, Walsworth, Warren J Lopicka, Wayne D Mcgrath, Wayne E Seifert, Wei Hua Emily Wu, Wendy G Tan, PhD, Weston K Szymanski, William C Corley, William D Tingley, William Hallett, PhD, William V Millar, Xiaohan Cai, PhD, Xiaokuang Lai, PhD, Xiaoshi N Wang, Yanming An, PhD, Yaodong Huang, Yasamin Ameri, Yiyue Zhang (nmi), PhD, Yonggang Wang, PhD, Yongmin Liu, Yuan Chia Kuo, Yuanyuan Li, Yumi J Hiramine, Yvonne E Lozano, Zachary A Bogorad, Zedong Dong, Zhang Zhao, PhD, Zhong Li, PhD, Zi Qiang Gu

Michele Perry Williams's Documents

Publish Date Document Type Title
August, 2019 EIR Patheon Biologics LLC - EIR, 2019-08-02
August, 2019 FDA 483 S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2019-08-22
August, 2013 EIR Cambrex Charles City, Inc. - EIR, 2013-08-02
September, 2002 FDA 483 Sparhawk Laboratories, Inc. - Form 483, 2002-09-10
February, 2019 FDA 483 Response S&B Pharma LLC DBA Alkem Laboratories - Form 483R, 2019-02-25
August, 2019 FDA 483 Patheon Biologics LLC - Form 483, 2019-08-02
March, 2008 FDA 483 Response Nesher Pharmaceuticals (USA) LLC - Form 483R, 2008-04-09
May, 2003 FDA 483 Virbac Corporation - Form 483, 2003-05-09
October, 2002 EIR Chemo Biosynthesis s.r.l. - EIR, 2002-10-17
October, 2016 FDA 483 Huvepharma, Inc. - Form 483, 2016-10-26
December, 2000 EIR Bayer Healthcare Animal Health Inc - EIR, 2000-12-07
March, 2018 FDA 483 Apollo Care, LLC - Form 483, 2018-03-13
December, 2001 EIR Sanofi - Aventis US LLC - EIR, 2001-12-27
May, 2002 FDA 483 Vitalab Company, Inc - Form 483, 2002-05-28
March, 2015 FDA 483 Meridian Medical Technologies Inc., A Pfizer Company - Form 483, 2015-03-23
August, 2019 FDA 483 Lafayette Work Center, Inc. - Form 483, 2019-08-29
January, 2004 FDA 483 Noveal - Form 483, 2004-01-22
June, 2013 EIR Baxalta Belgium Manufacturing SA - EIR, 2013-06-18
January, 2000 EIR Bimeda, Inc. - EIR, 2000-01-25
October, 2019 FDA 483 Catalent Indiana, LLC - Form 483, 2019-10-18
October, 2013 FDA 483 Meridian Medical Technologies Inc., A Pfizer Company - Form 483, 2013-10-09
September, 2023 FDA 483 LLOYD, Inc. of Iowa - Form 483, 2023-09-15
February, 2011 FDA 483 Buckeye International, Inc. - Form 483, 2011-02-04
June, 2023 FDA 483 Pharmacia & Upjohn Company LLC - Form 483, 2023-06-16
March, 2008 EIR PD International, LLC. - EIR, 2008-03-26
March, 2003 FDA 483 Strategic Veterinary Pharmaceuticals, Inc. - Form 483, 2003-03-04
August, 2019 FDA 483 Response Patheon Biologics LLC - Form 483R, 2019-08-15
July, 2001 FDA 483 Navy Brand Manufactring Co. - Form 483, 2001-07-19
February, 2009 FDA 483 Kv Pharmaceutical Inc - Form 483, 2009-02-02
February, 2020 FDA 483 Reliable Biopharmaceutical LLC - Form 483, 2020-02-27
March, 2008 FDA 483 Response KV Pharmaceutical Co - Form 483R, 2013-04-09
March, 2017 FDA 483 Sigma-Aldrich Manufacturing LLC - Form 483, 2017-03-10
October, 2012 FDA 483 BIOLOGISCHE HEILMITTEL HEEL GMBH - Form 483, 2012-10-31
September, 2018 FDA 483 JCB Laboratories LLC - Form 483, 2018-09-14
January, 2004 FDA 483 Response BASF SE - Form 483R, 2004-02-06
February, 2001 EIR TriRx Shawnee LLC - EIR, 2001-02-28
September, 2006 EIR Eurofins EAG Materials Science, LLC - EIR, 2006-09-29
June, 2000 FDA 483 Boehringer Ingelheim Vetmedica Inc. - Form 483, 2000-06-30
October, 2002 FDA 483 ACS Dobfar UK Ltd - Form 483, 2002-10-25
March, 2008 FDA 483 Response Ther-RX Corporation - Form 483R, 2008-04-09
April, 2013 FDA 483 Meridian Medical Technologies Inc., A Pfizer Company - Form 483, 2013-04-29
March, 2013 FDA 483 Foundation Care LLC - Form 483, 2013-03-19
November, 2004 FDA 483 Orgapharm - Form 483, 2004-11-11
August, 2004 FDA 483 Nomax, INC - Form 483, 2004-08-25
January, 2004 FDA 483 Response Noveal - Form 483R, 2004-01-29
March, 2012 FDA 483 Sanofi-Aventis US LLC - Form 483, 2012-03-14
July, 2001 FDA 483 Kerry Co Inc - Form 483, 2001-07-13
April, 2016 FDA 483 Response WASHINGTON UNIVERSITY, THE - Form 483R, 2016-11-17
October, 2019 EIR Catalent Indiana, LLC - EIR, 2019-10-18
June, 2013 FDA 483 Baxalta Belgium Manufacturing SA - Form 483, 2013-06-18
August, 2004 FDA 483 Marcus Research Laboratory, Inc. - Form 483, 2004-08-27
November, 2023 FDA 483 Takeda Pharmaceutical Company Limited - Form 483, 2023-11-06
February, 2014 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2014-02-21
February, 2018 FDA 483 ILMO Products Company - Form 483, 2018-02-01
February, 2000 FDA 483 Response EPM Packaging Inc - Form 483R, 2000-02-22
July, 2016 EIR R. Mason (Chemicals) Limited - EIR, 2016-07-21
May, 2007 FDA 483 Bayer Healthcare Animal Health Inc - Form 483, 2007-05-15
September, 2006 FDA 483 Wexford Labs Inc - Form 483, 2006-09-27
June, 2010 FDA 483 Patheon Biologics LLC - Form 483, 2010-06-23
March, 2008 EIR KV Pharmaceutical Co - EIR, 2008-03-26
March, 2017 EIR Sigma-Aldrich Manufacturing LLC - EIR, 2017-03-10
February, 2001 FDA 483 Sparhawk Laboratories, Inc. - Form 483, 2001-02-06
February, 2001 FDA 483 TriRx Shawnee LLC - Form 483, 2001-02-28
September, 2011 FDA 483 Chemisphere Corporation - Form 483, 2011-09-16
June, 2000 EIR Boehringer Ingelheim Vetmedica Inc. - EIR, 2000-06-30
December, 2014 FDA 483 Virbac Corporation - Form 483, 2014-12-30
May, 2015 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2015-05-07
October, 2017 FDA 483 Hospira, Inc. - Form 483, 2017-10-27
March, 2008 EIR Nesher Pharmaceuticals (USA) LLC - EIR, 2008-03-26
July, 2006 FDA 483 Vitalab Company, Inc - Form 483, 2006-07-24
October, 2002 EIR Acs Dobfar U.K. Ltd - EIR, 2002-10-25
August, 2012 FDA 483 Curium US LLC - Form 483, 2012-08-06
May, 2004 FDA 483 Vitalab Company, Inc - Form 483, 2004-05-13
June, 2003 EIR Strategic Veterinary Pharmaceuticals, Inc. - EIR, 2003-06-27
May, 2015 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2015-05-07
June, 2012 EIR Sigma-Aldrich Manufacturing LLC - EIR, 2012-06-18
October, 2017 EIR Hospira, Inc. - EIR, 2017-10-27
February, 2000 FDA 483 EPM Packaging Inc - Form 483, 2000-02-11
November, 2004 EIR Orgapharm - EIR, 2004-12-14
June, 2000 FDA 483 Response Boehringer Ingelheim Vetmedica Inc. - Form 483R, 2000-11-09
March, 2015 EIR Meridian Medical Technologies, LLC - EIR, 2015-03-23
July, 2018 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2018-07-18
May, 2015 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2015-05-07
November, 2022 EIR ANI Pharmaceuticals, Inc. - EIR, 2022-12-14
November, 2016 FDA 483 ROI Consolidated Service Center - Form 483, 2016-11-29
February, 2007 FDA 483 B & G Labs, Inc - Form 483, 2007-02-01
July, 2009 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2009-07-31
June, 2012 EIR Sigma-Aldrich Manufacturing LLC - EIR, 2012-06-18
June, 2016 FDA 483 Response Hospira, Inc. - Form 483R, 2016-06-29
December, 2000 FDA 483 Bayer Healthcare Animal Health Inc - Form 483, 2000-12-07
July, 2016 FDA 483 R. Mason (Chemicals) Limited - Form 483, 2016-07-21
May, 2003 FDA 483 Med Resources, Inc. - Form 483, 2003-05-23
June, 2016 EIR Hospira, Inc. - EIR, 2016-06-08
July, 2002 FDA 483 Boehringer Ingelheim Vetmedica Inc. - Form 483, 2002-07-19
January, 2005 FDA 483 VVF Kansas Services LLC - Form 483, 2005-01-20
October, 2019 FDA 483 Response Catalent Indiana, LLC - Form 483R, 2019-11-08
July, 2014 FDA 483 UBI Pharma Inc. - Form 483, 2014-07-18
January, 2020 FDA 483 Apertus Pharmaceuticals, LLC - Form 483, 2020-01-22
March, 2015 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2015-03-23
May, 2018 FDA 483 Response Rising Pharma Holdings, Inc. - Form 483R, 2018-06-07
July, 2002 EIR Boehringer Ingelheim Vetmedica Inc. - EIR, 2002-07-19
December, 2017 EIR AbbVie Inc. - EIR, 2017-12-15
April, 2010 EIR Hospira, Inc. - EIR, 2010-04-16
September, 2022 FDA 483 Marcus Research Laboratory, Inc. - Form 483, 2022-09-02
February, 2019 FDA 483 S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2019-02-06
August, 2010 FDA 483 Response Eurofins EAG Materials Science, LLC - Form 483R, 2010-08-26
February, 2001 EIR Sparhawk Laboratories, Inc. - EIR, 2001-02-06
November, 2015 FDA 483 Curium US LLC - Form 483, 2015-11-13
November, 2022 FDA 483 ANI Pharmaceuticals, Inc. - Form 483, 2022-11-18
June, 2014 FDA 483 PD International, LLC. - Form 483, 2014-06-02
November, 2006 FDA 483 Integris Bioservices LLC - Form 483, 2006-11-17
October, 2002 FDA 483 Response Chemo Biosynthesis s.r.l. - Form 483R, 2002-11-22
December, 2017 FDA 483 AbbVie Inc. - Form 483, 2017-12-15
September, 2000 EIR Sanofi - Aventis US LLC - EIR, 2000-09-26
January, 2000 FDA 483 Response Bimeda, Inc. - Form 483R, 2000-08-07
January, 2003 EIR TriRx Shawnee LLC - EIR, 2003-01-29
March, 2019 FDA 483 Nantong Chanyoo Pharmatech Co., Ltd - Form 483, 2019-03-22
July, 2014 FDA 483 Huvepharma, Inc. - Form 483, 2014-07-02
March, 2008 EIR Ther-RX Corporation - EIR, 2008-03-26
January, 2015 EIR Infomed Fluids Srl - EIR, 2015-01-20
June, 2018 FDA 483 MINAKEM DUNKERQUE PRODUCTION - Form 483, 2018-06-22
April, 2016 FDA 483 WASHINGTON UNIVERSITY, THE - Form 483, 2016-04-01
September, 2022 FDA 483 Missouri Analytical Laboratories, Inc. - Form 483, 2022-09-02
June, 2009 FDA 483 Consolidated Chemical, Inc. DBA CARE-TECH Laboratories, Inc. - Form 483, 2009-06-12
February, 2016 EIR Pfizer Inc - EIR, 2016-02-16
March, 2008 EIR Nesher Pharmaceuticals (USA) LLC - EIR, 2008-03-26
March, 2023 FDA 483 Rohto Pharmaceutical Co., Ltd. - Form 483, 2023-03-08
September, 2002 EIR Sparhawk Laboratories, Inc. - EIR, 2002-09-10
October, 2002 FDA 483 Chemo Biosynthesis s.r.l. - Form 483, 2002-10-17
August, 2003 FDA 483 IodiTech, Inc. - Form 483, 2003-08-05
April, 2006 FDA 483 Strategic Veterinary Pharmaceuticals, Inc. - Form 483, 2006-04-03
August, 2001 FDA 483 Performance Products Inc. - Form 483, 2001-08-01
August, 2012 EIR Curium US LLC - EIR, 2012-08-06
February, 2007 FDA 483 Chemisphere Corporation - Form 483, 2007-02-12
August, 2000 EIR TriRx Shawnee LLC - EIR, 2000-08-30
March, 2008 EIR KV Pharmaceutical Co - EIR, 2008-03-26
March, 2013 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2013-03-04
January, 2004 EIR Noveal - EIR, 2004-03-05
April, 2012 FDA 483 Reliable Biopharmaceutical LLC - Form 483, 2012-04-27
March, 2008 EIR Nesher Pharmaceuticals (USA) LLC - EIR, 2008-03-26
March, 2008 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2008-03-26
October, 2002 FDA 483 Response Acs Dobfar U.K. Ltd - Form 483R, 2002-11-27
March, 2015 FDA 483 Consolidated Chemical, Inc. DBA CARE-TECH Laboratories, Inc. - Form 483, 2015-03-24
January, 2004 EIR BASF SE - EIR, 2004-03-05
March, 2017 FDA 483 Buckeye International, Inc. - Form 483, 2017-03-01
April, 2016 EIR WASHINGTON UNIVERSITY, THE - EIR, 2016-04-01
March, 2019 FDA 483 Zhejiang Jingwei Pharmaceutical Co., Ltd. - Form 483, 2019-03-15
January, 2004 FDA 483 BASF Aktiengesellshaft - Form 483, 2004-01-16
December, 2019 FDA 483 Marcus Research Laboratory, Inc. - Form 483, 2019-12-06
December, 2010 FDA 483 Forest Pharmaceuticals Inc - Form 483, 2010-12-21
May, 2023 FDA 483 Helget Gas Products, Inc. - Form 483, 2023-05-25
January, 2020 FDA 483 NorthStar Medical Radioisotopes, LLC - Form 483, 2020-01-16
December, 2002 EIR Sanofi - Aventis US LLC - EIR, 2002-12-06
March, 2013 FDA 483 Response Foundation Care LLC - Form 483R, 2013-04-09
August, 2010 EIR Eurofins EAG Materials Science, LLC - EIR, 2010-08-23
July, 2014 FDA 483 BORA PHARMACEUTICAL LABORATORIES INC. - Form 483, 2014-07-26
May, 2019 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2019-05-31
January, 2000 FDA 483 Bimeda, Inc. - Form 483, 2000-01-25
December, 2011 FDA 483 S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2011-12-16
June, 2014 EIR PD International, LLC. - EIR, 2014-06-02
May, 2003 EIR Virbac Corporation - EIR, 2003-05-09
April, 2002 FDA 483 ALI Pharmaceutical Manufacturing, LLC - Form 483, 2002-04-05
June, 2016 FDA 483 Hospira, Inc. - Form 483, 2016-06-08
September, 2015 FDA 483 Huvepharma, Inc. - Form 483, 2015-09-15
February, 2016 FDA 483 Pfizer Inc - Form 483, 2016-02-16
May, 2011 EIR Meridian Medical Technologies, LLC - EIR, 2011-05-12
October, 2003 EIR GSK Consumer Health, Inc. - EIR, 2003-10-30
June, 2012 FDA 483 Sigma-Aldrich Mfg LLC - Form 483, 2012-06-18
May, 2018 FDA 483 Rising Pharma Holdings, Inc. - Form 483, 2018-05-16
May, 2019 FDA 483 Nesher Pharmaceuticals (USA) LLC - Form 483, 2019-05-31
September, 2019 FDA 483 Eurofins EAG Materials Science, LLC - Form 483, 2019-09-24
July, 2002 FDA 483 Response Boehringer Ingelheim Vetmedica Inc. - Form 483R, 2002-08-30
February, 2000 EIR EPM Packaging Inc - EIR, 2000-02-11
December, 2001 FDA 483 Sanofi - Aventis US LLC - Form 483, 2001-12-27
June, 2012 EIR Sigma-Aldrich Mfg LLC - EIR, 2012-06-18
February, 2023 FDA 483 TOYOBO CO., LTD. - Form 483, 2023-02-25
August, 2010 FDA 483 Eurofins EAG Materials Science, LLC - Form 483, 2010-08-23
May, 2007 EIR Bayer Healthcare Animal Health Inc - EIR, 2007-05-15

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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