FDA Investigator Jose Acruz Gonzalez

Jose Acruz Gonzalez has conducted inspections on 295 sites in 39 countries as of 04 Nov 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
295
Last Inspection Date:
04 Nov 2019
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Germany, China, Korea (Republic of), Austria, Puerto Rico, Japan, Netherlands, Singapore, France, Serbia, Switzerland, India, Turkey, Spain, United Kingdom of Great Britain and Northern Ireland, Italy, Ireland, Australia, South Africa, Sweden, Argentina, Taiwan, Saudi Arabia, Denmark, Canada, Aruba, Finland, Brazil, Mexico, Vietnam, Sudan, Poland, Norway, Hungary, Latvia, Slovakia, Belgium, Costa Rica
FDA Investigators that have inspected at least one site in common with Jose Acruz Gonzalez:
Adalberto Cajigas, Adaliz Santaliz Cruz, Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Agnes M Santori, Akbar J Zaidi, Alan A Rivera, Alan L Truong, Alan P Kurtzberg, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Allison A Aldridge, PhD, Almaris N Alonso, An T Vu, Ana M Rivera, Ana P Barido, Anastasia G Lolas, Anastasia M Shields, Andrea George, PhD, Andrew J Barrowcliff, Andria L Kuhlman, Angela E Glenn, Angelica M Hernandez, Anh M Lac, Anita Narula, PhD, Anita R Michael, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Annemarie Bodnar, Annette Melendez, Anthony A Charity, Anthony C Taube, Anthony C Warchut, Anthony F Lorenzo, Anthony J Grace, April L Young, Ariel Cruz Figueroa, Arlene M Badillo, Arsen Karapetyan, Ashar P Parikh, Ashley J Burns, Ashley L Reiber, Ashley N Queen, PhD, Atul J Agrawal, Azza Talaat, Barbara I Rogolsky, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara M Frazier, Benton M Ketron, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brandy N Lepage, Brenda Rivera, Bruce H Mccullough, Bryan A Galvez, Burnell M Henry, Calvin B Koerner, Camerson E Moore, Candace Y Gomez Broughton, Carl A Anderson, Carl A Huffman, III, Carla J Lundi, Carlos A Medina, Carol L Rehkopf, Carolyn A Renshaw, Carrie A Hughes, Caryn M Mcnab, Cassandra L Abellard, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Rochelle B Young, RPh, MSA, CDR Thomas R Berry, PPh, Charanjeet Jassal, Charisse K Green, Charles D Brown, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheryl A Clausen, Chiang Syin, PhD, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christine W Twohy, Christopher D Leach, Christopher Downey, PhD, Christopher R Czajka, Christopher S Keating, Christopher T Middendorf, Christopher T Peters, Claire M Minden, Colleen Thomas, PhD, Concepcion Cruz, Jr, Connie R Kiessling, Constance Y Fears, Constantin Y Philopoulos, Craig A Garmendia, Cynthia Jim, CSO, Cynthia M Goudeau, Daniel L Zheng, Darren S Brown, David A Oluwo, David J Gomes, David K Lau, David M Beltran, David Perkins, Dawn M Braswell, Dayna I Martinez, Dell S Moller, Demitria J Xiradakis, Denise Connelly, Denise M Digiulio, Dennis Cantellops Paite, Devaughn Edwards, Deyaa Shaheen, Dhaval H Patel, Diane L Raccasi, Dipesh K Shah, Doan T Nguyen, PharmD, Dolores Harper, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald L Lech, Dongping Dai, PhD, Donna Ltartaglino Besone, Douglas A Campbell, Douglas C Kovacs, Dov H Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Gopa Biswas, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Willie Wilson, PhD, Dr. Zhihao Qiu (Peter), PhD, Eddie A Santini, Edmund F Mrak, Jr, Edwin Martinez, Edwin Melendez, Edwin Ortega, Eileen A Liu, Elena Karnaukhova, PhD, Eliezar Ramos, Elizabeth B Griffin, Emest F Bizjak, Emily A Baldwin, Emily J Orban, Eric M Mueller, PharmD, Erika E Englund, PhD, Erika V Butler, Erin D Mccaffery, Felix Maldonado, Frances L Dejesus, Francis A Guidry, Frank W Perrella, Freddy Ortiz Colon, Frederick F Razzaghi, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Geraldine D Sanders, German Rivera, Gilbert T Salud, Gloria E Parra, Gregson A Joseph, Guerlain Ulysse, Gwyn G Dickinson, Hai Lient Phung, Hala L Selby, Hasan A Irier, PhD, Hector Espinet, Hector Jcolon Torres, Hector M Fuste, Helen B Ricalde, Himanshu Gupta, PhD, Holly Brevig, Hugh M Mcclure, II, Ibad U Khan, Iraida Ortiz, Iris C Macinnes, Israel Santiago, OCM, Ivis L Negron, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, Jaime E Pares, James A Beaulieu, James A Lane, James A Liubicich, James C Maclaughlin, James D Bridges, James D Planchon, James I Giefer, James L Dunnie, Jr, James P Mcevoy, James R Birkenstamm, James R Evans, James R Montero, James S Cartwright, James W Plucinski, Janet A Rajan, Janete F Guardia, Jared P Stevens, Jason F Chancey, Jason K Morgan, Javier O Vega, Jawaid Hamid, Jeffery A Hangartner, Jeffery B Medwid, PhD, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey P Raimondi, Jennifer D Hollstrom, Jennifer L Gustavus, Jennifer L Schmidt, Jennifer Lalama, Jennifer M Gogley, Jeremy W Rotton, Jerri Baker, Jessica L Pressley, Jie He, Joan M Cantellops Figueroa, Joanne E King, Jocelyn E Massey, Joey V Quitania, Jogy George, John A Gonzalez, John P Mistler, Jonah S Ufferfilge, Jonathan G Matrisciano, Jonee J Mearns, Jorge E Martinez, Jorge L Gonzalez, Jorge L Guadalupe, Jorge L Lajara, Jose A Lopez, Jose A Moreno, José E Meléndez, Jose F Pedro, Jose Ohernandez Guzman, Jose Perez Soto, Jose R Hernandez, Jose R Lopez, Jose Rflores Veguilla, Jose Velez, Joseph F Owens, Joseph Kutze, PhD, Joseph R Haynes, Joseph R Lambert, Joshua J Silvestri, Joshua P Wireman, Juan Rjimenez Garcia, Julianne C Mccullough, Julie D Bringger, June P Page, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Kara D Dobbin, Karen E D'orazio, Karen L Kosar, Karen M Cooper, Kari M Johansen, Karishma G Gopaul, Karl D Hezel, Katherine D Adams, Katherine E Jacobitz, Katherine Szestypalow, Kathleen D Culver, Kathy E Noe, Kellia N Hicks, Kellie Leveille, Kelly I Anderson, Kenneth G Klobus, Kenneth H Williams, Kent A Conforti, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kevin P Regan, Kham Phommachanh, Khunnathee Stoner, Kim Lthomas Cruse, Kimberley A Hoefen, Kimberly Lewandowski Walker, Kip J Hanks, Kirsten L Vadheim, PhD, Ko U Min, Kristen D Evans, Kristina L Conroy, Kristy A Zielny, Kumar G Janoria, Laiza V Garcia, Lance Mde Souza, MBA, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laura E Garcia, Laura Fontan, MS, Laura I Salazar, PhD, Lauren L Vajo, Lauren N Howard, Lauren N Smith, Laurie B Frazier, Laurimer Kuilan Torres, Lawrence J Stringer, LCDR Angelica M Chica, LCDR Chad N Thompson, LCDR Debra Emerson, Lei Zhang, PhD, Lequita M Mayhew, Leslie A Mendoza, Libia M Lugo, Linda F Murphy, Linda K Matheny, Linda R Kuchenthal, Linda Thai, Lindsey M Schwierjohann, Lisa Hayka, Lisa Hornback, Lisa L Flores, Lisa M Bellows, Lisa M Lopez, Lisa R Hilliar, Lisa R Whitt, Lloyd D Payne, Lois K Gross, Lori A Carr, Lori B Wikstrom, Lori M Newman, Lori Wikstrom, Lourdes Andujar, LT Rafael Gonzalez, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis A Carrion, Luis A Dasta, Luis Mburgos Medero, Luis Soto Lopez, Luz N Riveradecruz, Lydia I Rosas Marty, Madushini Dharmasena, PhD, Mahesh Ramanadham, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marcus A Ray, Margaret L Bolte, Margaret M Annes, Margarita Santiago, Maria A Ruttell, Maria Cecilia Tami, PhD, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Maria V Price, Marian E Ramirez, Marianela Aponte Cruz, Maribel V Juarbe, Maricelys Mercado, Marie A Fadden, Marie B Buen Bigornia, Marie F Morin, Marilyn Santiago, Marion Michaelis, Marisol Faberlle, Mark D Johnson, Mark E Parmon, Mark R Mcclain, Marlene G Swider, Marlene Rodriguez Colon, Marvin D Jones, Mary E Farbman, PhD, Massoud Motamed, Matt D Suedkamp, Matthew A Spataro, Matthew B Casale, Maxwell Van Tassell, PhD, Medina, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melissa D Ray, Melissa J Garcia, Meyer J Slobotsky, Michael A Charles, Michael A Taylor, Michael D Smedley, Michael E Maselli, Michael J Kuchta, Michael L Casner, Michael L Chasey, Michael Levin, Michael Levy, Michael R Dominick, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michael Y Philopoulos, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle Yclark Stuart, Miguel A Martinez Perez, Miguel Gmanzano Maldonado, Miguel Hernandez Sanchez, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milva E Melendez Perales, Min Tang, Mindy M Chou, Minh D Phan, Mohsen Rajabi Abhari, FDA, Monica Cburgos Garcia, Monica E Caphart, Monica E Murie, Monica M Mcclure, Moraima Jramos Valle, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Mra V Millarw, Muna Algharibeh, Muralidhara B Gavini, PhD, Muralidhara D Givani, Myriam M Sosa, Nadeem I Chaudhry, Nancy F Scheraga, Nancy G Schmidt, Nancy L Rolli, Nancy M Espinal, Nancy N Bellamy, Nayan J Patel, Neal L Adams, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Nicholas L Paulin, Nicholas Obiri, PhD, Nicole E Knowlton, Nicole K Trudel, Niketa Patel, Nikki S Ramirez, Nikolay Spiridonov, Nimmy Mathews, Noreen Muñiz, Norman Wong, Nydia E Colon, Omotunde O Osunsanmi, Pablo Feliciano, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia A Mcilroy, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Mouris, Paul R Whitby, Paul Z Balcer, Paula A Trost, Perry H Gambrell, Perry T Nichols, Peter R Lenahan, Philip F Istafanos, DMV, MS, Prabhu P Raju, Prajakta A Varadkar, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qin Xu, Rachel A Peters, Rafael E Arroyo, Rafael Nevarez Nieves, Ralph A Erickson, Ralph H Vocque, Ram Sihag, PhD, Ramesh Potla, PhD, Ramon A Hernandez, Ramon E Martinez, Randy L Clarida, Raquel Gonzalez Rivera, Raymond T Oji, Reba A Gates, Rebeca M Melendez, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard E Needham, Richard H Penta, Richard Heath Coats, Richard K Vogel, Richard Ledwidge (nmi), PhD, Richard W Thornton, Richmond K Yip, Riley C Myers, PhD, Rita K Kabaso, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Ham, Robert J Martin, Robert Jennings, Robert M Barbosa, Rochelle K Kimmel, Rochelle L Cross, Rodney G Raiford, Rose Ashley, Rose Xu, Roy R Rinc, Russell J Glapion, Ruth A Williams, Saied A Asbagh, Saleem A Akhtar, Salvatore N Randazzo, Samantha J Bradley, Samina S Khan, Samuel T Walker, Sandra A Boyd, Sandra A Hughes, Sandra D Thompson, Sang Bong Lee, Sangeeta M Khurana, PhD, Santos E Camara, Sarah E Mcmullen, Sarmistha Sanyal, PhD, Satheesh Thomas, Scott B Laufenberg, Scott N Lim, Scott T Ballard, Sean R Marcsisin, Sena G Dissmeyer, Seneca D Toms, Sergey S Akimov, Sharon K Thoma, PharmD, Shawn Gould, Shirley J Berryman, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sneha S Patel, Sonia M Monges, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacie A Woods, Stephanie A Slater, MS, Stephanie D Crockett, Stephen D Brown, Stephen D Eich, Stephen E Langille, Stephen J Koniers, Steven A Gonzales, Steven B Barber, Steven C Madzo, Steven D Kehoe, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Suchan Kim, Sue Lee Chan, Susan F Laska, MS, Susan M Jackson, Susan O Oladeji, Susan P Bruederle, Susan T Hadman, Susanna E Ford, Susanne M Richardson, MS RAC, Suzanne N Vallez, Suzanne Vallez, Sylvia A Craven, Taichun Qin, PhD, Tajah L Blackburn, Tamara J Umscheid, Tamara M Casselman, Tamil Arasu, PhD, Tara G Bizjak, Tara K Carmody, Tara R Gooen, Tawny L Colling, Ted L Anderson, Temar Q Williams, Tenzin Jangchup, Teresa I Navas, Teresa Jimenez, Terri L Dodds, Thai T Duong, Theresa Kirkham (NMI), Thomas E Friel, Thomas J Arista, Thomas W Nojek, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiffani D Wilson, Timothy T Kapsala, Timothy Wadkin, PhD, Tina M Pawlowski, Todd M Stankewicz, Tonia F Bernard, Tonya R Johnson, Torrance J Slayton, Tracey L Harris, Truong Xuan Nguyen (Andy), Ucheabuchi Cchudi Nwankwor, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Valerie L Whipp, Victor J Gangi, Vilmary Negron Rodriguez, Vincent Thomas, Vioela J Caze, Vitaliy N Guyvan, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wanda J Torres, Warren J Lopicka, Wayne D Mcgrath, Wayne E Seifert, Wayne T Smith, Wendy G Tan, PhD, William J Leonard, Xianghong Jing (Emily), PhD, Xiaokuang Lai, PhD, Xiomara Copeland, Yanming An, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yong Hu, Youkeun Kim, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhao Wang, PhD, Zhaoyang Meng, Zhong Li, PhD, Zhongren Wu

Jose Acruz Gonzalez's Documents

Publish Date Document Type Title
October, 2003 FDA 483 Response Moehs Catalana SL - Form 483R, 2003-11-27
October, 2000 FDA 483 Novartis Pharma AG - Form 483, 2000-10-30
October, 2004 FDA 483 Response Bayer AG - Form 483R, 2004-11-17
February, 2017 FDA 483 Fidelio Healthcare Limburg GmbH - Form 483, 2017-02-02
February, 2006 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2006-02-08
May, 2005 EIR Charles River Laboratories Edinburgh Ltd. - EIR, 2005-05-13
September, 2019 FDA 483 Advanced Accelerator Applications (Italy) srl - Form 483, 2019-09-03
February, 2002 EIR Contract Pharmaceuticals Limited Canada - EIR, 2002-02-20
September, 2017 FDA 483 Les Produits Chimiques B.G.R. Inc. - Form 483, 2017-09-27
December, 2018 FDA 483 EUGIA PHARMA SPECIALITIES LIMITED - Form 483, 2018-12-14
December, 2003 FDA 483 Bristol Myers Squibb Caribbean Company - Form 483, 2003-12-17
December, 2005 EIR Viatris Pharmaceuticals LLC - EIR, 2005-12-13
May, 2009 FDA 483 APP Pharmaceuticals, LLC. - Form 483, 2009-05-28
November, 2006 FDA 483 Boehringer Ingelheim Animal Health Puerto Rico LLC - Form 483, 2006-11-17
April, 2012 FDA 483 Lilly del Caribe, Inc. - Form 483, 2012-04-04
September, 2002 EIR Pfizer Pharmaceutical Llc. - EIR, 2002-09-18
March, 2011 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2011-03-28
May, 2009 FDA 483 Ortho Biologics LLC - Form 483, 2009-05-04
March, 2010 FDA 483 Fenwal International, Inc. - Form 483, 2010-03-23
April, 2014 FDA 483 Patheon Italia S.p.A - Form 483, 2014-04-08
April, 2016 FDA 483 Rechon Life Science AB - Form 483, 2016-04-29
May, 2014 FDA 483 AbbVie Ltd - Form 483, 2014-05-20
July, 2010 FDA 483 YUKI GOSEI KOGYO CO., LTD. - Form 483, 2010-07-21
September, 2014 FDA 483 Sanofi S.r.l. - Form 483, 2014-09-26
March, 2000 EIR Bristol-Myers Squibb Manufacturing Company - EIR, 2000-03-21
April, 2019 EIR Baxter Healthcare Pty Ltd - EIR, 2019-04-09
October, 2004 EIR Bayer AG - EIR, 2004-11-24
March, 2007 FDA 483 Janssen Ortho LLC - Form 483, 2007-03-12
October, 2000 FDA 483 Novartis Pharma S.A. - Form 483, 2000-10-26
July, 2003 FDA 483 Mayne Pharma (PR) Inc. - Form 483, 2003-07-17
August, 2016 FDA 483 EUGIA PHARMA SPECIALITIES LIMITED - Form 483, 2016-08-05
September, 2007 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2007-09-07
June, 2018 FDA 483 ALFASIGMA SPA - Form 483, 2018-06-21
November, 2015 FDA 483 TAPI Puerto Rico, Inc. - Form 483, 2015-11-20
October, 2000 EIR Novartis Pharma AG - EIR, 2000-10-30
October, 2018 FDA 483 MSD International GmbH (Singapore Branch) - Form 483, 2018-10-12
March, 2009 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2009-03-25
October, 2003 FDA 483 MOEHS Catalana, S.A. - Form 483, 2003-10-24
July, 2014 FDA 483 AbbVie Biotechnology LTD - Form 483, 2014-07-16
February, 2008 FDA 483 Warner Chilcott Company, LLC - Form 483, 2008-02-05
March, 2007 FDA 483 INyX USA, Ltd. - Form 483, 2007-03-22
May, 2012 FDA 483 MUSTAFA NEVZAT ILAC SANAYI A S - YENIBOSNA SUBESI - Form 483, 2012-05-03
September, 2003 EIR OMJ Pharmaceuticals, Inc. - EIR, 2003-09-29
March, 2015 FDA 483 Fenwal International, Inc. - Form 483, 2015-03-25
November, 2016 FDA 483 FAREVA Unterach GmbH - Form 483, 2016-11-11
February, 2002 FDA 483 Contract Pharmaceutical Limited - Form 483, 2002-02-20
May, 2017 FDA 483 Fareva Amboise - Form 483, 2017-05-16
April, 2000 EIR OMJ Pharmaceuticals, Inc. - EIR, 2000-04-18
June, 2018 FDA 483 Janssen Pharmaceutica NV - Form 483, 2018-06-12
October, 2000 EIR Novartis Pharma Ag - EIR, 2000-10-19
August, 2014 EIR Patheon Puerto Rico, Inc. - EIR, 2014-08-11
August, 2013 FDA 483 Biogen MA Inc. - Form 483, 2013-08-02
September, 2014 FDA 483 GE Healthcare Ireland Limited - Form 483, 2014-09-15
August, 2003 FDA 483 A. Ochoa Distributors, Inc. - Form 483, 2003-08-26
May, 2002 EIR Lilly Del Caribe, Inc. - EIR, 2002-05-13
October, 2003 FDA 483 Towa Pharmaceutical Europe, S.L. - Form 483, 2003-10-29
October, 2012 FDA 483 Xellia Pharmaceuticals ApS - Form 483, 2012-10-16
June, 2009 FDA 483 OMJ Pharmaceuticals, Inc. - Form 483, 2009-06-11
January, 2011 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2011-01-26
October, 2003 FDA 483 Antibiotics SA - Form 483, 2003-10-22
April, 2017 FDA 483 Polimeros y Servicios S.A. - Form 483, 2017-04-05
February, 2019 FDA 483 Ajinomoto Co., Inc. - Form 483, 2019-02-22
April, 2019 FDA 483 ANSTO - Form 483, 2019-04-17
February, 2017 FDA 483 Buchler GmbH - Form 483, 2017-02-16
September, 2006 FDA 483 Bristol Myers Squibb Caribbean Company - Form 483, 2006-09-08
August, 2002 FDA 483 Bristol-Myers Squibb Manufacturing Company - Form 483, 2002-08-01
August, 2013 FDA 483 INDOCO REMEDIES LIMITED - Form 483, 2013-08-30
January, 2014 FDA 483 Boehringer Ingelheim Animal Health Puerto Rico LLC - Form 483, 2014-01-28
January, 2016 FDA 483 Oishi Koseido Co., Ltd. - Form 483, 2016-01-29
December, 2005 FDA 483 Viatris Pharmaceuticals LLC - Form 483, 2005-12-13
April, 2015 FDA 483 CENEXI - Form 483, 2015-04-28
January, 2010 FDA 483 AbbVie Ltd - Form 483, 2010-01-21
September, 2011 FDA 483 Response Viatris Pharmaceuticals LLC - Form 483R, 2011-11-02
September, 2019 FDA 483 CORDEN PHARMA CHENÔVE - Form 483, 2019-09-13
May, 2018 FDA 483 UBI Pharma Inc. - Form 483, 2018-05-04
April, 2000 FDA 483 Response OMJ Pharmaceuticals, Inc. - Form 483R, 2000-05-03
May, 2017 EIR Fareva Amboise - EIR, 2017-05-16
April, 2005 FDA 483 Janssen Ortho LLC - Form 483, 2005-04-13
May, 2005 FDA 483 Response Charles River Laboratories Edinburgh Ltd. - Form 483R, 2005-06-20
March, 2003 EIR Bristol Myers Squibb Caribbean Company - EIR, 2003-03-31
March, 2008 FDA 483 AbbVie Ltd - Form 483, 2008-03-19
September, 2012 FDA 483 Gland Pharma Limited - Form 483, 2012-09-07
July, 2015 FDA 483 Viatris Pharmaceuticals LLC - Form 483, 2015-07-02
November, 2019 FDA 483 MSN LABORATORIES PRIVATE LIMITED - Form 483, 2019-11-15
September, 2003 FDA 483 OMJ Pharmaceuticals, Inc. - Form 483, 2003-09-29
December, 2006 FDA 483 Ortho Biologics LLC - Form 483, 2006-12-07
April, 2019 FDA 483 Response Baxter Healthcare Pty Ltd - Form 483R, 2019-04-30
July, 2005 FDA 483 Knoll LLC - Form 483, 2005-07-18
October, 2003 EIR Towa Pharmaceutical Europe, S.L. - EIR, 2003-12-22
July, 2013 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2013-07-16
May, 2002 FDA 483 Lilly Del Caribe, Inc. - Form 483, 2002-05-13
November, 2014 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2014-11-11
October, 2003 FDA 483 Response ADL BIOPHARMA SL. - Form 483R, 2003-11-21
September, 2015 FDA 483 KYJ Medical Products Co., Ltd. - Form 483, 2015-09-24
October, 2002 FDA 483 Compania Cervecera de Puerto Rico, Inc. - Form 483, 2002-10-22
July, 2008 FDA 483 Janssen Ortho LLC - Form 483, 2008-07-17
August, 2009 FDA 483 Strides Pharma, Inc - Form 483, 2009-08-07
September, 2002 FDA 483 Response Pfizer Pharmaceutical Llc. - Form 483R, 2002-10-10
August, 2013 FDA 483 Somerset Therapeutics Limited - Form 483, 2013-08-20
August, 2018 FDA 483 Antibioticos do Brasil Ltda - Form 483, 2018-08-28
August, 2014 FDA 483 Patheon Puerto Rico, Inc. - Form 483, 2014-08-11
August, 2012 FDA 483 Fresenius Kabi Oncology Limited - Form 483, 2012-08-28
December, 2003 EIR Bristol Myers Squibb Caribbean Company - EIR, 2003-12-17
February, 2019 FDA 483 Otsuka Pharmaceutical Co Ltd - Form 483, 2019-02-15
April, 2016 FDA 483 Aspen SA Sterile Operations (Pty) Ltd - Form 483, 2016-04-19
February, 2013 FDA 483 Ortho Biologics LLC - Form 483, 2013-02-14
September, 2001 FDA 483 OMJ Pharmaceuticals, Inc. - Form 483, 2001-09-14
June, 2011 FDA 483 Novel Laboratories, Inc. - Form 483, 2011-06-29
February, 2010 FDA 483 Viatris Pharmaceuticals LLC - Form 483, 2010-02-08
August, 2005 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2005-08-31
March, 2015 EIR Fenwal International, Inc. - EIR, 2015-03-25
June, 2019 FDA 483 INDOCO REMEDIES LIMITED - Form 483, 2019-06-04
April, 2019 FDA 483 Baxter Healthcare Pty Ltd - Form 483, 2019-04-09
August, 2017 FDA 483 MFCI (Huanggang) Co., Ltd. - Form 483, 2017-08-17
November, 2014 EIR Boehringer Ingelheim RCV GmbH & Co KG - EIR, 2014-11-11
May, 2003 FDA 483 Bristol-Myers Squibb Manufacturing Company - Form 483, 2003-05-09
July, 2012 EIR AbbVie Biotechnology LTD - EIR, 2012-07-12
September, 2007 FDA 483 Knoll LLC - Form 483, 2007-09-14
January, 2013 FDA 483 MSD International GMBH Puerto Rico Branch LLC - Form 483, 2013-01-24
January, 2015 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2015-01-23
October, 2004 FDA 483 Bayer AG - Form 483, 2004-10-22
September, 2001 EIR OMJ Pharmaceuticals, Inc. - EIR, 2002-03-19
August, 2004 EIR INyX USA, Ltd. - EIR, 2004-08-19
October, 2012 EIR Xellia Pharmaceuticals ApS - EIR, 2012-10-16
April, 2000 FDA 483 OMJ Pharmaceuticals, Inc. - Form 483, 2000-04-18
July, 2013 EIR Pfizer Pharmaceuticals LLC - EIR, 2013-07-16
July, 2014 EIR AbbVie Biotechnology LTD - EIR, 2014-07-16
October, 2003 EIR ADL BIOPHARMA SL. - EIR, 2003-11-26
October, 2000 FDA 483 Novartis Pharma AG - Form 483, 2000-10-19
May, 2003 EIR Bristol-Myers Squibb Manufacturing Company - EIR, 2003-05-09
June, 2019 FDA 483 CAPLIN STERILES LIMITED - Form 483, 2019-06-14
November, 2002 EIR Senn Chemicals AG - EIR, 2002-11-21
April, 2005 EIR Janssen Ortho LLC - EIR, 2005-04-13
September, 2015 FDA 483 Hainan Hailing Chemipharma Corporation Limited - Form 483, 2015-09-18
February, 2005 FDA 483 Boehringer Ingelheim Animal Health Puerto Rico LLC - Form 483, 2005-02-16
November, 2002 FDA 483 Response Senn Chemicals AG - Form 483R, 2002-12-20
September, 2002 FDA 483 Pfizer Pharmaceutical Llc. - Form 483, 2002-09-18
March, 2014 FDA 483 AstraZeneca AB - Form 483, 2014-03-28
August, 2006 EIR Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - EIR, 2006-08-07
October, 2000 FDA 483 Confarma AG - Form 483, 2000-10-31
September, 2017 FDA 483 Olds Softgels, Inc. - Form 483, 2017-09-21
November, 2002 FDA 483 Senn Chemicals AG - Form 483, 2002-11-21
December, 2017 FDA 483 PANACEA BIOTEC PHARMA LIMITED - Form 483, 2017-12-13
April, 2008 EIR AstraZeneca AB - EIR, 2018-05-08
October, 2003 EIR Moehs Catalana SL - EIR, 2003-12-09
January, 2013 EIR MSD International GMBH Puerto Rico Branch LLC - EIR, 2013-01-24
June, 2006 FDA 483 Bristol-Myers Squibb Manufacturing Company - Form 483, 2006-06-15
May, 2017 FDA 483 Casmara Cosmetics, S.A. - Form 483, 2017-05-31
September, 2011 FDA 483 Viatris Pharmaceuticals LLC - Form 483, 2011-09-23
February, 2002 FDA 483 Response Contract Pharmaceuticals Limited Canada - Form 483R, 2002-04-02
February, 2016 FDA 483 Otsuka Pharmaceutical Co Ltd - Form 483, 2016-02-12
August, 2006 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2006-08-07
August, 2006 FDA 483 Patheon Puerto Rico, Inc. - Form 483, 2006-08-31
November, 2016 FDA 483 Teva Canada Limited - Form 483, 2016-11-18
March, 2019 FDA 483 Astellas Pharma Inc. - Form 483, 2019-03-05
February, 2017 FDA 483 R-Pharm Germany GmbH - Form 483, 2017-02-10
August, 2002 EIR Bristol-Myers Squibb Manufacturing Company - EIR, 2002-08-01
January, 2010 EIR AbbVie Ltd - EIR, 2010-01-21
May, 2014 EIR AbbVie Ltd - EIR, 2014-05-20
March, 2006 FDA 483 Fenwal International, Inc. - Form 483, 2006-03-13
August, 2013 EIR Biogen MA Inc. - EIR, 2013-08-02
July, 2012 FDA 483 AbbVie Biotechnology LTD - Form 483, 2012-07-12

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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