FDA Investigator Jose Acruz Gonzalez

Jose Acruz Gonzalez has inspections in 38 countries as of 03 Nov 2023. Jose Acruz Gonzalez has collaborated with a combined 12370 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
289
Last Inspection Date:
03 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Mexico, United States of America, India, Australia, Sweden, France, Spain, Ireland, Aruba, Korea (Republic of), Denmark, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland, Japan, Germany, Italy, China, Hungary, Argentina, Austria, Belgium, Finland, Canada, Viet Nam, Singapore, Costa Rica, Brazil, Saudi Arabia, Taiwan, Slovakia, Norway, Serbia, Poland, Netherlands, South Africa, Latvia
Co-Investigator(s):
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 T Talaat, Azza Talaat, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara L Rogolsky, 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, Carlos Carlos, A Medina, Carol L Rehkopf, Carolyn A Renshaw, Carrie A Hughes, Caryn M Mcnab, Cassandra L Abellard, CDR Ileana Barreto Pettit, 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, 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, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald L Lech, Dongping Dai, PhD, Donna Ltartaglino Besone, Douglas A Campbell, Douglas C Kovacs, Dov 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, 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, Erik W Koester, 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 Razzaghi, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Geraldine D Sanders, German Rivera, Gilbert T Salud, Gloria E Parra, Gregson A Joseph, Gregson Joseph, Guerlain Ulysse, Gwyn G Dickinson, Hai Lien T Phung, Hala L Selby, Harperd, Hasan A Irier, PhD, Hector Espinet, Hector J Colon Torres, Hector M Fuste, Helen B Ricalde, Himanshu Gupta, PhD, Hugh M Mcclure, II, Ibad U Khan, Iraida Ortiz, Iris C Macinnes, Israel Santiago, OCM, Ivis L Negron, Ivis Lnegron Torres, 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, Jeffrey A Sommers, Jeffrey B Medwid, PhD, 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 Crest, Jose A Cruz, Jose A Lopez, Jose A Moreno, Jose Alopez Rubet, José E Meléndez, Jose E Melendez, DDC, Jose F Pedro, Jose Fpedrode Jesus, Jose Lpez, Jose Melendez, José Meléndez, Jose O Hernandez, Jose Perez Soto, Jose R Hernandez, Jose R Lopez, Jose Rflores Veguilla, Jose Rflores Vequilla, 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 M De 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 N Thai, Linda R Kuchenthal, Linda Thai, Lindsey M Schwierjohann, Lisa Hayka, Lisa Hornback, Lisa L Flores, Lisa M Bellows, Lisa M Lopez, Lisa R Whitt, Lloyd D Payne, Lois K Gross, Lori A Carr, Lori B Wikstrom, Lori M Newman, Lori Wikstrom, Lourdes Andajar, Lourdes Andujar, LT Rafael Gonzalez, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis A Carrion, Luis A Dasta, Luis M Burgos Medero, Luis Soto Lopez, Luis Soto López, Luz N Riveradecruz, Lydia Irosas Marty, M Patriciaurphy Murphy, 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 Bbuen Bigornia, Marie F Morin, Marilyn Santiago, Marion Michaelis, Marisal Faberhe, 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 Sparato, 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 Levine, 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 Y Clark Stuart, Miguel A Martinez, Miguel A Martinez Perez, Miguel G Manzano, Miguel Hernandez Sanchez, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milva E Melendez, Milva Emelendez 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 J Ramos Valle, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, 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, Nancy Sheraga, 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 Muniz, Noreen Muñiz, Norma Wong, Norman Wong, Nydia E Colon, Omotunde O Osunsanmi, Pablo Feliciano, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patricia A Mcilroy, Patricia Fhughes Troost, 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, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qin Xu, Rachel A Peters, Rafael E Arroyo, Rafael Nevarez, 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, 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 Martin, Robert M Barbosa, Robert Q Jennings, Robert W Jennings, Rochelle K Kimmel, Rochelle L Cross, Rodney G Raiford, Rose M 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, Satheesh Thomas, Scott B Laufenberg, Scott N Lim, Scott T Ballard, Sean R Marcsisin, Sena G Dissmeyer, Seneca D Toms, Sharon K Thoma, PharmD, Shawn Gould, Shirley J Berryman, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado, Sixto M Mercado Rios, Sixto Mercado Rios, Sneha S Patel, Sonia M Monges, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacie A Woods, State Agency, 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, Sue Lee Chan, Susan F Laska, MS, Susan M Jackson, Susan O Oladeji, Susan P Bruederle, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Suzanne N Vallez, Suzanne Vallez, Taichun Qin, PhD, Tajah L Blackburn, Tamara J Umscheid, Tamara M Casselman, Tamil Arasu, PhD, Tara G Bizjak, Tara K Carmody, Tara R Gooen, 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), Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie L Whipp, Victor J Gangi, Vilmary Negron Rodriguez, Vincent Thomas, Vioela J Caze, 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, Willie Wilson, 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, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu

Jose Acruz Gonzalez's Documents

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

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  • 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