FDA Investigator Michele L Obert

Michele L Obert has inspections in 26 countries as of 15 Sep 2023. Michele L Obert has collaborated with a combinined 10841 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
204
Last Inspection Date:
15 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Japan, United States of America, Germany, Italy, France, United Kingdom of Great Britain and Northern Ireland, India, Australia, Denmark, Spain, Switzerland, Slovenia, Belgium, Ireland, New Zealand, Austria, China, Bulgaria, Sweden, South Africa, Singapore, Poland, Iceland, Netherlands, Malta
Co-Investigator(s):
Adam R Cooke, Ademola O Daramola, Adree N Anderson, Alan E Mehl, Alan L Brend, Alan L Truong, Alan M Barker, Alanna Lmussawwir Bias, Albinus M D Sa, Alex M Viehmann, Alicia M Mozzachio, Alysia C Alger, Alysia C Investigator, Amir A Abdalla, Amy E Devine, Ana Paulap Sandee, Anastasia M Shields, Andrew A Hoopes, Angela E Glenn, Anissa M Vargas, Anita R Michael, Anjali Shukla, PhD, Ann L Demarco, Anna Lazar, Anna M Brannen, Anthony A Charity, Anthony Abel, Anthony C Warchut, Anthony R Bucks, April L Young, Aref M El Demerdash, Ariel Cruz Figueroa, Arsen Karapetyan, Arthur S Williams, Jr, Ashar P Parikh, Ashley A Mutawakkil, Audrey N Vigil, Avery J Dennis, Azza Talaat, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara L Rogolsky, Barbara M Frazier, Bei Y He, Bernice F Hirsch, Bijoy Panicker, Bill Tacket, Jr, Blondell W Johnson, Bo Chi, PhD, Bonita S Chester, Brenda C Hamilton, Brent M Dehaan, Brent T Hall, Brett R Havranek, Brian D Nicholson, Brian D Rogers, Bridgette M Mattern, Brittany D Terhar, Bruce H Mccullough, Bryan S Roddy, Burnell M Henry, Byungja E Marciante, Candace S Tucker, Carl A Huffman, III, Carl J Montgomery, Carl Lee, Carla A Norris, Carla J Lundi, Carmen Y Fisher, Carrie A Hughes, Cary Greene, Catherine J Laufmann, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Charisse K Green, Charles D Brown, Charles I Ann, Charles L Larson, Charles L Zhou, Charles M Edwards, Charles R Cote, RIC, Cheryl A Clausen, Chilton L Ng, Chris A Sack, Christine A Harman, PhD, Christine E Kelley, Christopher D Leach, Christopher T Peters, Chryste Best, Chryste D Best, Cody D Rickman, Cody J Alley, Concannon, Concepcion Cruz, Jr, Conner N Mann, Constantin Y Philopoulos, Courtney R Bratina, Craig D Zagata, Cynthia C Smith, PhD, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia L Evitt, Cynthia M Godeau, Cynthia M Goudeau, Dale A Nyberg, Damaris Y Hernandez, Dana D Carter, SR DDS, Dandan Wang, PhD, Danial S Hutchison, Daniel J Roberts, Daniel R Hurt, Darrah, David A Foran, David A Place, David F Graham, David J Eide, David J Gomes, David L Miser, David M Beltran, Dawn C Olenjack, Deborah J Parris, Debra J Bennett, Debra L Pagano, Dell S Moller, Dennis Cantellops Paite, Derrionna M Epps, Devaughn Edwards, Dewayne E Whitlock, Diana K Krepel, Diane L Raccasi, Dien N Nguyen, Dina K West, Dina Kloost, Doan T Nguyen, PharmD, Don H Bark, PhD, Donald L Lech, Donald L Myers, Donna F Campbell, Douglas A Campbell, Douglas M Monroe, Dr. Carmelo Rosa, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dustin K Hampton, Dwight D Ferguson, Edmond J Baratta, Edmund F Mrak, Jr, Edward E Lockwood (EEL), Edwin Melendez, Elizabeth Ll Edwards, Ellen P Madigan, Emest F Bizjak, Emily J Orban, Eric C Fox, Eric C Nielsen, Eric L Dong, BS, Eric M Mueller, PharmD, Eric M Padgett, Erika V Butler, Erin D Mccaffery, Evelyne L Weaver, Farhana Khan, Felix Maldonado, Francis A Guidry, Frank Wackes, Gam S Zamil, Gayle S Lawson, George J Flynn, Georgia A Layloff, Geraldine D Sanders, Gloria J Champagne, Grace E Mcnally, Gregory D Dixon, Gretchen Lf Trendel, Guerda Prephete, Guerda Prophete, Gwyn D Dickinson, Gwyn G Dickinson, Heath W Cartwright, Hector A Carrero, Helen B Ricalde, Helen Y Saccone, Heriberto Negron Rivera, Ingrid Y Johnson, Ismael Olvera, IV, Ivis Lnegron Torres, J Michael Cannon, PhD, Jacqueline Mdiaz Albertine, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Jagon, James A Liubicich, James C Maclaughlin, James D Planchon, James G Flahive, James I Giefer, James K Rice, James L Dunnie, Jr, James P Mcevoy, James P Mcreavey, Jamie L Dion, Janet B Abt, Janet L Bowen, Jason F Chancey, Javier O Vega, Jawaid Hamid, Jazmine N Still, Jeannie M Vonderbrink, Jeffery A Hangartner, Jeffrey A Sommers, Jeffrey B Moody, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer Cahill, Jennifer D Hollstrom, Jennifer L Huntington, Jennifer Lalama, Jessica E Hensley, Jessica L Peterson, Jessica L Pressley, Jill J Tillman, Jimmie L Weigand, Jimmie L Wiegand, Jmaes I Giefer, Joan A Loreng, Joan M Nandrea, Joanne E King, Joanne Heim, Joel D Hustedt, Joel D Martinez, Joey V Quitania, John A Iwen, John A Marchin, John C Mcmichael, John Dietrick, John F Cipollo, John P Mistler, John T Vonderbrink, Johnsont, Jonathan G Gayechuway, Jonathan R Campos, Jorge L Guadalupe, Jose A Cruz, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose O Hernandez, Jose R Hernandez, Joseph A Piechocki, Joseph R Lambert, Joseph R Strelnik, Juandria Williams, Juanita P Versace, Judith Hillegas, Julie N Vosilus, Junho Opak, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Kara L Cooper, Kara L Roden, Karen C Daugherty, Karen E D'orazio, Karen L Kosar, Karen M Montgomery (KMM), Karlton T Watson, Karthik B Iyer, Karyn M Campbell, Katherine E Jacobitz, Katherine M Taylor, Kathleen B Swat, Kathleen M Bradley, Kathryn A Bushur, Kathryn E Ogger, Kellia N Hicks, Kelly A Lynch, Kelly K Nachtigal, Kelly R Lewis, Kelvin Cheung, Ken L Bowers, Kenneth D Bland, Kenneth G Klobus, Kenneth H Williams, Kenneth V Miller, Kent C Faul, Kevin A Beavers, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Khoa Nathanv Tran, Kim Lthomas Cruse, Kimberly Lewandowski Walker, Kip J Hanks, Kristen D Evans, Kristi Hampton Thurston, Kristi Mhampton Thurston, Kristy A Zielny, Latorie S Jones, Laura S Huffman, Lauren N Howard, Lauren N Smith, Laurie A Haxel, Laurie B Frazier, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Matthew J Morrison, LCDR Michael H Tollon, Leonard H Lavi, Libia M Lugo, Liming Zhang, Linda F Murphy, Linda K Cline, Linda Kuchanthal, Linda L Ng, Linda M Cheny, Linda R Kuchenthal, Linda Thai, Lindsey M Schwierjohann, Linhart, Linwood R Daughtry, Liqun Zhao, Lisa L Flores, Lisa L Gilliam, Lisa M Bellows, Logan T Williams, Lori A Gioia, LT Tamara J Henderson, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis M Burgos Medero, Madushini Dharmasena, PhD, Mai X Huynh, Mamta Gautam Basak, PhD, Marcus F Yambot, Margaret A Smithers, Marianela Aponte Cruz, Marie F Morin, Marion D Wimberly, Jr, Mariza M Jafary, Mark E Parmon, Mark R Mcclain, Mark S Ross, Martin K Yau, PhD, Marvin D Jones, Mary K Concannon, Mary L Schuckmann, Matthew A Walburger, Matthew B Casale, Matthew D Schnittker, Matthew H Hunt, Matthew M Schuckmann, Matthew Ondeck, Matthew R Sleeter, Matthew Schuckman, Megan A Haggerty, Megan M Kirk, Mei Chiung J Huang, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melinda L Rice, Melissa J Garcia, Merril E Racke, Merril Racke, PhD, Michael A Charles, Michael C Zubelewicz, Michael D Porter, Michael E Maselli, Michael J Kuchta, Michael Levin, Michael P Sheehan, Michael R Goga, Michael S Kopf, Michael S Smoker, Michael Shanks, MS, Michele L Chet, Michele L Forster, PhD, Michele L Glendenning, Michele Perry Williams, Michele R Cromer, Miguel A Martinez, Miguel A Martinez Perez, Mihaly S Ligmond, Milva E Melendez, Minerva Rogers, Minh D Phan, Miranda D Mcdonald, Monica E Murie, Monica M Mcclure, Monique M Brooks, Mra B Kamberem, Mra Davism, Mra Mcculloughj, Mra Munizn, Mra Narulaa, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nadine J Nanko, Nadine Nanko Johnson, Nancy G Schmidt, Nancy L Neiger, Nancy L Rolli, Nancy T Waites, Neal L Adams, Nebil A Oumer, Nicholas A Violand, Nicholas L Paulin, Nicole C Mayfield, Nicole J Conklin, Omotunde O Osunsanmi, Paige E Shelborne, Paige E Wiber, Pamela L Vega, Pamela N Agaba, Paraluman S Leonin, Paranthaman Senthamaraikannan, Parul M Patel, Patricia H Dlugosz, Patricia L Payne, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paul L Bellamy, Paula A Trost, Peng Zhou, Penny H Mccarver, Peter C Chow, Peter E Baker, Phillip M Pontikos, Prabhu P Raju, Pratik S Upadhyay, DDC, Qin Xu, Rachel Collen, Rafael Nevarez Nieves, Rafeeq A Habeeb, Ralph A Erickson, Ralph H Vocque, Ralph Jerndal, Randy D Moore, Randy L Self, Raquel Gonzalez Rivera, Rashonda N Rucker, Raymond T Oji, Raymond Valdivia, Reba A Gates, Rebecca Rodriguez, Regina T Brown, Richard D Coleman, Richard E Needham, Richard H Penta, Richard J Friedman, Richard Jay Tucker, RS, Richard K Vogel, Richard L Friedman, Richard L Rutherford, Richmond K Yip, Rick L Friedman, Rita K Kabaso, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert J Doyle, Robert J Ham, Robert J Martin, Robert J Mobley, Jr, Robert R Wilson, Robin K Hatfield, Robin K Reel, Rochelle K Kimmel, Rochelle L Cross, Rodney D Combs, Rohit B Kolhatkar, Rory K Geyer, Rosanna M Goodrich, Rose M Ashley, Roy R Rinc, Ruben C Ayala, PharmD, Russell J Glapion, Russell K Riley, Ruth Moore, PhD, Saied A Asbagh, Saleem A Akhtar, Samina S Khan, Samuel K Gibbons, Jr, Sandra A Boyd, Sandra A Hughes, Sandra G Washko, Sandra G Wheat, Sangeeta M Khurana, PhD, Sarah E Mcmullen, Sarah E Morris, Sarah E Rhoades, Sarah M Meng, Satheesh Thomas, Scott A Golladay, Scott B Laufenberg, Scott E Norris, Scott T Ballard, Sean P Ryan, Sean R Marcsisin, Seneca D Toms, Shafiq S Ahadi, Shanna R Haden, Shannan B Beisser, Sharon K Thoma, PharmD, Shawn R Gould, Sheri L Stephenson, Sherry G Bous, Shirley J Berryman, Shirley J Burryman, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado, Sixto M Mercado Rios, Sneha S Patel, Sony Mathews, Soyinka S Eneng, Sri Ramakrishnaiah Yellela, Srinivas R Chennamaneni, PhD, Stacy C Foster, Stacy C Hetz, State Agency, Stephanie A Slater, MS, Stephen C Smith, Stephen D Brown, Stephen J Koniers, Steven D Kehoe, Steven P Allen, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan W Ting, Susan Zang, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susie H Lee, Suzanna E Ford, Syed N Ali, Tamara J Umscheid, Tamil Arasu, PhD, Tammy L Smith, Tara G Bizjak, Tara L Breckenridge, Tara L Greene, Tara L King, Ted L Anderson, Tenzin Jangchup, Terri L Dodds, Thaddeus T Sze, Thao T Kwan, Thomas A Peter, Thomas J Arista, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiffani D Wilson, Timothy T Kapsala, Tina M Pawlowski, Tina S Roecklein, Tonya R Johnson, Torrance J Slayton, Torrey M Ward, Toyin B Oladimeji, Tracey L Harris, Travis S Bradley, Tricia S Martinez, Tristian E Strait, Truong Xuan Nguyen (Andy), Ucheabuchi C Chudi Nwankwor, Uduak M Inokon, Unnee Ranjan, Verlinda A Narcisse, Veronica Fuentes, MS, Veronica L Call, Vickie J Kanion, Victoria A Wagoner, Victoria P Quadrini, Vikas Moolchandani, Vinh T Phan, Vioela J Caze, Vlada Matusovsky, Walden H Lee, Walsworth, Walsworth Walsworth, Warren J Lopicka, Wayne D Mcgrath, Wayne E Seifert, William A Warnick, William C Corley, William V Millar, Xiaohan Cai, PhD, Xiaokuang Lai, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yiyue Zhang (nmi), PhD, Yuesheng Ye, Yumi J Hiramine, Yvette I Johnson, Zachary A Bogorad, Zedong Dong, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zi Qiang Gu

Michele L Obert's Documents

Publish Date Document Type Title
February, 2004 FDA 483 Response Bayer Aktiengesellschaft - Form 483R, 2004-04-30
March, 2009 FDA 483 NORTON (WATERFORD) LIMITED - Form 483, 2009-03-13
October, 2003 EIR Xellia Pharmaceuticals ApS - EIR, 2003-12-16
July, 2002 EIR Catalent CTS, LLC - EIR, 2002-07-03
April, 2019 FDA 483 AML Riverside, Llc - Form 483, 2019-04-03
November, 2012 FDA 483 Aptuit (Scientific Operations), LLC - Form 483, 2012-11-14
April, 2016 FDA 483 Response Nova-Tech, Inc. - Form 483R, 2016-04-22
September, 2000 EIR Sol Pharmaceuticals, Ltd. - EIR, 2000-09-21
February, 2004 EIR Bayer Aktiengesellschaft - EIR, 2004-04-02
May, 2002 FDA 483 Amino Chemicals Ltd - Form 483, 2002-05-20
April, 2016 FDA 483 Nova-Tech, Inc. - Form 483, 2016-04-22
August, 2002 FDA 483 Eirchem Pharma Services Limited - Form 483, 2002-08-30
May, 2004 FDA 483 Response Spera Nexus, Inc. - Form 483R, 2004-06-16
April, 2015 FDA 483 Hospira, Inc. - Form 483, 2015-04-03
July, 2008 EIR Eurofins BioPharma Product Testing Columbia, Inc. - EIR, 2008-07-31
July, 2000 FDA 483 Response Shanghai Hualian Pharmaceutical Co., Ltd. - Form 483R, 2000-08-10
October, 2003 FDA 483 Xellia Pharmaceuticals ApS - Form 483, 2003-10-03
August, 2013 FDA 483 CERTIFIED SAFETY MANUFACTURING, INC. - Form 483, 2013-08-29
February, 2002 FDA 483 Ioditech Inc - Form 483, 2002-02-25
June, 2005 FDA 483 IMS SRL - Form 483, 2005-06-01
May, 2002 EIR Schema Farmachemical SRL - EIR, 2002-07-09
April, 2005 FDA 483 Response Nostrum Laboratories, Inc. - Form 483R, 2005-05-10
January, 2019 EIR Legacy Pharmaceutical Packaging, LLC - EIR, 2019-01-25
November, 2014 FDA 483 Response Meridian Medical Technologies, LLC - Form 483R, 2014-12-17
April, 2000 FDA 483 York Pharmaceuticals, Inc. - Form 483, 2000-04-07
September, 2000 FDA 483 SOL PHARMACEUTICALS LIMITED - Form 483, 2000-09-21
January, 2017 EIR Acceleration Laboratory Services Inc. - EIR, 2017-01-12
January, 2019 FDA 483 Response Legacy Pharmaceutical Packaging, LLC - Form 483R, 2019-02-15
March, 2007 FDA 483 Centaur, Inc. - Form 483, 2007-03-19
July, 2000 EIR Shanghai Hualian Pharmaceutical Co., Ltd. - EIR, 2000-08-15
July, 2010 FDA 483 Novartis Pharma Stein AG - Form 483, 2010-07-02
October, 2004 FDA 483 Custom Industrial Analysis Laboratories - Form 483, 2004-10-01
May, 2009 FDA 483 IOI Oleo GmbH - Form 483, 2009-05-07
May, 2010 FDA 483 Sparhawk Laboratories, Inc. - Form 483, 2010-05-28
February, 2002 EIR Ioditech Inc - EIR, 2002-02-25
April, 2016 EIR Nova-Tech, Inc. - EIR, 2016-04-22
September, 2000 FDA 483 Response DIVI'S LABORATORIES LIMITED - Form 483R, 2000-10-10
February, 2004 FDA 483 C.A.T. GmbH & Co. Chromatographie und Analysentechnik KG - Form 483, 2004-02-10
February, 2001 EIR Nisshin Pharma Inc. - EIR, 2001-02-16
December, 2017 EIR ALI Pharmaceutical Manufacturing, LLC - EIR, 2017-12-01
August, 2002 EIR Eirchem Pharma Services Limited - EIR, 2002-10-03
January, 2020 EIR Alcami Carolinas Corporation - EIR, 2020-01-16
January, 2013 FDA 483 Reliable Biopharmaceutical LLC - Form 483, 2013-01-25
May, 2004 FDA 483 Iwaki Seiyaku Co. LTD - Form 483, 2004-05-20
September, 2014 FDA 483 Perry Drugs Inc. - Form 483, 2014-09-09
May, 2002 FDA 483 Response Schema Farmachemical SRL - Form 483R, 2002-07-26
December, 2013 FDA 483 University of Iowa Pharmaceuticals - Form 483, 2013-12-13
November, 2001 EIR Nesher Pharmaceuticals (USA) LLC - EIR, 2001-11-02
March, 2017 FDA 483 Response Meridian Medical Technologies, LLC - Form 483R, 2017-04-14
December, 2017 EIR American Laboratories, LLC - EIR, 2017-12-01
November, 2013 EIR TriRx Shawnee LLC - EIR, 2013-11-01
May, 2000 EIR Sanofi - Aventis US LLC - EIR, 2000-05-31
March, 2014 EIR Heraeus Deutschland GmbH &Co. KG - EIR, 2014-03-07
September, 2018 FDA 483 Dong Yuan Technology Co., Ltd. - Form 483, 2018-09-28
December, 2017 FDA 483 ALI Pharmaceutical Manufacturing, LLC - Form 483, 2017-12-01
July, 2002 EIR Boehringer Ingelheim Vetmedica Inc. - EIR, 2002-07-19
April, 2002 EIR Qualis Group LLC - EIR, 2002-04-09
January, 2019 FDA 483 Legacy Pharmaceutical Packaging, LLC - Form 483, 2019-01-25
January, 2015 EIR Alcami Carolinas Corporation - EIR, 2015-01-14
October, 2003 FDA 483 Response Xellia Pharmaceuticals ApS - Form 483R, 2003-10-23
July, 2002 FDA 483 Boehringer Ingelheim Vetmedica Inc. - Form 483, 2002-07-19
December, 2017 FDA 483 American Laboratories, LLC - Form 483, 2017-12-01
July, 2017 FDA 483 Triad Isotopes Inc. - Form 483, 2017-07-03
July, 2013 FDA 483 Biovet-AD - Form 483, 2013-07-26
July, 2015 FDA 483 TriRx Shawnee LLC - Form 483, 2015-07-30
March, 2012 FDA 483 DSP - Form 483, 2012-03-22
February, 2015 EIR S&B Pharma LLC DBA Alkem Laboratories - EIR, 2015-02-26
February, 2004 FDA 483 Response Bayer AG - Form 483R, 2004-05-05
May, 2002 FDA 483 Response Amino Chemicals Ltd - Form 483R, 2002-07-19
November, 2001 FDA 483 KV Pharmaceutical Co - Form 483, 2001-11-02
July, 2002 FDA 483 Response Catalent CTS, LLC - Form 483R, 2002-07-10
January, 2015 FDA 483 Alcami Carolinas Corporation - Form 483, 2015-01-14
February, 2001 EIR Takeda Giken Service, Ltd. - EIR, 2001-02-05
January, 2012 FDA 483 Hospira, Inc. - Form 483, 2012-01-04
December, 2002 FDA 483 Fine Organics Limited - Form 483, 2002-12-10
June, 2005 EIR IMS SRL - EIR, 2005-06-01
February, 2015 FDA 483 Response S&B Pharma LLC DBA Alkem Laboratories - Form 483R, 2015-03-17
April, 2015 EIR Hospira, Inc. - EIR, 2015-04-03
March, 2008 FDA 483 Nostrum Laboratories, Inc. - Form 483, 2008-03-11
February, 2015 FDA 483 LLOYD, Inc. of Iowa - Form 483, 2015-02-20
May, 2005 EIR F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. - EIR, 2005-05-26
September, 2000 FDA 483 DIVI'S LABORATORIES LIMITED - Form 483, 2000-09-15
April, 2000 EIR York Pharmaceuticals Inc - EIR, 2000-04-07
May, 2013 FDA 483 TriRx Shawnee LLC - Form 483, 2013-05-21
February, 2001 FDA 483 Nisshin Pharma Inc. - Form 483, 2001-02-16
February, 2004 EIR Bayer AG - EIR, 2004-04-07
August, 2002 FDA 483 Response Eirchem Pharma Services Limited - Form 483R, 2002-09-12
July, 2013 EIR Biovet-AD - EIR, 2013-07-26
April, 2006 FDA 483 Strategic Veterinary Pharmaceuticals, Inc. - Form 483, 2006-04-03
February, 2004 FDA 483 Response C.A.T. GmbH & Co. Chromatographie und Analysentechnik KG - Form 483R, 2004-05-10
February, 2002 FDA 483 Response Ioditech Inc - Form 483R, 2002-04-12
May, 2002 EIR Amino Chemicals Ltd - EIR, 2002-09-04
February, 2001 FDA 483 Response Takeda Pharmaceutical Company Limited - Form 483R, 2001-02-28
March, 2000 EIR Sanofi - Aventis US LLC - EIR, 2000-03-08
May, 2013 EIR TriRx Shawnee LLC - EIR, 2013-05-21
April, 2002 EIR Microchem SRL - EIR, 2002-04-30
April, 2005 FDA 483 Nostrum Laboratories, Inc. - Form 483, 2005-04-08
July, 2008 EIR Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc. - EIR, 2008-07-31
June, 2014 EIR SpecGx LLC - EIR, 2014-06-12
April, 2013 FDA 483 VVF Kansas Services LLC - Form 483, 2013-04-11
May, 2004 EIR Spera Nexus, Inc. - EIR, 2004-06-25
March, 2008 EIR Nostrum Laboratories, Inc. - EIR, 2008-03-11
March, 2018 EIR Surmasis Pharmaceutical, LLC - EIR, 2018-03-01
January, 2015 FDA 483 Response Alcami Carolinas Corporation - Form 483R, 2015-01-22
November, 2014 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2014-11-25
March, 2004 FDA 483 Ioditech Inc - Form 483, 2004-03-11
April, 2010 EIR Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc. - EIR, 2010-04-23
May, 2000 FDA 483 Sanofi - Aventis US LLC - Form 483, 2000-05-31
February, 2006 FDA 483 LLOYD, Inc. of Iowa - Form 483, 2006-02-17
February, 2015 FDA 483 S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2015-02-26
July, 2002 FDA 483 Response Boehringer Ingelheim Vetmedica Inc. - Form 483R, 2002-08-30
April, 2002 FDA 483 Qualis Group LLC - Form 483, 2002-04-09
June, 2002 FDA 483 Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc. - Form 483, 2002-06-19
March, 2008 FDA 483 Response Nostrum Laboratories, Inc. - Form 483R, 2008-04-08
November, 2001 FDA 483 Kv Pharmaceutical Inc - Form 483, 2001-11-02
May, 2002 FDA 483 Schema Farmachemical SRL - Form 483, 2002-05-07
April, 2010 EIR Eurofins BioPharma Product Testing Columbia, Inc. - EIR, 2010-04-23
May, 2000 EIR Catalent CTS, LLC - EIR, 2000-05-30
July, 2012 EIR Eurofins BioPharma Product Testing Columbia, Inc. - EIR, 2012-07-18
April, 2002 FDA 483 Response Microchem SRL - Form 483R, 2002-04-30
March, 2017 FDA 483 Meridian Medical Technologies, LLC - Form 483, 2017-03-24
July, 2002 FDA 483 Catalent CTS, LLC - Form 483, 2002-07-03
June, 2005 FDA 483 Response IMS SRL - Form 483R, 2005-06-27
March, 2018 FDA 483 Response Surmasis Pharmaceutical, LLC - Form 483R, 2018-03-22
September, 2018 FDA 483 Jiangxi LongLife Bio-Pharmaceutical Co., Ltd. - Form 483, 2018-09-14
October, 2004 EIR Custom Industrial Analysis Laboratories - EIR, 2004-10-01
February, 2001 EIR Takeda Pharmaceutical Company Limited - EIR, 2001-02-09
November, 2013 FDA 483 TriRx Shawnee LLC - Form 483, 2013-11-01
January, 2012 FDA 483 Response Hospira, Inc. - Form 483R, 2012-01-25
January, 2012 EIR Hospira, Inc. - EIR, 2012-01-04
December, 2017 FDA 483 Response ALI Pharmaceutical Manufacturing, LLC - Form 483R, 2017-12-22
January, 2013 EIR Reliable Biopharmaceutical LLC - EIR, 2013-01-25
September, 2000 EIR DIVI'S LABORATORIES LIMITED - EIR, 2000-09-15
May, 2002 EIR Wyeth Lederle SRL - EIR, 2002-05-13
November, 2017 FDA 483 Essential Isotopes, LLC - Form 483, 2017-11-17
February, 2004 EIR C.A.T. GmbH & Co. Chromatographie und Analysentechnik KG - EIR, 2004-03-29
March, 2018 FDA 483 Surmasis Pharmaceutical, LLC - Form 483, 2018-03-01
July, 2010 FDA 483 Novartis Pharma Schweizerhalle AG - Form 483, 2010-07-09
April, 2001 FDA 483 Custom Industrial Analysis Laboratories - Form 483, 2001-04-24
February, 2001 FDA 483 Takeda Chemcial Industries Ltd. - Form 483, 2001-02-09

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