FDA Investigator Simone E Pitts

Simone E Pitts has conducted inspections on 248 sites in 23 countries as of 30 Oct 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
248
Last Inspection Date:
30 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Germany, India, France, Ireland, United States of America, Japan, Canada, Argentina, Poland, United Kingdom of Great Britain and Northern Ireland, China, Spain, Australia, Belgium, Hong Kong, Switzerland, Italy, Mexico, Denmark, Sweden, Singapore, Netherlands, Israel
FDA Investigators that have inspected at least one site in common with Simone E Pitts:
Abdur Razzaque, Adaliz Santaliz Cruz, Ademola O Daramola, Aditi S Thakur, Aikaterini Alexaki, Alan L Brend, Alan L Truong, 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 Wyan Mai, Ana P Pineda Zavaleta, Ana S Cabrera, Anastasia I Offordile, Anastasia M Shields, Anders W Evenson, Andrew A Hoopes, Andrew A Leboeuf, Andrew C 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 I Rogolsky, Barbara J Rincon, Barbara Janine Breithaupt, Barbara M Frazier, Barbara T Carmichael, Benjamin J Smith, Benton M Ketron, Betsy C Galliher, Bharat Khurana, 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 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 E Lovrich, 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 Nwakijra, 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, Dale A Nyberg, Damaris Y Hernandez, Dana A Razzano, Dandan Wang, PhD, Daniel J Lahar, Daniel J Roberts, Daniel L Obrzut, 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 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, 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, Devon O Seymour, Deyaa Shaheen, Diane C Thibodeau, Diane L Raccasi, Dianiris C Ayala, Dien N Nguyen, Dipesh K Shah, Dolores Harper, Donald C Obenhuber, PhD, Donald G Gordon, Donald L Myers, Dongping Dai, PhD, Donna Mwilliams Hill, PhD, 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, Dr. Zhihao Qiu (Peter), PhD, 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 L Dong, BS, Eric M Mueller, PharmD, Eric M Padgett, Eric S Pittman, Erica B Raphael, Erika E Englund, PhD, Erika V Butler, Erin L Nagel, Evan Tong, Evelyn Taha, Fabian Nchaparro Rodriguez, Farhana Khan, Fatima Bassa, Felix Maldonado, Francis A Guidry, Frank J Marciniak, Frank Verni, Freddy Ortiz Colon, Frederick F 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, Gerard D Difiore, Gerardo Z Vazquez, German Rivera, Gifford Whitehurst, Jr, Ginger M Sykes, Gloria E Parra, Grace I Cortesini, Gregory R Dill, Gregson A Joseph, Guerlain Ulysse, Guo Q Shen, Gwyn G Dickinson, Hala L Selby, Hamet M Toure, PharmD MPH, Harry J Brewer, Haruhiko Murata, Hasan A Irier, PhD, Hector A Carrero, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Helen Y Saccone, Heriberto Negron Rivera, Holly M Scott, Huiquan Wu, Ifueko Osemwota, Iram R Hassan, PhD, Irina Gaberman, Israel Santiago, OCM, Ivis L Negron, J David Doleski, 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 C 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, Jianyang Wang, Jie He, Jin Gao, Joan A Loreng, Joan Adamo, Joanne E King, Joanne M Hajoway, Joanne M Schlossin, Joanne Pryzbylik, Joel D Hustedt, Joey V Quitania, 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, Jonathan G Gayechuway, Jonathan G Matrisciano, Jonathan W Chapman, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, 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, Joshua J Silvestri, 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 H Williams, Kenneth M Gordon, Kenneth Nieves, Kerun Hardeo, Kevin A Gonzalez, Kevin D Kallander, Kevin J Matthews, 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 Edi Gennaro, 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 M Bellows, Lisa M Feola, Lorelei S Jarrell, Loretta Nemchik, 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 I Rosas Marty, Lynda L Perry, PhD, 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 Negron, Maryna C Eichelberger, PhD, Massoud Motamed, Mate Tolnay, 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 Noonan, 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 Curbarg, Michael E Maselli, Michael F Skelly, PhD, Michael Gurbarg, Michael J Vardon, Michael L Casner, Michael Levin, 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 L Jones, Michelle M Noe Varga, Michelle Rfrazier Jessen, PhD, Miguel A Martinez Perez, 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, Nisha C Patel, Noreen Muñiz, Norman K Starks, Norman Wong, Olumide A Martins, 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 E Stein, Paul L Bellamy, Paul Lihong Yeh, PhD, 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, 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 L Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard T Riggie, 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 O'brian, Robert W Fisher, Roberta W Cunningham, Robin Levis, PhD, Rochelle K Kimmel, Rochelle L Cross, Rodney G Raiford, Roger F Zabinski, Roman T Drews, PhD, Ronit Jolles Mazor, Rory K Geyer, Rosa J Motta, Rose Ashley, Rose Xu, Ross J Grigsby, Roy Baby, Roy R Rinc, Rumany C Penn, PharmD, Rupa Pradhan, Russell J Glapion, Russell K Riley, 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, Saundrea A Munroe, Scott A Golladay, Scott B Laufenberg, Scott E Norris, Scott T Ballard, Sergey S Akimov, Shafiq S Ahadi, Shannon A Gregory, Shari L Kahn, Sharmila Shrestha, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Shelby N Turner, Shelina Parvin, 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, Sixto M Mercado Rios, Sneha S Patel, Sonia R Peterson, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey S Degarmo, 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 T Hadman, Susan Yu, Susanna E Ford, Suwaskie S Smith, 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, Tekalign Wondimu, Teresita C Mercado, Terri L Dodds, Terrig Thomas, PhD, Thai D Truong, Thao T Kwan, That Q Dang, Theresa Kirkham (NMI), Thomas E Friel, Thomas J Arista, Thomas J Mooney, Thomas R Withers, Thomas Siebertz, 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, Travis S Bradley, Tricia S Martinez, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Valentino Fiorella, Valerie Jgrecek 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, Xiuju Lu, Yasamin Ameri, Yiping Jia, Yiwei Li, Yonggang Wang, PhD, Yumi J Hiramine, Yuyan Liang, Yvesna C Blaise, Yvette I Johnson, Yvins Dezan, Yvonne C Wilkes, Zachary A Bogorad, Ze Peng, Zhenzhen Liu, PhD, Zhongren Wu, Zi Qiang Gu, Zonglin Hu, Zuben E Sauna, PhD

Simone E Pitts's Documents

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

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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