FDA Investigator Michael A Charles

Michael A Charles has inspections in 33 countries as of 07 Nov 2023. Michael A Charles has collaborated with a combinined 13920 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
433
Last Inspection Date:
07 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Singapore, China, Canada, India, United Kingdom of Great Britain and Northern Ireland, Belgium, Spain, Israel, Malaysia, Switzerland, Taiwan, Turkey, Japan, Norway, France, Colombia, Korea (Republic of), Mexico, Australia, Germany, Italy, Macao, Netherlands, Viet Nam, Egypt, Ireland, Oman, Poland, Dominican Republic, Philippines, Brazil
Co-Investigator(s):
A Williams, Aaron L Dunbar, Adaliz Santaliz Cruz, Ademola O Daramola, Adetutu M Gidado, Aimee Cunningham, PhD, Alan A Rivera, Alan P Kurtzberg, Alanna Lmussawwir Bias, Alberto A Viciedo, Aldo J Milone, Alice S Tsao, Alicia M Mozzachio, Althea A Williams, Amal M Mansour, Amir Alavi, Amy Kim, Anastasia M Shields, Andrea A Branche, Andrea Franco, Andrea George, PhD, Andrea S Heise, Andrew J Garufi, Angela E Glenn, Anita Narula, PhD, Ann B Okon, Ann L Demarco, Ann Marie Montemurro, Anna Lazar, Anthony A Charity, Anthony J Lagreca, Anthony M Criscuolo, Jr, Arduino Frankovic, Arie C Menachem, Ariel Cruz Figueroa, Arlene M Badillo, Arsen Karapetyan, Arthur G Hurst, Arthur S Williams, Jr, Arthur T Ogdahl, Ashar P Parikh, Ashleigh P Barkans, Ashleigh P Wodushek, Ashley N Queen, PhD, Atul J Agrawal, Azza Talaat, Barbara A Gullick, Barbara I Rogolsky, Barbara J Rincon, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Barbara L Rogolsky, Benjamin J Dastoli, Bernice F Hirsch, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Brandy N Lepage, Brenda A Kraengel, Brenda W Uratani, PhD, Brent W Higgs, Brian D Nicholson, Brian J Ryan, Brian P Putz, Brian R Yaun, Bruce G Cooper, Bruce H Mccullough, Bryan A Galvez, Bryce A Hammer, Calvin B Koerner, Candido Torres, Carl A Huffman, III, Carl Lee, Carla A Norris, Carla J Lundi, Carla Lankford, MD, PhD, Carlos Chavez, Caroline H Le, Carolyn J Cook, Cary Greene, Caryn M Mcnab, Cassandra L Abellard, Cassandra L Winters, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Chani Broner, PhD, Charanjeet Jassal, Charisse K Green, Charles D Brown, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheryl A Clausen, Cheryl L Manney, Chikako Torigoe, PhD, Chris A Sack, Christian D Lynch (CDL), Christian Parra, Christina A Miller, Christina Capacci Daniel, PhD, Christina L Bigham, Christine I Shaw, Christine M Rivera, Christine W Twohy, Christopher Downey, PhD, Christopher M Jenner, Christopher R Czajka, Christopher S Fields, Christopher S Keating, Christopher T Middendorf, Christopher T Peters, Claire M Minden, Clinton J Lott, Colleen Thomas, PhD, Concepcion Cruz, Jr, Conception Cruz, Corey A Najuch, Courtney N Long, Craig D Zagata, Crystal A Branch, Ct Viswanathan, PhD, Cynthia A Stempniak, Cynthia J Lee, MS, Cynthia Jim, CSO, Dana A Razzano, Dandan Wang, PhD, Daniel J Roberts, Daniel L Aisen, Danna E Solorzano, Darla J Christopher, Darren S Brown, Dave M Deroche, David A Carlson, David A Oluwo, David A Trent Carlson, David Frucht, MD, David J Gomes, David M Beltran, David M Mcnew, David R Delucia, Dean R Rugnetta, Deborah A Greco, Deborah J Parris, Debra I Love, Debra J Bennett, Demitria J Xiradakis, Denise L Terzian, Denise M Digiulio, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Devaugh Edwards, Devaughn Edwards, Diamond M Oden, Diana K Krepel, Diane L Raccasi, Diane R Weidley, Dipesh K Shah, Djamila Harouaka, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Donald G Gordon, Donald J Ullstrom, Dongping Dai, PhD, Douglas A Campbell, Douglas C Kovacs, Douglas G Ng, Dov Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Gopa Biswas, PhD, Dr. Guang Gao, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. S Nar Ali, PhD, Dustin M James, Edecia A Richards, Edith M Gonzalez, Edmund F Mrak, Jr, Edward D Mcdonald, Eileen A Liu, Eliezar Ramos, Elizabeth A Laudig, Elizabeth D Connell, Elizabeth H Davis, Elizabeth H Slazak, Elizabeth P Kinsella, Ellen P Madigan, Emilie E Kahn, Emmanuel A Dimaano, Jr, Eric J Reisenauer, Eric L Dong, BS, Erica B Raphael, Erika E Englund, PhD, Erika V Butler, Erin L Nagel, Esther B Gamallo Herrera, Esther C Broner, PhD, Evelyn Taha, Farhana Khan, Felix Maldonado, Francis A Guidry, Francis J Eng, Frank L Cordova, Frank Verni, Frederick L Fricke, Gam S Zamil, Gary J Lehr, Gary L Pierce, Gary T Greco, Gavin T Cua, Gayle S Lawson, Genoula K Ryan, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Geraldine D Sanders, Geraldine Sanders, Gerard T Schneider, Ginger M Sykes, Gloria E Parra, Grace E Mcnally, Grace E Menally, Grant L Davis, Gray, Gregson A Joseph, Guerlain Ulysse, Gunneet Kaur, Gwyn G Dickinson, Haitao Li, Hala L Selby, Haroon Vohra (NMI), Harperd, Harry J Brewer, Helen B Ricalde, Helen Verdel, Hilary K Wagner, Huascar Batista, Iraida Ortiz, Iram R Hassan, PhD, Isabel Y Espinosa, Ivis L Negron, Ivis Lnegron Torres, Jacek Cieslak, PhD, Jackson Y See, Jacqueline Mdiaz Albertini, Jacqueline S Warner, Jai P Singh, James A Liubicich, James C Dunnie, Jr, James C Maclaughlin, James D Bridges, James I Giefer, James L Dunnie, Jr, James P Mcreavey, James R Birkenstamm, James R Montero, Jamie L Dion, Jamie M Du, Jana J Lau, Jane Chen, Janet Pulver, Jasmine N Thompson, Jason K Morgan, Javier O Vega, Jawaid Hamid, Jay T Wong, Jazmine N Brown, Jeanette L Mcginnis, Jeanne Fringer, PhD, Jeffery A Hangartner, Jeffrey A Sincek, Jeffrey A Sommers, Jeffrey P Raimondi, Jennifer C Adams, Jennifer J Edmiston, Jennifer J Stone, Jennifer L Huntington, Jennifer L Wolfe, Jennifer Lalama, Jennifer M Gogley, Jerri Baker, Jessica L Pressley, Jianming Li, Jiao Yang, PhD, Joan A Loreng, Joanne E King, Joanne M Schlossin, Jocelyn E Massey, Joel D Hustedt, Joel R Merriman, Joey V Quitania, Jogy George, John A Gonzalez, John A Podsadowski, John D White, Johnna L Bleem, Jonah S Ufferfilge, Jorge L Gonzalez, Jorge L Guadalupe, Jorge L Lajara, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose E Melendez, DDC, Jose M Cayuela, Jose O Hernandez, Jose Ohernandez Guzman, Jose R Hernandez, Jose R Lopez, Jose Velez, Joseph A Dinardo, Joseph A Famiglietti, Joseph Duca, Joseph J Vannelli, Joseph Maselli, Joseph Milcetic, Joshua J Silvestri, Joshua P Wireman, Joy P Matthias, Joyce A Williams, Juan Rjimenez Garcia, Juanita P Versace, Judy Keihl, Julianne C Mccullough, Julie Scoma, June P Page, Junho Pak, Justin A Boyd, Justin R Carr, Kalavati Suvarna, PhD, Kara D Dobbin, Karen A Morgante, Karen A Wolnik, Karen G Hirshfield, Karen K Morsnes, Karen L Kosar, Karen Takahashi, Karla J Gibler, Karlton T Watson, Karyn M Campbell, Katherine D Adams, Katherine E Jacobitz, Katherine Szestypalow, Kellia N Hicks, Kelvin Cheung, Kenneth G Klobus, Kenneth H Williams, Kenneth M Gordon, Kenneth V Miller, Kent C Faul, Kevin A Gonzalez, Kevin D Kallander, Kevin K Cole, Kevin P Foley, Kham Phommachanh, Kim M Downing, Kimberley A Hoefen, Kimberley A Ricketts, Kimberly Y Smithson, Kristy A Zielny, Kumar G Janoria, Kwong P Lee, Kyle J Spencer, Lakshmi Narasimhan, PhD, Lane V Christensen, PhD, Larry K Austin, Larry K Hampton, Lata C Mathew, PhD, Latorie S Jones, Laura Fontan, MS, Lauren E Blaser, Laurie B Frazier, Laurie Nelson, Laurimer Kuilan Torres, Lawrence J Stringer, Lawrence W Farina, LCDR Chad N Thompson, Leonard H Lavi, Libia M Lugo, Lillian S Wu, Liming Zhang, Linda F Murphy, Linda K Cline, Linda L Ng, Linda M Cheny, Linda M Pyjas, Linda M Sacco, Linda Thai, Lori A Carr, Lori B Wikstrom, Lori J Silverstein, Lorraine L Chavis, Louis G An, LT Rafael Gonzalez, LTJG Matthew R Palo, Lucas B Leake, Luella J Rossi, Luis A Dasta, Luis M Burgos, Luis M Burgos Medero, Lydia Irosas Marty, Madushini Dharmasena, PhD, Manhar R Patel, Maotang Zhou, PhD, Marc S Neubauer, Marcellinus D Dordunoo, Marcus F Yambot, Mare S Neubauer, Margaret E Sarles, Margaret L Bolte, Margaret M Annes, Maria A Reed, Maria Gutierrez Lugo, PhD, Marian E Ramirez, Marianela Aponte Cruz, Marie Bbuen Bigornia, Marie Elena C Puleo, Marie F Morin, Marijo B Kambere, PhD, Marion Michaelia, Marion Michaelis, Marion W Nadeau, Mariza M Jafary, Mark C Saale, Mark E Parmon, Mark R Mcclain, Marlene G Swider, Marlene L Davis, Mary E Farbman, PhD, Mary E Storch, Mary M Finn, Maryam Tabatabaie, Massoud Motamed, Matthew A Spataro, Matthew B Casale, Matthew D Schnittker, Matthew J Hansen, Matthew M Henciak, Matthew R Dionne, Maureen A Wentzel, Maxwell Van Tassell, PhD, Maxyne T Lam, Megan A Haggerty, Meisha R Sampson, Meisha Waters, Melissa A Henaghan, Melissa D Ray, Melissa F Chauvin, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Meredith P Soehl, Investigator, Meyer J Slobotsky, Michael A Taylor, Michael D Smedley, Michael E Maselli, Michael G Sinkevich, Michael J Kuchta, Michael Kuchta, Michael L Chasey, Michael Levin, Michael P Sheehan, Michael P Sweeney, Michael R Dominick, Michael R Goga, Michael S Araneta, Michael S Smoker, Michael Shanks, MS, Michael T Cyrus, Michael W Burd, Michele Dougherty, PhD, Michele Gottshall, Michele L Obert, Michele Perry Williams, Michelle D Haamid, Michelle L Dragon Nagel, Michelle Y Clark Stuart, Miguel A Martinez, Mihaly S Ligmond, Milva E Melendez, Milva Emelendez Perales, Mindy M Chou, Minh D Phan, Monica Commerford, PhD, Monica J Wilkins, Monica M Mcclure, Morris Paul, Mra B Kamberem, Mra Davism, Mra Greenc, Mra Mcculloughj, Mra Narulaa, Muralidhara B Gavini, PhD, Myriam M Sosa, Nadeem I Chaudhry, Nancy A Saxenian, Nancy A Saxenian Emmons, Nancy G Schmidt, Nancy L Rolli, Natalie A Mickelsen, DVM, Nathan M Jornod, Nathan R Moon, Nayan J Patel, Nazmul Hassan, Neal L Adams, Nealie C Newberger, Neil J Bonzagni, PhD MPH, Neira Acevedo Ramos, Nerizza B Guerin, Nicholas A Violand, Nicholas C Mendiola, Nicholas L Hunt, Nicholas Obiri, PhD, Nicole E Knowlton, Niketa Patel, Nikolay Spiridonov, Noreen Muniz, Noreen Muñiz, Norman K Starks, Normica G Facey, Nydia E Colon, Omotunde O Osunsanmi, Otto D Vitillo, Pankaj H Amin, Paraluman S Leonin, Parul M Patel, Patrice S Hall, Patricia A Brown, Patricia A Clark, Patricia A Cortez, Patricia Brown, Patricia Fhughes Troost, Patricia G Leinbach, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick L Wisor, Patty P Kaewussdangkul, Paul A Bonneau, Paul E Stein, Paul J Teitell, Paul L Bellamy, Paul Lihong Yeh, PhD, Paul M Kawamoto, Paul Mouris, Paul Z Balcer, Paula A Trost, Paula M Laplant, Pei I Chu, Peng Zhou, Perez, Perry T Nichols, Peter Abel, Peter E Baker, Peter M Trunk, Peter R Caparelli, Philip F Istafanos, DMV, MS, Phyllis J Wilson, Prabhu P Raju, Pratik S Upadhyay, DDC, Qin Xu, Rachael A Moliver, Rachel C Harrington, Rafael Nevarez Nieves, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramesh Potla, PhD, Ramon A Hernandez, Ramon E Martinez, Randi Lynn Bodoh, Raquel Gonzalez Rivera, Raymond D Kent, Raymond T Oji, Reba A Gates, Rebecca E Dombrowski, Rebecca H Lee, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Rene R Ramirez, Reyes Candau Chacon, PhD, Richard E Needham, Richard J Friedman, Richard Jay Tucker, RS, Richard K Glabach, Richard L Friedman, Richard L Rutherford, Richard Ledwidge (nmi), PhD, Richard W Thornton, Ricki A Chase, Riley C Myers, PhD, Rita K Kabaso, Rober C Horan, PhD, Robert C Howard, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Doyle, Robert J Ham, Robert J Martin, Robert J Veitch, Robert Sharpnack, Rochelle K Kimmel, Rodney G Raiford, Roger F Zabinski, Roger L Farmer, Ronald Ifraimov, Rory K Geyer, Rose M Ashley, Rowena S Nguyen, Rozelle G Smith, Ruben C Ayala, PharmD, Russ E Davis, Russell J Glapion, Russell K Riley, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Samantha J Bradley, Samanthan J Bradley, Samina S Khan, Samir C Gala, Samuel T Walker, Sandra A Boyd, Sandra A Hughes, Sandra I Gaul, Sangeeta M Khurana, PhD, Sanket N Patel, Santiago Gallardo Johnson, Santos E Camara, Sarah A Meehan, Sarah E Mcmullen, Sargum C Sood, Sasha M Latonis, Satheesh Thomas, Saundrea A Munroe, Scott B Laufenberg, Scott R Nichols, PhD, Scott T Ballard, Sean R Marcsisin, Seneca D Toms, Shannon A Dinardo, Shantelle I Hughes, Shari L Kahn, Sharon K Thoma, PharmD, Shawn E Larson, Shelby N Marler, Shererk, Sherry G Bous, Shirshendu K Deb, PhD, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sneha S Patel, Sonia R Peterson, Sony Mathews, Sonya L Karsik, Stacie A Woods, State Agency, Stephanie A Slater, MS, Stephanie T Durso, Stephen D Brown, Stephen D Eich, Stephen J Koniers, Stephen J Mottola, Stephen T Hansen, Steve Y Rhieu, PhD, Steven C Madzo, Steven C Nattrass, Steven D Dittert, Steven D Kehoe, Steven E Kane, Steven Fong, MS, PhD, Steven J Libal, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan M Joseph, Susan P Bruederle, Susan W Ting, Susanna E Ford, Analyst, Susanne M Richardson, MSc RAC ELS, Susant Hadman, Syed N Ali, Tajah L Blackburn, Tamara M Kays, Tamil Arasu, PhD, Tammy S Notto, Tanya R Syffrard, Tara L Breckenridge, Tara L Greene, Ted L Anderson, Teena H Aiken, Temar Q Williams, Tenzin Jangchup, Teresa I Navas, Teresa Jimenez, Terri L Dodds, Terry Bridgewater, Thai T Duong, Thanh M Andrews, Theresa Kirkham (NMI), Theressa B Smith, Thomas A Peter, Thomas E Friel, Thomas J Arista, Thomas J Dinunzio, Thomas J Mooney, Thomas L Bellonte, Thomas P Hansen, Thomas S Arista, Thomas S Savage, Thuy T Nguyen, LCDR, Tiara M Brown, Timothy T Kapsala, Timothy Wadkin, PhD, Tina M Pawlowski, Todd M Stankewicz, Tomika L Bivens, Tonia F Bernard, Tonya R Johnson, Torrance J Slayton, Tracey L Harris, Tracy M Portelli, Travis R Hunt, Truong Xuan Nguyen (Andy), Tsedenia Woldehanna, Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie A Potopsingh, Vani Mathur Richards, Verlinda A Narcisse, Vicky L Cruz, Vilmary Negron Rodriguez, Virginia Carroll, PhD, Virginia L Sheldon, Viviana Matta, Vivin George, Vlada Matusovsky, Walden H Lee, Wayne D Mcgrath, Wayne E Seifert, Wen Ning Chan (Sally), Wendy G Tan, PhD, Wendy M Stone, William C Lubas, William J Leonard, William M Rennells, William P Chilton, Xianghong Jing (Emily), PhD, Xiaohan Cai, PhD, Xiaohui Shen, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Xiomara Copeland, Yasamin Ameri, Ying Xin Fan, PhD, Yiyue Zhang (nmi), PhD, Youkeun Kim, Yumi J Hiramine, Yuyan Liang, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhaoyang Meng, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu

Michael A Charles's Documents

Publish Date Document Type Title
January, 2021 FDA 483 Infinity Laboratories, LLC - Form 483, 2021-01-07
August, 2010 FDA 483 Teva Pharmaceutical Industries Ltd. - Form 483, 2010-08-26
March, 2019 FDA 483 Laboratorios Farmalan, S.A. - Form 483, 2019-03-19
July, 2019 FDA 483 Dexcel Pharma Technologies - Yokneam Factory - Form 483, 2019-07-17
July, 2017 FDA 483 Response DOTTIKON EXCLUSIVE SYNTHESIS AG - Form 483R, 2017-08-04
January, 2014 EIR TOLMAR Inc. - EIR, 2014-01-31
October, 2018 FDA 483 Savior Lifetec Corporation Tainan Branch - Form 483, 2018-10-26
February, 2020 FDA 483 TOLMAR 1201 Cornerstone LLC - Form 483, 2020-02-24
February, 2010 FDA 483 Wavelength Enterprises LTD - Form 483, 2010-02-04
November, 2016 FDA 483 Suzhou Amerigen Pharmaceutical Co., Ltd. - Form 483, 2016-11-11
June, 2010 FDA 483 Glaxo Wellcome S.A. - Form 483, 2010-06-24
January, 2016 FDA 483 Cadila Pharmaceuticals Limited - Form 483, 2016-01-29
January, 2023 FDA 483 CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED - Form 483, 2023-01-18
January, 2014 FDA 483 Response TOLMAR Inc. - Form 483R, 2014-02-24
May, 2010 FDA 483 ACS DOBFAR SPA - Form 483, 2010-05-13
September, 2010 FDA 483 NORTON (WATERFORD) LIMITED - Form 483, 2010-09-02
January, 2021 EIR Infinity Laboratories, LLC - EIR, 2021-01-07
November, 2022 FDA 483 Pharmaplast SAE - Form 483, 2022-11-10
July, 2019 FDA 483 Bio-Technology General (Israel) Ltd. - Form 483, 2019-07-11
June, 2015 FDA 483 TOLMAR 1413 ACQUISITION, LLC - Form 483, 2015-06-18
January, 2014 FDA 483 TOLMAR Inc. - Form 483, 2014-01-31
September, 2019 FDA 483 Wuxi Fortune Pharmaceutical Co., Ltd - Form 483, 2019-09-06
January, 2004 EIR Bausch & Lomb Incorporated - EIR, 2004-01-08
January, 2018 FDA 483 Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - Form 483, 2018-01-26
March, 2020 FDA 483 Curia New Mexico, LLC - Form 483, 2020-03-20
January, 2016 FDA 483 Zydus Lifesciences Limited - Form 483, 2016-01-22
February, 2010 FDA 483 NEXTPHARMA PLOERMEL - Form 483, 2010-02-17
July, 2017 FDA 483 DOTTIKON EXCLUSIVE SYNTHESIS AG - Form 483, 2017-07-14
September, 2004 EIR American Regent, Inc. - EIR, 2004-09-10
February, 2020 EIR TOLMAR 1201 Cornerstone LLC - EIR, 2020-02-24
May, 2013 FDA 483 Moehs Catalana SL - Form 483, 2013-05-09
September, 2012 FDA 483 Sun Pharmaceutical Industries Limited - Form 483, 2012-09-26
September, 2017 FDA 483 Meda Manufacturing GmbH - Form 483, 2017-09-07
January, 2019 FDA 483 Esteve Huayi Pharmaceutical Co., Ltd. - Form 483, 2019-01-23
January, 2004 FDA 483 Bausch & Lomb Incorporated - Form 483, 2004-01-08
October, 2014 FDA 483 Actavis Laboratories UT, Inc. - Form 483, 2014-10-17
February, 2017 FDA 483 Skin Sciences Laboratory, Inc. - Form 483, 2017-02-01
May, 2012 EIR DIVI'S LABORATORIES LIMITED - EIR, 2012-05-23
September, 2004 FDA 483 American Regent, Inc. - Form 483, 2004-09-10
January, 2013 FDA 483 Japan BCG Laboratory - Form 483, 2013-01-24
March, 2016 FDA 483 Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2016-03-08
May, 2003 FDA 483 Response Fresenius Kabi USA, LLC - Form 483R, 2003-06-19
January, 2023 FDA 483 Rubicon Research Private Limited - Form 483, 2023-01-27
May, 2013 EIR Moehs Catalana SL - EIR, 2013-05-09
June, 2015 EIR TOLMAR 1413 ACQUISITION, LLC - EIR, 2015-06-18
July, 2019 FDA 483 Dexcel Ltd. - Form 483, 2019-07-24
March, 2021 FDA 483 BSO LLC - Form 483, 2021-03-11
August, 2022 FDA 483 F. Hoffmann-La Roche Ltd - Form 483, 2022-08-05
March, 2016 EIR Boehringer Ingelheim Pharma GmbH and Co. KG - EIR, 2016-03-08
May, 2019 FDA 483 Response GLAND PHARMA LIMITED - Form 483R, 2019-06-06
October, 2014 EIR Actavis Laboratories UT, Inc. - EIR, 2014-10-17
September, 2020 FDA 483 STAQ Pharma, Inc. - Form 483, 2020-09-03
September, 2013 FDA 483 CP Pharmaceuticals Ltd - Form 483, 2013-09-10
June, 2008 FDA 483 Tishcon Corp - Form 483, 2008-06-17
July, 2012 FDA 483 Sun Pharma Advanced Research Company Limited - Form 483, 2012-07-31
January, 2017 FDA 483 Dasan E&T Co., Ltd. - Form 483, 2017-01-25
November, 2022 FDA 483 National Pharmaceutical Industries - Form 483, 2022-11-16
December, 2011 FDA 483 CIPLA LIMITED - Form 483, 2011-12-01
June, 2004 EIR Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc. - EIR, 2004-06-15
May, 2019 FDA 483 GLAND PHARMA LIMITED - Form 483, 2019-05-16
December, 2015 FDA 483 Thatcher Company - Form 483, 2015-12-10
March, 2017 FDA 483 MSD International GmbH (Singapore Branch) - Form 483, 2017-03-16
January, 2021 FDA 483 Response Infinity Laboratories, LLC - Form 483R, 2021-01-07
June, 2008 FDA 483 Contract Pharmacal Corp. - Form 483, 2008-06-13
December, 2021 FDA 483 KBI Biopharma, Inc. - Form 483, 2021-12-03
June, 2003 FDA 483 Response American Regent, Inc. - Form 483R, 2003-07-17
January, 2012 EIR Wockhardt Limited - EIR, 2015-05-26
May, 2003 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2003-05-30
January, 2019 FDA 483 Xi'an Livingbond Nonwoven Products Corp., Ltd. - Form 483, 2019-01-10
September, 2022 FDA 483 CIRON DRUGS AND PHARMACEUTICALS PVT LTD - Form 483, 2022-09-21
February, 2015 FDA 483 Rocky Mountain Poison & Drug Center - Form 483, 2015-02-25
March, 2018 FDA 483 Steriscience Specialties Private Limited - Form 483, 2018-03-13
December, 2021 EIR KBI Biopharma, Inc. - EIR, 2021-12-03
September, 2018 FDA 483 ATLAS R&D Inc - Form 483, 2018-09-06
January, 2014 FDA 483 Fresenius Medical Care North America - Form 483, 2014-01-10
November, 2018 FDA 483 ST Pharm Co., Ltd. - Form 483, 2018-11-08
July, 2020 FDA 483 Bayer AG - Form 483, 2020-07-27
August, 2014 FDA 483 Brown's Compounding Center, Inc. - Form 483, 2014-08-11
July, 2005 EIR LNK International, Inc. - EIR, 2005-07-28
July, 2018 FDA 483 UQUIFA Mexico, S.A. de C.V. - Form 483, 2018-07-27
October, 2013 FDA 483 Sandoz Incorporated - Form 483, 2013-10-17
March, 2020 EIR Curia New Mexico, LLC - EIR, 2020-03-20
June, 2004 FDA 483 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, Inc. - Form 483, 2004-06-15
May, 2015 FDA 483 College Pharmacy, Inc. - Form 483, 2015-05-28
November, 2018 FDA 483 Response ST Pharm Co., Ltd. - Form 483R, 2018-11-28
August, 2012 FDA 483 Amneal Pharmaceuticals Private Limited - Form 483, 2012-08-17
January, 2020 FDA 483 KC Pharmaceuticals, Inc. - Form 483, 2020-01-30
May, 2016 FDA 483 MSD International GmbH (Singapore Branch) - Form 483, 2016-05-20
February, 2015 FDA 483 Response Amgen, Inc. - Form 483R, 2015-02-27
August, 2007 EIR YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD. - EIR, 2007-09-10
November, 2011 FDA 483 CIPLA LIMITED - Form 483, 2011-11-08
November, 2019 FDA 483 GLAND PHARMA LIMITED - Form 483, 2019-11-07
July, 2021 FDA 483 TAILSTORM HEALTH INC - Form 483, 2021-07-21
July, 2014 FDA 483 Curia New Mexico, LLC - Form 483, 2014-07-17
January, 2012 EIR Wockhardt Limited - EIR, 2012-01-27
May, 2016 FDA 483 Tien Yuan Chemical (Pte) Ltd - Form 483, 2016-05-13
September, 2003 FDA 483 Tri State Surgical - Form 483, 2003-09-11
July, 2013 EIR Energy Los Alamos Office, United States Department of - EIR, 2013-07-31
December, 2005 FDA 483 Mentholatum Company, The - Form 483, 2005-12-15
August, 2013 FDA 483 Curia New Mexico, LLC - Form 483, 2013-08-23
July, 2020 EIR Bayer AG - EIR, 2020-07-27
June, 2006 FDA 483 Bausch & Lomb Incorporated - Form 483, 2006-06-28
June, 2003 EIR American Regent, Inc. - EIR, 2003-06-30
June, 2003 FDA 483 American Regent, Inc. - Form 483, 2003-06-30
April, 2014 FDA 483 Shionogi Pharma Co., Ltd. - Form 483, 2014-04-01
February, 2015 FDA 483 Amgen, Inc. - Form 483, 2015-02-11
April, 2015 FDA 483 Nang Kuang Pharmaceutical Co. Ltd. - Form 483, 2015-04-24
July, 2003 FDA 483 Par Pharmaceuticals - Form 483, 2003-07-02
February, 2007 FDA 483 ONY Biotech Inc. - Form 483, 2007-02-20
January, 2018 FDA 483 Ningbo Liyuan Daily Chemical Products Co., Ltd - Form 483, 2018-01-11
October, 2013 FDA 483 Wiley Chemists Inc. - Form 483, 2013-10-02
September, 2020 EIR STAQ Pharma, Inc. - EIR, 2020-09-25
September, 2004 FDA 483 Response American Regent, Inc. - Form 483R, 2004-09-16
August, 2015 FDA 483 Alexion Pharmaceuticals, Inc. - Form 483, 2015-08-12
September, 2014 FDA 483 Ultradent Products, Inc. - Form 483, 2014-09-12
December, 2005 EIR Mentholatum Company, The - EIR, 2005-12-15
October, 2021 FDA 483 Denver Solutions, LLC DBA Leiters Health - Form 483, 2021-10-07
February, 2022 FDA 483 L M Manufacturing Limited - Form 483, 2022-02-02
October, 2015 EIR Infinity Laboratories, LLC - EIR, 2015-10-29
December, 2021 FDA 483 Response KBI Biopharma, Inc. - Form 483R, 2021-12-17
September, 2020 FDA 483 Response STAQ Pharma, Inc. - Form 483R, 2020-09-16
July, 2017 FDA 483 Legacy Pharmaceuticals Switzerland GmbH - Form 483, 2017-07-21
February, 2015 EIR Amgen, Incorporated - EIR, 2015-02-11
January, 2018 FDA 483 Zhejiang Charioteer Pharmaceutical Co., Ltd. - Form 483, 2018-01-18
June, 2018 FDA 483 Laboratorios Baxter S A - Form 483, 2018-06-08
September, 2018 FDA 483 Patheon Inc. - Form 483, 2018-09-14
July, 2008 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2008-07-30
January, 2008 EIR SPS Medical Supply Corporation - EIR, 2008-01-04
February, 2009 FDA 483 Shasun Pharmaceuticals Limited. - Form 483, 2009-02-26
February, 2015 EIR Amgen, Inc. - EIR, 2015-02-11
May, 2010 FDA 483 ACS Dobfar SPA - Form 483, 2010-05-10
January, 2011 EIR Shenzhen Hepalink Pharmaceutical Group Co., Ltd. - EIR, 2011-01-27
May, 2011 FDA 483 Apitoria Pharma Private Limited - Form 483, 2011-05-26
September, 2019 FDA 483 Jiangsu Grand Xinyi Pharmaceutical Co., Ltd. - Form 483, 2019-09-12
February, 2015 FDA 483 Amgen, Incorporated - Form 483, 2015-02-11
February, 2015 EIR Rocky Mountain Poison & Drug Center - EIR, 2015-02-25
January, 2012 FDA 483 Wockhardt Limited - Form 483, 2012-01-27
October, 2019 FDA 483 Apitoria Pharma Private Limited - Form 483, 2019-10-28
March, 2015 FDA 483 Hunter Holmes McGuire Veterans Affairs Medical Center Mammography - Form 483, 2015-03-11
October, 2008 EIR ScinoPharm Taiwan, Ltd. - EIR, 2015-06-09
January, 2019 FDA 483 Aino Co., Ltd. of North China Pharmaceutical Group - Form 483, 2019-01-17
September, 2022 FDA 483 Zydus Animal Health and Investments Limited - Form 483, 2022-09-29

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  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

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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