FDA Investigator Simone E Pitts

Simone E Pitts has inspections in 24 countries as of 13 Nov 2023. Simone E Pitts has collaborated with a combinined 15991 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
247
Last Inspection Date:
13 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Ireland, Hong Kong, United Kingdom of Great Britain and Northern Ireland, Mexico, China, Canada, India, Spain, Netherlands, Japan, France, Germany, Italy, Denmark, Singapore, Belgium, Switzerland, Australia, Sweden, Poland, Israel, Argentina
Co-Investigator(s):
A Williams, Abdur Razzaque, Adaliz Santaliz Cruz, Ademola O Daramola, Aditi S Thakur, Aikaterini Alexaki, Alan L Brend, Alan P Kurtzberg, Alberto A Viciedo, Alexey Khrenov, PhD, Alia Legaux, Alice S Tsao, Alicia Gilbert, Alicia M Mozzachio, Alison N Stieg, Alla Kachko, PhD, Althea A Williams, Amanda B Athey, Amber D Brodas, Amy Hsu, PhD, Amy M Cramer, Amy W Mai, Amy W Yan Mai, Ana P Pineda Zavaleta, Ana S Cabrera, Anastasia I Offordile, Anastasia M Shields, Anders W Evenson, Andrew A Hoopes, Andrew A Leboeuf, Andrew Chang, Angela E Glenn, Angela K Shen, Anissa M Cheung, Anissa M Vargas, Anita R Michael, Ankur C Patel, Ann L Demarco, Ann M Stewart, Ann Marie Montemurro, Ann Marie Schofield, Anna Lazar, Anna M Alexander, Annemarie Bodnar, Anthony A Charity, Anthony C Warchut, Anthony F Lorenzo, Anthony N Onianwa, Anthony R Bucks, Antonina Aydanian, April L Young, Arduino Frankovic, Arie C Menachem, Ariel Cruz Figueroa, Arsen Karapetyan, Asamoah Asamoah, Ashar P Parikh, Ashley A Mutawakkil, Ashley J Burns, Ashley L Reiber, Ashley N Queen, PhD, Atul J Agrawal, Audrey Thereset Uy, Ava M Bowman, Aziz A Mamur, Azza Talaat, Barbara A Gullick, Barbara J Rincon, Barbara Janine Breithaupt, Barbara L Rogolsky, Barbara M Frazier, Barbara T Carmichael, Benjamin J Smith, Benton M Ketron, Betsy C Galliher, Bharat Khurana, Bijoy Panicher, Bijoy Panicker, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brandon L Mariner, Brandy N Lepage, Brenna L Macdowell, Brentley S Collins, Brett R Havranek, Brian D Nicholson, Brian D Rogers, Brian J Ryan, Brian L Belz, Brian R Yaun, Brian R Yuan, Brian S Keefer, Brittany D Terhar, Brooke K Higgins, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Camerson E Moore, Carl A Huffman, III, Carl Lee, Carla A Norris, Carla J Lundi, Carolyn Yong, PhD, Carrie L Doupnik, Caryn M Everly, Caryn M Mcnab, CDR Cecily Jones, CDR Donald Ertel, CDR Ileana Barreto Pettit, CDR Jeremy L Wally, PhD, CDR Sean T Creighton, Chad E Schmear, Chad R Burger, Chaltu N Wakijra, Chao Ming Tsai, Chaoying C Ma, Charanjeet Jassal, Charisse K Green, Charles I Ann, Charles J Chacko, Charles Jewell, Charles L Larson, Charles M Edwards, Charles M Spyr, Charlotte Hinkle, Chava Kimchi Sarfaty, PhD, Cheng H Yen, Cheryl A Clausen, Chiang Syin, PhD, Christian D Lynch (CDL), Christian Parra, Christina J Sauder, PhD, Christina K Theodorou, Christina V Santos, Christine A Harman, PhD, Christine W Twohy, Christopher D Leach, Christopher J Adams, Christopher R Czajka, Christopher S Fields, Christopher S Keating, Christopher T Middendorf, Christopher T Peters, Clinton J Lott, Clotia Cabbey Mensah, Cody D Rickman, Colleen M Aspinwall, Concepcion Cruz, Jr, Constantin Y Philopoulos, Craig D Zagata, Creighton T Tuzon, Cynthia J Lee, MS, Cynthia Jim, CSO, Cynthia Whitmarsh, D Jenny Argiropoulos, Dale A Nyberg, Damaris Y Hernandez, Dana A Razzano, Dandan Wang, PhD, Daniel J Lahar, Daniel J Roberts, Daniel Lagasse, Darin S Wiegers, Darla J Christopher, Darrell E Luedtke, Darren S Brown, Dave Hafner, David A Oluwo, David A Paterson, David H Smith, David J Eide, David J Gasparovich, David J Hafner, David K Glasgow, David M Beltram, David M Beltran, David Perkins, David R Delucia, Dawn L Wydner, Deborah A Greco, Deborah B Nixon, Deborah M Trout, Debra I Love, Debra J Bennett, Debra L Pagano, Demetria J Arpropractor, Demitria J Argiiropoulos, Demitria J Argiropolous, Demitria J Argiropoulos, Demitria J Xiradakis, Denise L Burosh, Denise M Digiulio, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Dennis L Doupnik, Dennis R Downer, Derek S Smith, PhD, Deyaa Shaheen, Diane C Thibodeau, Diane L Raccasi, Dianiris C Ayala, Dien N Nguyen, Dipesh K Shah, Donald C Obenhuber, PhD, Donald G Gordon, Donald L Myers, Dongping Dai, PhD, Donna Mwilliams Hill, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Dominick Roselle, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Robert C Horan, MD, Dr. Roslyn F Powers, Dr. Yubing Tang, Dwayne E Dollins, Edmund F Mrak, Jr, Edwin Melendez, Eileen A Liu, Ekaterina Allen, Elizabeth B Griffin, Ellen Huang, Elmina E Akwo, Emest F Bizjak, Emilie E Kahn, Emily J Orban, Enrico Joset Mangahis, Ephrem Hunde, PhD, Eric J Cunningham, Eric J Reisenauer, Eric L Dong, BS, Eric M Mueller, PharmD, Eric M Padgett, Eric S Pittman, Erica B Raphael, Erik W Koester, Erika E Englund, PhD, Erika V Butler, Erin L Nagel, Erk W Koester, Evan Tong, Evelyn Taha, Fabian Chaparro, Fabian Nchaparro Rodriguez, Farhana Khan, Fatima Bassa, Felix Maldonado, Francis A Guidry, Frank J Marciniak, Frank Verni, Freddy Ortiz Colon, Frederick Razzaghi, Freyja V Lynn, Gale E Ryan, Gam S Zamil, Gary J Hagan, Gary J Lehr, Gary T Greco, Gene D Arcy, George J Flynn, George Pyramides, Geraldine D Sanders, Geraldine Sanders, Gerard D Difiore, Gerardo Z Vazquez, German Rivera, Gifford Whitehurst, Jr, Ginger M Sykes, Gloria E Parra, Gray, Gregory R Dill, Gregson A Joseph, Gregson Joseph, Guerlain Ulysse, Guo Q Shen, Gwyn G Dickinson, Hala L Selby, Hamet M Toure, PharmD MPH, Harperd, Harry J Brewer, Haruhiko Murata, Hasan A Irier, PhD, Hector A Carrero, Hector J Colon Torres, Helen B Ricalde, Helen Y Saccone, Heriberto Negron Rivera, Holly M Scott, Huiquan Wu, Ifueko Osemwota, Iram R Hassan, PhD, Irina Gaberman, Israel Santiago, OCM, Ivis Lnegron Torres, J David Doleski, Jacqueline Mdiaz Albertine, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Jagon, James A Liubicich, James C Lee, PharmD, James C Maclaughlin, James D Bridges, James I Giefer, James K Ireland, James L Dunnie, Jr, James M Mason, James M Simpson, James Norman, James P Mcevoy, James P Mcreavey, James R Evans, James R Fleckenstein, James W Leonette, James W Plucinski, Jane Chen, Janet A Rajan, Janet B Abt, Janet L Bowen, Jazmine N Brown, Jazmine N Still, Jean Lhu Primmer, Jean M Kelahan, Jeanne M Morris, Jeffery A Hangartner, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey J Thibodeau, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer C Johnson, Jennifer L Bridgewater, Jennifer L Huntington, Jennifer L Schmidt, Jennifer M Menendez, Jennifer Macmillan, Jesse A Vazquez, Jessica L Pressley, Jessica S Estriplet, Jin Gao, Joan A Loreng, Joan A Loreno, Joan Adamo, Joanne E King, Joanne M Hajoway, Joanne M Schlossin, Joanne Pryzbylik, Joel D Hustedt, Joey V Quitania, Jog George, Jogy George, John A Podsadowski, John D White, John Dan, John M Mcinnis, John P Mistler, John S Hartford, John Stansberry, PhD, Johnna L Bleem, Jonah S Ufferfilge, Jonah Ufferfilge, Jonathan G Gayechuway, Jonathan G Matrisciano, Jonathan W Chapman, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose Martinez, Jr, Jose R Hernandez, Jose R Lopez, Joseph A Piechocki, Joseph George, Joseph J Vannelli, Joseph L Despins, PhD, Joseph Maselli, Joseph Milcetic, Joseph R Lambert, Joseph W Matthews, Joy P Matthias, Joyce A Rockwell, Juan Rjimenez Garcia, Judy Keihl, Juliana Falla, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Justine M Corson, Kalavati Suvarna, PhD, Kara D Dobbin, Karen E D'orazio, Karen Emasley Joseph, Karen L Kosar, Karen M Rodriguez, Karyn M Campbell, Katherine E Jacobitz, Katherine Szestypalow, Kathleen B Mihalik, Kathleen D Culver, Kathleen M Jordan, Kathryn Carbone, MD, Kathryn E Ogger, Katie L Penno, Kazi Rafiquzzaman, Kejun Cheng, Kelli F Dobilas, Kellia N Hicks, Kellie Leveille, Kelly I Anderson, Kelly K Nachtigal, Kelly N Kerr, Kelly R Lewis, Ken L Bowers, Kenneth Gordon, Kenneth H Williams, Kenneth M Gordon, Kenneth Nieves, Kerun Hardeo, Kevin A Gonzales, Kevin A Gonzalez, Kevin D Kallander, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kim M Downing, Kimberley A Ricketts, Kimberly M Bigler, Kimberly M White, Kimberly Y Smithson, Kinh Q Mac, Ko U Min, Kristen D Evans, Kristina J Donohue, Kristina L Conroy, Kristy A Zielny, Kwong P Lee, Kyran R Gibson, L Gnnmassimia Massimilla, PharmD, Larry K Austin, Lata C Mathew, PhD, Latorie S Jones, Laurel A Beer, Lauren L Vajo, Lauren M Lilly, PhD, Laurie B Frazier, Laurimer Kuilan Torres, Lawrence Harmon, Jr, Lawrence W Farina, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Margaret E Digennaro, LCDR Michael H Tollon, LCDR Randall L Morris, LCDR Susan E Polifko, Leena Thomas, Leonard H Lavi, Lequita M Mayhew, Lewis K Antwi, Li Hongpaul Yeh, PhD, Li Li, Li Yun Huang, Libia M Lugo, Linda F Murphy, Linda K Cline, Linda M Sacco, Linda Thai, Lindsey S Fleischman, Lirissia Mccoy, Lisa Feela, Lisa M Bellows, Lisa Relloos, Lorelei S Jarrell, Loretta Nemchik, Lori P Peters, Lori Peters, Lori S Lawless, Lorie S Hannappel, LT John M Mastalski, LT Tamara J Henderson, Lucas B Leake, Luella J Rossi, Luis A Dasta, Lydia Irosas Marty, Lynda L Perry, PhD, M Patriciaurphy Murphy, Madelyn Renteria, Madushini Dharmasena, PhD, Maksim A Levenchuk, Manhar R Patel, Marc S Neubauer, Marcellinus D Dordunoo, Marcus A Ray, Marcus F Yambot, Margaret A Smithers, Margaret E Sarles, Margaret L Bolte, Margaret M Annes, Margaret M Doherty, Margaret Torres Vazquez, Maria A Reed, Maria Joselopez Barragan, PhD, Marian E Major, PhD, Marianela Aponte Cruz, Marie A Fadden, Marie Elena C Puleo, Marie F Morin, Marion Michaelis, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark E Frank, Mark R Mcclain, Marlene L Davis, Marsha W Major, Martha T Olone, Martrice A Packer, Mary Davis Lopez, Mary M Finn, Mary T Carden, Marybet Lopez, Maryna C Eichelberger, PhD, Massoud Motamed, Mate Tolnay, Matthew A Spalazo, Matthew A Sparato, Matthew A Spataro, Matthew B Casale, Matthew C Watson, Matthew D Schnittker, Matthew J Johnson, Matthew M Henciak, Matthew M Schuckmann, Matthew R Dionne, Matthew R Sleeter, Maya M Davis, Megan A Haggerty, Meihong Liu, Meisha A Mandal, Meisha R Sampson, Meisha Waters, Melissa A Henaghan, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Mercy O Quagraine, Meredith P Soehl, Investigator, Meyer J Slobotsky, Michael A Charles, Michael C Kennedy, PhD, Michael Curbag, Michael E Maselli, Michael F Skelly, PhD, Michael Gurbarg, Michael J Vardon, Michael L Casner, Michael Levin, Michael Levine, Michael P Sheehan, Michael R Dominick, Michael R Goga, Michael R Klapal, Michael S Araneta, Michael Serrano, Michael Shanks, MS, Michael W Burd, Michael Y Philopoulos, Michele Gottshall, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle M Noe, Michelle Rfrazier Jessen, PhD, Miguel A Martinez, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milan S Blake, Milan S Mcgorty, Mindy M Chou, Mizanne E Lewis, Mohammad Heidaran, PhD, Mohsen Rajabi Abhari, FDA, Monica Cburgos Garcia, Monica E Caphart, Monica M Mcclure, Mra B Kamberem, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Mra Narulaa, Muralidhara B Gavini, PhD, Nadeem I Chaudhry, Nancy A Bellamy, Nancy A Saxenian Emmons, Nancy E Kirschbaum, Nancy G Schmidt, Nancy L Neiger, Nancy T Waites, Natalya M Ananyeva, Nealie C Newberger, Nebil A Oumer, Nicholas A Violand, Nicholas L Paulin, Nicholas Obiri, PhD, Nicholas P Diorio, Nicholas Z Lu, Nichole B Murphy, Nicole A Lloyd, Nicole E Knowlton, Nicole K Trudel, Niketa Patel, Nimmy Mathews, Noreen Muniz, Norman K Starks, Norman Wong, Omotunde O Osunsanmi, Osama A Khatib, Oumou Barry, Pal S Mayasandra, Pankaj H Amin, Paola S Barnett, Paraluman S Leonin, Parul M Patel, Patricia A Mcilroy, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul D Keller, Paul E Stein, Paul L Bellamy, Paul L Yeh, Paul Mouris, Paul W Keller, Paula A Trost, Paula R Katz, Pawan K Jain, Peng Zhou, Penny H Mccarver, Perez, Perry H Gambrell, Perry T Nichols, Peter E Baker, Peter M Trunk, Philip F Istafanos, DMV, MS, Philip Kreiter, Phung Thien Nguyen, Phyllis J Wilson, Prabhu P Raju, Prajakta A Varadkar, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Qin Xu, Rachael A Moliver, Rachael O Oyewole, Rachael Oyewole, Rachel C Harrington, Rachel T Evans, Rafael E Arroyo, Rafael Nevarez Nieves, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramon A Hernandez, Ramon E Martinez, Randa Melhem, PhD, Raquel Gonzalez Rivera, Raymond M Lam, Raymond T Oji, Reba A Gates, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Regina T Brown, Reginald D Neal, Reyes Candau Chacon, PhD, Richard A Abate, Richard D Manney, Richard H Penta, Richard Heath Coats, Richard J Friedman, Richard L Friedman, Richard L Rutherford, Richard W Thornton, Richmond K Yip, Ricki A Chase, Riley C Myers, PhD, Rita K Kabaso, Robert B Shibuya, MD, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert G Ruff, Robert H Wittorf, Robert J Ham, Robert J Maffei, Robert J Martin, Robert Jennings, Robert M Barbosa, Robert Mo Brien, Robert W Fisher, Robert W Jennings, Roberta W Cunningham, Robin Levis, PhD, Rochelle K Kimmel, Rochelle L Cross, Rodney G Raiford, Roger F Zabinski, Roman Drews, PhD, Roman T Drews, PhD, Rory K Geyer, Rosa J Motta, Rose J Motta, Rose M Ashley, Rose Xu, Ross J Grigsby, Roy Baby, Roy R Rinc, Rumany C Penn, PharmD, Russell J Glapion, Russell K Riley, S Thomas, Saied A Asbagh, Saleem A Akhtar, Sam Pepe, Samantha J Bradley, Samina S Khan, Samuel T Walker, Sandra A Hughes, Sandra D Thompson, Sangeeta M Khurana, PhD, Santiago Gallardo Johnson, Santos E Camara, Sarah A Meehan, Sarah B Tanksley, Sarah E Mcmullen, Sarah E Rhoades, Sarah Forney, Sarah Ibrahim, Sarah M Meng, Sarah M Napier, Satheesh Thomas, Scott A Golladay, Scott B Laufenberg, Scott E Norris, Scott T Ballard, Sean R Bryd, Seifert Seifert, Wayne E, Shafiq S Ahadi, Shannon A Gregory, Shari L Kahn, Sharmila Shrestha, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Shelby N Turner, Sherri N Rohlf, MD, Sherry G Bous, Sheryl A Kochman, Shirley H Isbill, Shirley J Berryman, Shirley S Wen, Shirshendu K Deb, PhD, Shuang Tang, Sidney B Priesmeyer, Simone E Pills, Simone Pins, Sixto M Mercado Rios, Sneha S Patel, Sonia R Peterson, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey S Degarmo, State Agency, Stella Yuen, Stephanie A Slater, MS, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen D Eich, Stephen R Souza, Steven A Gonzales, Steven A Rubin, Steven B Hertz, Steven C Madzo, Steven D Kehoe, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan Yu, Susanna E Ford, Analyst, Susant Hadman, Svetlana A Shestopal, Syeda N Mahazabin, Taichun Qin, PhD, Tamara Brey, Tamara M Simpson, Tamil Arasu, PhD, Tammy L Chavis, Tania Y Hall, Tara K Carmody, Tara L Breckenridge, Tara L Greene, Tarun D Mehta, Taruna Khurana, Ted L Anderson, Tej Poonai, Teresita C Mercado, Terri L Dodds, Terrig Thomas, PhD, Thao T Kwan, That Q Dang, Theresa Kirkham (NMI), Thomas E Friel, Thomas J Arista, Thomas J Mooney, Thomas R Withers, Thomas W Gordon, Thomas W Nerney, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiffani D Wilson, Timothy T Kapsala, Tina M Pawlowski, Tina S Roecklein, Todd M Stankewicz, Tonia F Bernard, Torrance J Slayton, Toyin B Oladimeji, Tracey L Harris, Tracy M Portelli, Tracy R Ball, Tricia S Martinez, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valentino Fiorella, Valerie J Grecek Trinh, Vanessa M Williams, Vesna V Stanoyevitch, Victoria M Daddeo, Vijaya L Simhadri, Vilmary Negron Rodriguez, Vincent M Williams, Viviana Matta, Vivin George, Vlada Matusovsky, Walden H Lee, Walsworth, Walter L Fava, Wanda Eng, Wanda Y Honeyblue, Wayne D Mcgrath, Wayne E Seifert, Wayne T Smith, Wei Wang, PhD, Wendy G Tan, PhD, William A Warnick, William J Leonard, Winston R Alejo, Xianghong Jing (Emily), PhD, Xiao Wang, Xiaohui Shen, Xiaokuang Lai, PhD, Xiaoping Guan, Yasamin Ameri, Yiping Jia, Yonggang Wang, PhD, Yumi J Hiramine, Yuyan Liang, Yvesna C Blaise, Yvette I Johnson, Yvins Dezan, Yvonne C Wilkes, Zabinski Zabinski, Roger F, Zachary A Bogorad, Ze Peng, Zhenzhen Liu, PhD, Zhihao Qiu (Peter), PhD, Zhongren Wu, Zi Qiang Gu, Zonglin Hu, Zuben E Sauna, PhD

Simone E Pitts's Documents

Publish Date Document Type Title
January, 2020 FDA 483 Response Hospira, Inc. - Form 483R, 2020-02-10
May, 2001 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2001-05-25
December, 2022 FDA 483 Amsino Healthcare (USA) Inc. - Form 483, 2022-12-19
June, 2019 FDA 483 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd - Form 483, 2019-06-14
September, 2023 FDA 483 Prime Enterprises - Form 483, 2023-09-01
June, 2003 EIR Axiom Pharmaceutical Corporation - EIR, 2003-06-02
May, 2012 FDA 483 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd - Form 483, 2012-05-17
July, 2006 FDA 483 Generic Sal Inc. - Form 483, 2006-07-17
August, 2001 FDA 483 Response Axiom Pharmaceutical Corporation - Form 483R, 2001-08-14
December, 2007 FDA 483 JP Packaging LLC - Form 483, 2007-12-12
November, 2022 FDA 483 Pharmaceutics International, Inc. - Form 483, 2022-11-14
April, 2015 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2015-04-17
December, 2001 EIR Corwood Labs Inc - EIR, 2001-12-04
July, 2010 FDA 483 Aventis Pharma Manufacturing Pte. Ltd. - Form 483, 2010-07-15
November, 2017 FDA 483 Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Form 483, 2017-11-02
August, 2002 FDA 483 Silarx Pharmaceutical, Inc. - Form 483, 2002-08-08
December, 2008 FDA 483 Patheon UK Limited - Form 483, 2008-12-09
March, 2009 FDA 483 Aspen Notre Dame de Bondeville - Form 483, 2009-03-17
November, 2022 EIR Pharmaceutics International, Inc. - EIR, 2022-11-14
September, 2003 EIR Professional Disposables International, Inc. - EIR, 2003-09-29
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
March, 2002 FDA 483 Axiom Pharmaceutical Corporation - Form 483, 2002-03-15
August, 2006 FDA 483 Strides Pharma, Inc - Form 483, 2006-08-11
March, 2019 FDA 483 ARx, LLC - Form 483, 2019-03-29
November, 2015 FDA 483 Novo Nordisk A/S - Form 483, 2015-11-06
March, 2000 FDA 483 Response Strides Pharma, Inc - Form 483R, 2000-04-07
July, 2008 FDA 483 Geritrex, LLC - Form 483, 2008-07-11
May, 2018 EIR Baxter Pharmaceutical Solutions LLC - EIR, 2018-05-23
August, 2019 FDA 483 NorthStar Medical Radioisotopes, LLC - Form 483, 2019-08-14
May, 2001 FDA 483 Response Fresenius Kabi USA, LLC - Form 483R, 2001-06-18
September, 2008 FDA 483 Silarx Pharmaceutical, Inc. - Form 483, 2008-09-11
March, 2002 FDA 483 Response Axiom Pharmaceutical Corporation - Form 483R, 2002-04-16
September, 2012 FDA 483 Granules India Limited - Form 483, 2012-09-13
October, 2000 EIR Epic Pharma, LLC - EIR, 2000-10-03
December, 2006 FDA 483 Professional Disposables International, Inc. - Form 483, 2006-12-18
June, 2003 FDA 483 Response Axiom Pharmaceutical Corporation - Form 483R, 2003-09-16
July, 2012 FDA 483 Instituto Grifols, S.A. - Form 483, 2012-07-11
January, 2002 EIR Wyeth Pharmaceutical Division of Wyeth Holdings LLC - EIR, 2002-01-24
February, 2007 FDA 483 Barr Laboratories Inc. - Form 483, 2007-02-16
June, 2000 FDA 483 Response Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483R, 2000-06-30
May, 2016 FDA 483 Vericel Corporation - Form 483, 2016-05-27
January, 2007 FDA 483 SML Acquisition, LLC (aka San-mar Laboratories, Inc) - Form 483, 2007-01-19
May, 2008 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2008-05-15
July, 2015 FDA 483 Baxter Healthcare Corporation - Form 483, 2015-07-07
January, 2018 FDA 483 StemGenex Biologic Laboratories, LLC - Form 483, 2018-01-26
May, 2006 EIR Auxilium Pharmaceuticals, LLC - EIR, 2006-05-18
November, 2022 FDA 483 Pharmaceutics International, Inc. - Form 483, 2022-11-14
June, 2016 FDA 483 Protein Sciences Corporation - Form 483, 2016-06-15
March, 2005 FDA 483 Professional Disposables International, Inc. - Form 483, 2005-03-03
May, 2013 FDA 483 Patheon Inc. - Form 483, 2013-05-24
December, 2002 EIR Strides Pharma, Inc - EIR, 2002-12-10
June, 2014 FDA 483 NAMSA - Form 483, 2014-06-11
May, 2018 FDA 483 Baxter Pharmaceutical Solutions LLC - Form 483, 2018-05-23
December, 2011 FDA 483 Labomar Canada Inc - Form 483, 2011-12-02
August, 2005 FDA 483 Barr Laboratories Inc. - Form 483, 2005-08-25
June, 2010 FDA 483 Klinge Chemicals Ltd - Form 483, 2010-06-03
December, 2008 FDA 483 Response Patheon UK Limited - Form 483R, 2008-12-18
December, 2002 FDA 483 Response Strides Pharma, Inc - Form 483R, 2003-01-06
August, 2019 FDA 483 University of Missouri System - Form 483, 2019-08-15
March, 2008 EIR Barr Laboratories Inc. - EIR, 2008-03-05
June, 2006 FDA 483 Silarx Pharmaceutical, Inc. - Form 483, 2006-06-12
June, 2000 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2000-06-23
September, 2002 EIR Professional Disposables International, Inc. - EIR, 2002-09-20
February, 2006 FDA 483 Geritrex, LLC - Form 483, 2006-02-07
July, 2003 EIR Barr Laboratories Inc. - EIR, 2003-07-29
August, 2001 EIR Axiom Pharmaceutical Corporation - EIR, 2001-08-03
June, 2003 FDA 483 Axiom Pharmaceutical Corporation - Form 483, 2003-06-02
February, 2018 EIR Barr Laboratories Inc. - EIR, 2018-02-28
March, 2002 EIR Axiom Pharmaceutical Corporation - EIR, 2002-03-15
January, 2002 FDA 483 Response Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483R, 2002-02-25
January, 2002 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2002-01-24
July, 2003 FDA 483 Barr Laboratories Inc. - Form 483, 2003-07-29
June, 2003 EIR Axiom Pharmaceutical Corporation - EIR, 2003-06-10
January, 2017 FDA 483 UCB Pharma S.A. - Form 483, 2017-01-27
December, 2010 EIR Sicor Societa' Italiana Corticosteroidi s.r.l - EIR, 2010-12-16
June, 2018 FDA 483 Seqirus Inc - Form 483, 2018-06-18
January, 2015 FDA 483 National Genetics Institute - Form 483, 2015-01-15
November, 2018 FDA 483 Pharmaceutics International, Inc. - Form 483, 2018-11-09
August, 2019 FDA 483 Response NorthStar Medical Radioisotopes, LLC - Form 483R, 2019-09-05
December, 2002 FDA 483 Strides Pharma, Inc - Form 483, 2002-12-10
March, 2000 FDA 483 Strides Pharma, Inc - Form 483, 2000-03-23
March, 2006 FDA 483 Novartis Pharmaceuticals Corp. - Form 483, 2006-03-03
December, 2008 EIR Patheon UK Limited - EIR, 2009-04-03
March, 2006 EIR Novartis Pharmaceuticals Corp. - EIR, 2006-03-03
January, 2008 EIR Auxilium Pharmaceuticals, LLC - EIR, 2008-01-23
February, 2018 FDA 483 Barr Laboratories Inc. - Form 483, 2018-02-28
June, 2001 EIR Barr Laboratories Inc. - EIR, 2001-06-29
April, 2005 EIR Auxilium Pharmaceuticals, LLC - EIR, 2005-04-08
June, 2017 FDA 483 Allermed Laboratories, Inc. - Form 483, 2017-06-14
January, 2020 EIR Hospira, Inc. - EIR, 2020-01-17
December, 2000 EIR Wyeth Pharmaceutical Division of Wyeth Holdings LLC - EIR, 2000-12-15
April, 2017 FDA 483 Protein Sciences Corporation - Form 483, 2017-04-13
March, 2000 EIR Strides Pharma, Inc - EIR, 2000-03-23
September, 2012 FDA 483 Ajanta Pharma Limited - Form 483, 2012-09-06
October, 2007 EIR Barr Laboratories Inc. - EIR, 2007-10-19
November, 2022 EIR Pharmaceutics International, Inc. - EIR, 2022-11-14
October, 2014 FDA 483 Fibrocell Technologies, Inc. - Form 483, 2014-10-31
January, 2020 FDA 483 Hospira, Inc. - Form 483, 2020-01-17
November, 2018 EIR Pharmaceutics International, Inc. - EIR, 2018-11-09
November, 2003 EIR Barr Laboratories Inc. - EIR, 2003-11-20
August, 2005 EIR Barr Laboratories Inc. - EIR, 2005-08-25
October, 2013 FDA 483 Daito Pharmaceutical Co., Ltd - Form 483, 2013-10-10
July, 2014 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2014-07-23
July, 2014 EIR Wyeth Pharmaceutical Division of Wyeth Holdings LLC - EIR, 2014-07-23
May, 2010 FDA 483 Taro Pharmaceutical Industries Ltd. - Form 483, 2010-05-28
August, 2001 FDA 483 Axiom Pharmaceutical Corporation - Form 483, 2001-08-03
January, 2017 EIR UCB Pharma S.A. - EIR, 2017-01-27
May, 2012 EIR Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd - EIR, 2012-05-17
November, 2017 EIR AGC Biologics A/S - EIR, 2017-11-07

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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