FDA Investigator Cynthia Jim, CSO

Cynthia Jim, CSO has conducted inspections on 261 sites in 24 countries as of 15 Apr 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
261
Last Inspection Date:
15 Apr 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Canada, United States of America, Sweden, India, France, Germany, Japan, Denmark, United Kingdom of Great Britain and Northern Ireland, Spain, Italy, Austria, Belgium, Australia, Curaçao, Hungary, Singapore, Netherlands, Switzerland, Mexico, China, Taiwan, Ireland, Iceland
FDA Investigators that have inspected at least one site in common with Cynthia Jim, CSO:
Abby Lmozeke Baker, Abdur Razzaque, Adam R Cooke, Ademola O Daramola, Adetutu M Gidado, Aditi S Thakur, Alan L Truong, Alan P Kurtzberg, Alanna L Mussawwir Bias, Albert F Peacock, PhD, Alberto A Viciedo, Alexey Khrenov, PhD, Alice C Silva, Alicia M Mozzachio, Alla Kachko, PhD, Alois P Provost, Amy A Johnson, Amy H Ruble, Amy Johnson, Ana P Barido, Anastasia G Lolas, Anastasia I Offordile, Anastasia M Shields, Andrew J Barrowcliff, Andrey Sarafanov, PhD, Andria L Kuhlman, Angela E Glenn, Angela Jourdain, Angela K Shen, Anissa M Cheung, Anita Narula, PhD, Anita R Michael, Anita Verma, Anjali Shukla, PhD, Ann L Demarco, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Annette A Ragosta, Anthony C Warchut, Anthony F Lorenzo, Anthony N Onianwa, Arie C Menachem, Arsen Karapetyan, Arthur S Williams, Jr, Ashley J Burns, Atul J Agrawal, Audrey Thereset Uy, Azza Talaat, Barbara J Holladay, Barbara J White, Barbara Janine Breithaupt, Barbara M Frazier, Barbara T Carmichael, Bijoy Panicker, Billy M Battles, Bingchen Du, PhD, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandy D Brown, Brent W Higgs, Brentley S Collins, Brian D Nicholson, Brian S Keefer, Brittany D Terhar, Bruce D Meade, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Carl Lee, Carla A Norris, Carla J Lundi, Carla R Hinz, Carlos M Gonzalez, Carmen Y Fisher, Carol L Rehkopf, Carolyn A Renshaw, Carolyn Yong, PhD, Caryn M Mcnab, Cassandra Overking, Cathleen A Carr Sharpe, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Chad R Burger, Chaltu Nwakijra, Chani Broner, PhD, Chao Ming Tsai, Charles I Ann, Charles R Bonapace, PhD, Charlotte Hinkle, Chen Sun, PhD, Cherrie A Zachary, Cherry R Valerio, Chiang Syin, PhD, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christina H Owens, Christina J Sauder, PhD, Christina V Santos, Christine A Harman, PhD, Christine M Parmentier, Christine M Whitby, CSO, Christine W Twohy, Christopher B May, Christopher J Adams, Christopher J Freebairn, Claire M Minden, Cody D Rickman, Concepcion Cruz, Jr, Connie L Hannon Rabel, Constance Y Fears, Craig D Zagata, Creighton T Tuzon, Cynthia A Harris, MD, RN, Cynthia J Lee, MS, Cynthia L Kelley, Cynthia M Goudeau, Cynthia White, Cynthia Whitmarsh, Daniel C Kearns, Daniel J Lahar, Daniel J Roberts, Daniel L Obrzut, Daniel Pst Laurent, Daniel R Azar, Daniel T Lee, Darin S Wiegers, Darla J Christopher, Daryl A Dewoskin, Dave Hafner, David E Bailey, David G Eng, David Galler Veety, David J Hafner, David K Lau, David L Chon, David L Duncan, David M Beltran, David S Cho, PhD, Deborah A Greco, Deborah J Parris, Deborah M Trout, Debra Bower, Debra J Bennett, Debra L Pagano, Decarlos A Gomez, Demario L Walls, Denise M Digiulio, Dennis Cantellops Paite, Derek C Price, Destry M Sillivan, Devaughn Edwards, Diana Kouiavskaia, Diane L Raccasi, Dinesh Kumar, Dino A Fiegelstock, Dipesh K Shah, Dmitriy V Volokhov, PhD, Dolores Harper, Don H Bark, PhD, Donald C Obenhuber, PhD, Donald L Lech, Dongping Dai, PhD, Douglas A Campbell, Douglas C Kovacs, Douglas F Frazier, Douglas J Frazier, Dr. Barbara D Paul, PhD, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Jun Liu, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie F Vann, PhD, Dr. Zhihao Qiu (Peter), PhD, Dr. Zhou Chen (nmi), MD PhD, Dustin P Tran, Dusty F Snoeberg, Edmund F Mrak, Jr, Edward Deberry, Eileen A Liu, Eileen J Bannerman, Elias N Paz Alonzo, Eliezar Ramos, Ellen Huang, Ellen P Madigan, Emest F Bizjak, Emily B Camire, Emmanuel Jramos Maldonado, Eric Peng, Erika V Butler, Erin C Hill, Erin D Mccaffery, Erin Hill (EH), Erin L Mcfiren, Erin M Mcdowell, Esra Toussaint, Esther C Broner, PhD, Eural E Porter, Ewa Marszal, PhD, Fabian Nchaparro Rodriguez, Felice D'agnillo, PhD, Felix Maldonado, Frank J Marciniak, Frank Wackes, Freddy Ortiz Colon, Frederick F Razzaghi, Frederick L Fricke, Fulton A Varner, Gabriel R Mclemore, Gam S Zamil, Gamal A Norton, Garrad R Poole, Gary J Hagan, Gayle S Lawson, Gene D Arcy, George A Prager, George Pyramides, Gerald B Seaborn, Jr, Gerald N Mcgirl, DDS, Gerard T Schneider, Gianine E Tompkins, Gideon N Esuzor, Gilbert T Salud, Ginger M Sykes, Gloria A Milster, Grace E Mcnally, Grace I Cortesini, Guerlain Ulysse, Guo Q Shen, Gwyn G Dickinson, Hai Lient Phung, Hailin Wang (Sheena), PhD, Haitao Li, Hala L Selby, Hanna L Potter, Haroon Vohra (NMI), Haruhiko Murata, Hector A Carrero, Helen B Ricalde, Helen R Bester, Helen Verdel, Henry K Lau, Holly Brevig, Hugh M Mcclure, II, Humberto Z Gomez, Ibad U Khan, Irina Gaberman, Isabel Y Espinosa, Ivan E Reyes, J David Doleski, Jacek Cieslak, PhD, Jacob M Dyer, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Crim, James C Maclaughlin, James E Keller, PhD, James I Giefer, James L Dunnie, Jr, James M Mason, James P Stallings, James P Stumpff, James R Evans, James W Plucinski, Janet L Bowen, Janet Pulver, Jared P Stevens, Jason F Chancey, Jason K Morgan, Javier E Santos, Jawaid Hamid, Jay Slater, MD, Jean Lhu Primmer, Jeanne J Thai, Jeffrey D Meng, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer A Baker, Jennifer D Hollstrom, Jennifer L Bridgewater, Jennifer L Reed, Jennifer L Schmidt, Jennifer M Gogley, Jessica Chery, Jessica L Pressley, Jie He, Joan A Loreng, Joan Adamo, Joan Johnson, Joanne E King, Joanne M Hajoway, Joanne Pryzbylik, Jocelyn C Turner, Joe X Phillips, Joel D Hustedt, Joey V Quitania, Jogy George, John D Finkbohner, PhD, John F Cipollo, John M Mcinnis, John M Mclnnis, John P Mistler, John S Hartford, John Stansberry, PhD, Jonathan B Lewis, Jonathan G Matrisciano, Jonathan Mclnnis, Jonathan R Campos, Joo Jin, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose R Hernandez, Joseph F Owens, Joseph George, Joseph Kutze, PhD, Joseph L Despins, PhD, Joseph R Lambert, Joshua J Silvestri, Joy Rkozlowski Klena, Joyce A Rockwell, Jude C Dikes, Julianne C Mccullough, Julie D Bringger, June P Page, Junho Pak, Justin A Boyd, Justine M Corson, Justine Tomasso, Jyoti B Patel, PhD, Kaarin M Slotte, Kalavati Suvarna, PhD, Kara D Dobbin, Karen A Coleman, Karen A Wolnik, Karen E D'orazio, Karen G Hirshfield, Karyn M Campbell, Katherine E Jacobitz, Katherine Szestypalow, Kathleen B Mihalik, Kathleen D Culver, Kathleen R Jones, PhD, Kathryn Carbone, MD, Kathy E Noe, Katie Harris, Katie L Penno, Kejun Cheng, Kellia N Hicks, Kelly D Moore, Kelly N Kerr, Kelly R Lewis, Kenneth H Williams, Kenneth M Gordon, Kenneth Nieves, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kim M Downing, Kimberley A Hoefen, Kimberly M Bigler, Kirsten L Vadheim, PhD, Kristen D Evans, Kristina J Donohue, Kristina Mjoyce Pittman, Kristy A Zielny, Kula N Jha, Kumar G Janoria, Kurt A Brorson, PhD, Lakisha M Williams, Lance Mde Souza, MBA, Lane V Christensen, PhD, Larry K Austin, Larry K Hampton, Latorie S Jones, Laura I Salazar, PhD, Laurel A Beer, Laurie B Frazier, Laurie P Norwood, Laurimer Kuilan Torres, Lawrence Carter, III, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Margaret Edi Gennaro, LCDR Matthew J Morrison, Lei Zhang, PhD, Lesley K Satterwhite, Leslie D Wagner, Lewis K Antwi, Li Yun Huang, Libia M Lugo, Liming Zhang, Linda F Murphy, Linda M Cheny, Linda R Kuchenthal, Linda Thai, Lindsey R Lyman, Lindsey S Fleischman, Lisa M Bellows, Lisa M Feola, Lisa M Parsons, Lisa P Oakes, Lloyd D Payne, Lois K Gross, Lori A Carr, Lori A Holmquist, Lori Peters, Lori S Lawless, Lourdes Valentin Aponte, LT Daveta L Bailey, LT John M Mastalski, Lu Deng, Lucas B Leake, Lucila B Nwatu, Luella J Rossi, Luis A Dasta, Luis Mburgos Medero, Lura D Baquero, Lydia I Rosas Marty, Lydia S Chan, Lynda L Perry, PhD, Lynette P Salisbury, Madushini Dharmasena, PhD, Malgorzata G Norton, PhD, Maotang Zhou, PhD, Marc A Alston, Marc A Jackson, Jr, Marcelo O Mangalindan, Jr, Marcus A Ray, Margaret L Bolte, Margaret M Annes, Margaret Norton, Maria Cecilia Tami, PhD, Maria Joselopez Barragan, PhD, Marian E Major, PhD, Marian Majors, PhD, Marie B Buen Bigornia, Marie F Morin, Marie T Falcone, Marion Michaelis, Marion W Nadeau, Mariza M Jafary, Mark A Elengold, Marla A Cassidy, Marlene G Swider, Marsha W Major, Martha T Olone, Mary E Farbman, PhD, Mary Jeanet Mcgarry, Mary P Padgett, Mary T Carden, Maryna C Eichelberger, PhD, Matthew A Spataro, Matthew C Watson, Megan A Haggerty, Mei Chiung Huang (Jo), Meihong Liu, Meisha R Sampson, Meisha Waters, Melanie M Walker, Melissa J Garcia, Melissa T Roy, Michael A Charles, Michael C Kennedy, PhD, Michael Curbarg, Michael D Kawalek, Michael E Maselli, Michael F Skelly, PhD, Michael Gurbarg, Michael J Kuchta, Michael J Vardon, Michael L Zimmerman, Michael Merchlinsky, Michael R Goga, Michael R Klapal, Michael S Araneta, Michael S Smoker, Michael Schmitt, Michael Shanks, MS, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle Yclark Stuart, Miguel A Martinez Perez, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Minh D Phan, Mitzi A Schwertfeger, Mizanne E Lewis, Mohammad Heidaran, PhD, Monica Cburgos Garcia, Monica J Wilkins, Morris Paul, Morris Sheldon, PhD, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Muna Algharibeh, Muralidhara B Gavini, PhD, Myra K Casey, Nancy F Scheraga, Nancy G Schmidt, Nancy Kirschbaum, PhD, Nancy L Neiger, Nancy T Waites, Natalya M Ananyeva, Nathan R Moon, Nawab A Siddiqui, Nayan J Patel, Nebil A Oumer, Nicholas A Violand, Nicholas M Smith, Nicholas Obiri, PhD, Nicholas R Nance, Nicole A Lloyd, Nicole E Knowlton, Nicole J Clausen, Nicole K Trudel, Niketa Patel, Nikisha M Bolden, Nimmy Mathews, Nobuko H Katagiri, Noreen Muñiz, Norman K Starks, Olga Simakova, PhD, Omotunde O Osunsanmi, Pankaj H Amin, Parul M Patel, Patricia A Brown, Patricia A Cortez, Patricia D Gardner, Patricia F Hudson, Patricia F Hughes, PhD, Patricia M Jacobs, Patrick C Klotzbuecher, Patsy J Domingo, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul W Keller, Paul W Moy, Paula A Trost, Peggy M Speight, Peng Zhou, Penny H Mccarver, Perry H Gambrell, Philip E Ake, Philip F Istafanos, DMV, MS, Philip J Snoy, Phillip M Pontikos, Pote Amin, Prabhu P Raju, Prajakta A Varadkar, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Qing Joanna Zhou, PhD, R Edwadebey Deberry, Rachael A Moliver, Rachel C Harrington, Rafael Padilla, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ram Sihag, PhD, Ramesh Potla, PhD, Ramjay Vatsan, PhD, Ramon A Hernandez, Ramon E Martinez, Randa Melhem, PhD, Randy L Clarida, Randy L Self, Randy V Bong, Raquel Gonzalez Rivera, Raymond W Brullo, Rebecca K Olin, Rebecca Rodriguez, Regina A Barrell, Regina T Brown, Reginald D Neal, Reyes Candau Chacon, PhD, Rhonda Alexander, Richard A Abate, Richard H Penta, Richard Heath Coats, Richard Jay Tucker, RS, Richard K Vogel, Richard L Friedman, Richard Ledwidge (nmi), PhD, Richard T Riggie, Richard W Thornton, Richmond K Yip, Ricki A Chase, Robert B Shibuya, MD, Robert C Coleman, Robert D Tollefsen, Robert J Martin, Robert Jennings, Robert L Hummel, Robert L Stevenson, Robert M Barbosa, Robert O'brian, Robert Sausville, Robert W Fisher, Robin Levis, PhD, Robin P Mathew, Rochelle K Kimmel, Roger F Zabinski, Roger L Farmer, Roman T Drews, PhD, Ronald E Lundquist, Ronald G Crawford, Ronald T Nowalk, Rory K Geyer, Rose Ashley, Rose Xu, Roy Baby, Russell J Glapion, Russell K Riley, Ruth A Williams, Ryan J Borges, Saleem A Akhtar, Salvatore N Randazzo, Samantha J Bradley, Samina S Khan, Sandra A Boyd, Sang Bong Lee, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah B Tanksley, Saundrea A Munroe, Scott C Lute, Scott E Norris, Scott R Nichols, PhD, Scott T Ballard, Sean P Desbrow, Sean R Marcsisin, Seneca D Toms, Sergey S Akimov, Shafiq S Ahadi, Sharmila Shrestha, Sharon K Thoma, PharmD, Shawn E Larson, Shawn R Gould, Sheila Dreher Lesnick, Sheldon Morris, Shelley H Beausoleil, Sheri L Stephenson, Sherry G Bous, Sheryl A Kochman, Shirley S Wen, Shirshendu K Deb, PhD, Shuang Tang, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Solomon Yimam (SY), Sony Mathews, Sonya M Edmonds, Stacey S Degarmo, Stefanie R Cook, Stephanie A Slater, MS, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen D Eich, Stephen T Hansen, Steve Y Rhieu, PhD, Steven A Rubin, Steven C Derrick, Steven C Madzo, Steven E Bowen, PhD, Steven E Kane, Steven Fong, MS, PhD, Steven M Weinman, Steven P Donald, Subramanian Muthukkumar, PhD, Susan A Zullo, PhD, Susan D Yuscius, Susan F Laska, MS, Susan M Jackson, Susan M Turcovski, Susan O Oladeji, Susan P Bruederle, Susan T Hadman, Susan Yu, Suzanne M Healy, Suzanne N Vallez, Swati Verma, Tamala P Bogan, Tamala P Magee, Tamara M Casselman, Tamika D Cathey, Tamil Arasu, PhD, Tammara A Newberry, Tammara A Stephens, Tammy L Chavis, Tara G Bizjak, Tara L Breckenridge, Tara L Greene, Ted L Anderson, Teena H Aiken, Tenzin Jangchup, Teresita C Mercado, Terri L Dodds, Terrig Thomas, PhD, Terry A Hook, DPh, Thaddeus M Steinke, Thai D Truong, Thai T Duong, Thanh M Andrews, Thao T Kwan, Theresa Kirkham (NMI), Theressa B Smith, Thomas A Peter, Thomas E Friel, Thomas J Arista, Thomas R Withers, Thunder N Dunkijacobs, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tim Lee, Timothy K Lee, PhD, Timothy M Martin, Tina Buecklein, Tina S Roecklein, Tonnie L Carter, Torrance J Slayton, Toyin B Oladimeji, Tracy J Washington, Travis S Bradley, Trinidad D Barreras, Truong Xuan Nguyen (Andy), Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Vashti E Bocker, Veronica Fuentes, MS, Veronica L Call, Vicky C Stoakes, Vijaya L Simhadri, Vilmary Negron Rodriguez, Vioela J Caze, Virgilio F Pacio, CSO, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wayne D Mcgrath, Wayne E Seifert, Wayne W Grundstrom, Wei Wang, PhD, Wella Wang, William D Tingley, William F Lagud, Jr, William H Sherer, Xiao Wang, Xiaokuang Lai, PhD, Xiaoping Guan, Xiuju Lu, Xu Michael Di, PhD, Yan Wang, Yangmin Ning, Yasamin Ameri, Yetao Jin, PhD, Yiping Jia, Yonggang Wang, PhD, Yongmin Liu, Yumi J Hiramine, Yun Wu, PhD, Yvins Dezan, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zakaria I Ganiyu, Ze Peng, Zhao Wang, PhD, Zhaoyang Meng, Zhijin Chen, Zhiping Ye, PhD, Zhong Li, PhD, Zhongren Wu, Zonglin Hu, Zuben E Sauna, PhD

Cynthia Jim, CSO's Documents

Publish Date Document Type Title
March, 2016 FDA 483 Bioreliance Ltd. - Form 483, 2016-03-23
September, 2009 FDA 483 Response Prothya Biosolutions Netherlands B.V. - Form 483R, 2009-10-05
September, 2017 FDA 483 Takeda Manufacturing Singapore Pte. Ltd. - Form 483, 2017-09-29
March, 2019 FDA 483 Response Sartorius Stedim Biooutsource Limited - Form 483R, 2019-03-06
October, 2011 FDA 483 Wyeth Farma SA - Form 483, 2011-10-12
October, 2017 FDA 483 CSL Behring (Australia) Pty Ltd - Form 483, 2017-10-16
January, 2010 FDA 483 Takeda Manufacturing Austria AG - Form 483, 2010-01-28
January, 2012 EIR Genzyme Flanders - EIR, 2012-01-24
October, 2014 FDA 483 OKC Allergy Supplies, Inc. - Form 483, 2014-10-17
March, 2011 FDA 483 Hospira Australia Pty Ltd - Form 483, 2011-03-21
February, 2004 FDA 483 Janssen Biotech, Inc. - Form 483, 2004-02-11
June, 2015 FDA 483 ID Biomedical Corporation of Quebec - Form 483, 2015-06-05
January, 2000 EIR Graham Pineo, M.D. - EIR, 2000-01-28
December, 2018 FDA 483 Grifols Therapeutics LLC - Form 483, 2018-12-13
January, 2000 FDA 483 Response Graham Pineo, M.D. - Form 483R, 2000-02-16
January, 2016 FDA 483 Takeda Manufacturing Italia SPA - Form 483, 2016-01-29
June, 2018 FDA 483 Sanofi Pasteur Inc. - Form 483, 2018-06-15
January, 2004 FDA 483 MassBiologics - Form 483, 2004-01-15
May, 2005 EIR Patheon Manufacturing Services LLC - EIR, 2005-05-12
September, 2006 FDA 483 Halo Pharmaceuticals Inc. - Form 483, 2006-09-28
April, 2015 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2015-04-17
May, 2000 FDA 483 Central Toxicology Laboratory - Form 483, 2000-05-05
May, 2012 FDA 483 ADMA Biologics, Inc - Form 483, 2012-05-17
January, 2000 FDA 483 Peter Lougheed Centre at Calgary General - Form 483, 2000-01-28
November, 2013 FDA 483 Greer Laboratories, Inc. - Form 483, 2013-11-15
October, 2013 FDA 483 Millipore (U.K.) Ltd. - Form 483, 2013-10-04
February, 2004 EIR Janssen Biotech, Inc. - EIR, 2004-02-11
June, 2022 FDA 483 PANACEA BIOTEC PHARMA LIMITED - Form 483, 2022-06-08
December, 2000 FDA 483 Coulston Foundation - Form 483, 2000-12-08
May, 2011 EIR Patheon Italia S.p.A - EIR, 2011-05-30
June, 2014 FDA 483 NAMSA - Form 483, 2014-06-11
October, 2019 FDA 483 Stason Pharmaceuticals, Inc. - Form 483, 2019-10-25
January, 2008 FDA 483 Immucor Inc - Form 483, 2008-01-17
March, 2005 FDA 483 Sanofi Pasteur Inc. - Form 483, 2005-03-18
April, 2018 EIR Valneva Scotland Ltd. - EIR, 2018-04-24
June, 2011 FDA 483 MERCK SERONO SA - Form 483, 2011-06-16
December, 2004 EIR AbbVie Bioresearch Center - EIR, 2006-12-20
April, 2012 FDA 483 Sanofi Pasteur - Form 483, 2012-04-02
November, 2007 FDA 483 Indivior Manufacturing LLC - Form 483, 2007-11-15
February, 2019 EIR Biogen MA Inc. - EIR, 2019-02-15
October, 2012 FDA 483 GlaxoSmithKline Biologicals SA - Form 483, 2012-10-05
September, 2009 FDA 483 Prothya Biosolutions Netherlands B.V. - Form 483, 2009-09-15
October, 2019 EIR Stason Pharmaceuticals, Inc. - EIR, 2019-10-25
June, 2012 FDA 483 OKC Allergy Supplies, Inc. - Form 483, 2012-06-27
July, 2014 EIR Emergent BioSolutions Canada Inc - EIR, 2014-07-18
September, 2009 EIR Prothya Biosolutions Netherlands B.V. - EIR, 2009-09-15
July, 2001 FDA 483 Derma Sciences Canada, Inc. - Form 483, 2001-07-26
February, 2012 FDA 483 CSL Behring AG - Form 483, 2012-02-02
November, 2009 EIR Alk-abello, Inc. - EIR, 2009-11-19
March, 2022 FDA 483 Alvotech Hf - Form 483, 2022-03-22
October, 2019 FDA 483 Response Stason Pharmaceuticals, Inc. - Form 483R, 2019-10-25
March, 2019 EIR Bioreliance Ltd. - EIR, 2019-03-15
October, 2016 FDA 483 Octapharma AB - Form 483, 2016-10-03
September, 2008 EIR Grifols Diagnostic Solutions Inc. - EIR, 2008-09-18
September, 2007 FDA 483 Boehringer Ingelheim RCV GmbH & Co KG - Form 483, 2007-09-18
October, 2011 FDA 483 Takeda Manufacturing Italia SPA - Form 483, 2011-10-20
August, 2015 EIR Greer Laboratories, Inc. - EIR, 2015-08-27
August, 2009 FDA 483 Baxter Healthcare Corporation - Form 483, 2009-08-19
February, 2008 FDA 483 Sanofi Pasteur - Form 483, 2008-02-15
May, 2005 FDA 483 Patheon Manufacturing Services LLC - Form 483, 2005-05-12
March, 2017 FDA 483 Instituto Grifols, S.A. - Form 483, 2017-03-24
March, 2018 EIR Merck Teknika LLC - EIR, 2018-03-22
March, 2020 FDA 483 Alembic Pharmaceuticals Limited - Form 483, 2020-03-13
August, 2015 FDA 483 Greer Laboratories, Inc. - Form 483, 2015-08-27
January, 2000 EIR Marquis, Dr. Jean Francois - EIR, 2007-04-03
November, 2009 FDA 483 Alk-abello, Inc. - Form 483, 2009-11-19
June, 2011 EIR MERCK SERONO SA - EIR, 2011-06-09
April, 2014 FDA 483 ID Biomedical Corporation of Quebec d/b/a/ GSK - Form 483, 2014-04-09
February, 2008 FDA 483 NAMSA - Form 483, 2008-02-21
September, 2008 FDA 483 Grifols Diagnostic Solutions Inc. - Form 483, 2008-09-18
February, 2008 FDA 483 Response Sanofi Pasteur - Form 483R, 2008-02-15
April, 2014 FDA 483 ID Biomedical Corporation of Quebec - Form 483, 2014-04-09
July, 2014 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2014-07-18
May, 2021 FDA 483 INDUSTRIA FARMACEUTICA GALENICA SENESE SRL - Form 483, 2021-05-04
June, 2011 EIR MERCK SERONO SA - EIR, 2011-06-16
October, 2022 FDA 483 Lupin Limited (Biotech Division) - Form 483, 2022-10-14
March, 2019 FDA 483 Bioreliance Ltd. - Form 483, 2019-03-15
February, 2018 FDA 483 Takeda Manufacturing Austria AG - Form 483, 2018-02-02
May, 2014 FDA 483 Sanofi Pasteur Inc. - Form 483, 2014-05-09
July, 2001 FDA 483 Response Derma Sciences Canada, Inc. - Form 483R, 2001-08-14
October, 2006 FDA 483 Allergan Sales, LLC - Form 483, 2006-10-27
January, 2007 EIR Grifols Diagnostic Solutions Inc. - EIR, 2007-01-23
January, 2017 FDA 483 GlaxoSmithKline Biologicals SA - Form 483, 2017-01-27
May, 2005 FDA 483 Response Patheon Manufacturing Services LLC - Form 483R, 2005-06-13
December, 2022 FDA 483 Japan Food Research Laboratories - Form 483, 2022-12-20
October, 2022 FDA 483 LUPIN LIMITED - Form 483, 2022-10-29
June, 2022 FDA 483 Immacule Lifesciences Private Limited - Form 483, 2022-06-20
May, 2017 FDA 483 GlaxoSmithKline Vaccines Srl - Form 483, 2017-05-29
March, 2019 EIR Sartorius Stedim Biooutsource Limited - EIR, 2019-03-06
March, 2018 FDA 483 Merck Teknika LLC - Form 483, 2018-03-22
December, 2022 FDA 483 Kyowa Kirin Co., Ltd. - Form 483, 2022-12-14
May, 2006 FDA 483 Seqirus Vaccines Limited - Form 483, 2006-05-26
February, 2023 FDA 483 NerPharMa S.r.l. - Form 483, 2023-02-20
July, 2017 FDA 483 California Stem Cell Treatment - Form 483, 2017-07-26
January, 2011 FDA 483 Octapharma AB - Form 483, 2011-01-20
July, 2018 FDA 483 ADIMMUNE CORPORATION - Form 483, 2018-07-30
June, 2011 FDA 483 MERCK SERONO SA - Form 483, 2011-06-09
July, 2018 FDA 483 Seqirus Pty Ltd - Form 483, 2018-07-17
July, 2005 FDA 483 Seqirus Vaccines Limited - Form 483, 2005-07-21
December, 2019 FDA 483 Medinatura New Mexico Inc. - Form 483, 2019-12-18
May, 2019 FDA 483 Sanofi Pasteur Limited - Form 483, 2019-05-24
January, 2000 FDA 483 Response Marquis, Dr. Jean Francois - Form 483R, 2000-02-18
January, 2015 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) - Form 483, 2015-01-20
July, 2019 FDA 483 ClinImmune Labs - Form 483, 2019-07-19
October, 2022 FDA 483 LUPIN LIMITED - Form 483, 2022-10-29
February, 2019 FDA 483 Biogen MA Inc. - Form 483, 2019-02-15
September, 2011 FDA 483 Emergent Biodefense Operations Lansing LLC - Form 483, 2011-09-09
March, 2011 FDA 483 Seqirus Pty Ltd - Form 483, 2011-03-31
February, 2004 FDA 483 Response Janssen Biotech, Inc. - Form 483R, 2004-03-10
March, 2004 FDA 483 Sanofi Pasteur - Form 483, 2004-03-18
May, 2011 FDA 483 Patheon Italia S.p.A - Form 483, 2011-05-30
June, 2013 FDA 483 SmithKline Beecham Pharma GmbH & Co. KG (dba GlaxoSmithKline Biologicals) - Form 483, 2013-06-27
April, 2018 FDA 483 Valneva Scotland Ltd. - Form 483, 2018-04-24
May, 2017 FDA 483 GSK Vaccines S.r.l. - Form 483, 2017-05-29
May, 2014 EIR Sanofi Pasteur Inc. - EIR, 2014-05-09
September, 2008 FDA 483 Response Grifols Diagnostic Solutions Inc. - Form 483R, 2008-09-18
June, 2001 EIR OCO Biomedical, Inc. - EIR, 2001-06-27
April, 2010 FDA 483 Emergent BioSolutions Canada Inc - Form 483, 2010-04-22
February, 2023 EIR NerPharMa S.r.l. - EIR, 2023-02-20
January, 2000 FDA 483 University of Ottawa Heart Institute - Form 483, 2000-01-21
July, 2018 FDA 483 Response ADIMMUNE CORPORATION - Form 483R, 2018-08-20
May, 2000 EIR Central Toxicology Laboratory - EIR, 2000-05-05
April, 2024 FDA 483 BIOLOGICAL E. LIMITED - Form 483, 2024-04-26

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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