FDA Investigator Bonita S Chester

Bonita S Chester has conducted inspections on 298 sites in 14 countries as of 20 Sep 2021. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
298
Last Inspection Date:
20 Sep 2021
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Japan, Netherlands, India, Germany, Spain, Canada, Italy, China, France, Hungary, United Kingdom of Great Britain and Northern Ireland, Ireland, Slovenia
FDA Investigators that have inspected at least one site in common with Bonita S Chester:
Aaron P Wozniak, Abdollah Koolivand, Abdur Rashid, Adam J Williams, Adam R Cooke, Adetutu M Gidado, Alan P Kurtzberg, Alanna L Mussawwir Bias, Albert A Salvador, Alicia M Mozzachio, Alicia S Gates, Allen F Hall, Althea A Williams, Amanda E Lewin, PhD, Amanda L Evanco, Amy Devlin, PhD, Amy H Ruble, Ana L Kewes, Ana P Barido, Anastasia M Shields, Andrea L Williams Jones, Angela E Glenn, Anh M Lac, Ann B Borromeo, Anna Lazar, Annette Melendez, Anthony A Charity, Anthony J Ladner, Arie C Menachem, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arsen Karapetyan, Arthur T Ogdahl, Ashley P Currier, Ashley P O'neill, Ashutosh Rao, PhD, Azza Talaat, Babatunde D Babalola, Bapu R Gaddam, Barbara Janine Breithaupt, Barbara M Frazier, Barbara T Carmichael, Bei Y He, Benjamin E Bowen, Beth F Fritsch, Betsy C Galliher, Bijoy Panicker, Bill Tacket, Jr, Bo Chi, PhD, Brandon C Heitmeier, Brandy D Brown, Brandy N Lepage, Brenda Rivera, Brentley S Collins, Brett D Weed, Brett Weed, Brian A Graves, Brittny C Cargo, Burnell M Henry, Calvin B Koerner, Camerson E Moore, Carl E Lovrich, Carl Lee, Carla A Norris, Carla J Lundi, Carlos A Ortiz, Carol F Robinson, Carolyn A Renshaw, Carrie A Hughes, Cassandra L Abellard, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Chaoying C Ma, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Charles Yuanchia Kuo, PhD, Charvais S Hill, Chateryl K Washington, Cherrie A Zachary, Cheryl Love Harris, Christian D Lynch (CDL), Christie A Beatty, Christie B Rice, Christina H Owens, Christopher Downey, PhD, Christopher S Keating, Christopher T Smith, Chunsheng Cai, PhD, Claire M Minden, Clara E Santiago, Claudette D Brooks, Clifton L Randell, Clotia Cabbey Mensah, Colleen M Aspinwall, Constance Y Fears, Constantin Y Philopoulos, Cordelia J Brammer, Courtney A Gilbert, Craig A Garmendia, Craig D Zagata, Craig T Rybus, Crystal A Harlan, Cynthia Jim, CSO, D Ross Spears, PhD, Dana M Klimavicz, Daniel L Aisen, Daphne Santiago, PhD, Darren S Brown, David J Gomes, David P King, David R Heiar, David T Glover, David Williams, Dawn C Olenjack, Dawn M Braswell, Deborah A Greco, Debra I Love, Debra J Tucker, Delkis J Caycedo, Dellarese L Herbert, Demario L Walls, Denise M Digiulio, Dennis Cantellops Paite, Derek C Price, Derek S Dealy, Desiree D Clark, Devaughn Edwards, Diane Hall, Diane P Goyette, Dianiris C Ayala, Dipesh K Shah, Doan T Nguyen, PharmD, Donald C Obenhuber, PhD, Doretha M Wilson, Dorothy P Kramer, Douglas A Campbell, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Jason R Caballero, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Zhihao Qiu (Peter), PhD, Edecia A Richards, Edward Deberry, Edward Lukeman, Edwin J Gorney, Edwin Martinez, Edwin Melendez, Eileen A Liu, Eileen J Bannerman, Elena Karnaukhova, PhD, Elizabeth D Connell, Enada F Archibold, Eric M Mueller, PharmD, Eric R Holm, Eric S Weilage, Erika E Englund, PhD, Erika V Butler, Ernest H Blackwood, Esra Toussaint, Ethan P Stegman, Eural E Porter, Fabian Nchaparro Rodriguez, Farhana Khan, Felix Maldonado, Frank W Perrella, Frank Wackes, Fulton A Varner, Gabriel E Muniz, Gabriel R Mclemore, Gajendiran Mahadevan, PhD, Gam S Zamil, Gamal A Norton, Gary E Coleman, Jr, REHS, Gates E Raynor, Gavin T Cua, Gayle S Lawson, Gene D Arcy, George G Calafactor, George J Flynn, Geraldine D Sanders, German Rivera, Gideon N Esuzor, Gilbert T Salud, Ginger M Sykes, Guerlain Ulysse, Guo Q Shen, Gwyn G Dickinson, Hai Lient Phung, Haijing Hu, Harshal J Desai, Hasan A Irier, PhD, Heather M Bullock, Hector A Carrero, Helen B Ricalde, Helen R Bester, Hristu B Chepa, Ibad U Khan, Ingrid A Zambrana, Ivan E Reyes, Ivis L Negron, Ivy E Sweeney, Jacek Cieslak, PhD, Jacqueline D Mitchell, Jacqueline Mdiaz Albertini, James C Maclaughlin, James D Planchon, James L Kenney, DSc, James P Lewis, Jr, James R Birkenstamm, James R Evans, James To Neal, Jamie L Port, Jamirya S Weatherly, Jana L Caylor, Janet B Gray, Janete F Guardia, Jared P Stevens, Jason F Chancey, Jason K Morgan, Javier O Vega, Jawaid Hamid, Jee Chung, PhD, Jeffrey D Sheppard, Jeffrey P Raimondi, Jennifer J Stone, Jennifer L Huntington, Jennifer L Sheehan, Jennifer Lalama, Jennifer M Menendez, Jeremy W Rotton, Jessica Fields, Jessica L Pressley, Jie He, Jimmy O Buford, Joan T Briones, Joann Walters Salvatierra, Joanne E King, Joanne Heim, Joanne T Gabay, Joel D Hustedt, Jogy George, John D Lloyd, John D White, John J Bernal, John S Hartford, Johnetta F Walters, Jolanna A Norton, Jonathan G Matrisciano, Jonathan G Swoboda, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, Jose M Cayuela, Jose R Hernandez, Joseph F Owens, Joseph J Vannelli, Joseph Kutze, PhD, Joshua P Wireman, June P Page, Junho Pak, Justin A Boyd, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Kara D Dobbin, Karen E D'orazio, Karen M Cooper, Kassa Ayalew, MD, Katherine M Taylor, Katherine Szestypalow, Kathleen D Culver, Kathleen M Sinninger, Kathryn A Krentz, Katrina B Mosley Sloan, Keith A Schwartz, Kemejumaka N Opara, Kenneth H Williams, Kenneth L Smalls, Kenny R Robinson, Kevin A Gonzalez, Kevin T Nguyen, Khalid M Khan, Kham Phommachanh, Kim Lthomas Cruse, Kimberley A Hoefen, Kimberly Cdelk Brooks, Kip J Hanks, Kirsten L Vadheim, PhD, Kirtida Patel, Kunapuli T Madhusudhan, Ladner Ladner, Anthony J, Laiza V Garcia, Lakecha N Lewis, Lance Mde Souza, MBA, Lareese K Thomas, Larry K Austin, Larry K Hampton, Lata C Mathew, PhD, Latorie S Jones, Laura E Garcia, Laura I Salazar, PhD, Laurel A Beer, Laurie B Frazier, Laurie Nelson, LCDR Angelica M Chica, LCDR Debra Emerson, LCDR Randall L Morris, Leah M Andrews, Lei Zhang, PhD, Leo J Lagrotte, Leonard H Lavi, Leopold Kong, PhD, Leroy Terrelonge, Lesley K Satterwhite, Leslie Arivera Rosado, PhD, Leslie W Gilbert, Leslie W Jones, Libia M Lugo, Lidia Cdiaz Castaneda, Lillie D Witcher, Liming Zhang, Linda K Matheny, Linda R Kuchenthal, Lisa R Jennings, Lisa R Whitt, Lois K Gross, Lori G Cantin, LT Daveta L Bailey, LT Richard A Lyght, LT Tamara J Henderson, Lucas B Leake, Luella J Rossi, Luis A Dasta, Luis Mburgos Medero, Lura D Baquero, Luz I Collado, Makini Cobourne Duval, PhD, Mancia R Walker, Marc R Dickens, Marcella D Crook, Marcia A Worley, Marcia Gelber, Margaret M Annes, Marie F Mathews, Marie F Morin, Marion Michaelis, Marisa E Stock, Marisol Faberlle, Marla A Cassidy, Marshalette O Edwards, Martin K Yau, PhD, Marvin D Jones, Mary E Farbman, PhD, Mary E Storch, Mary Jeanet Mcgarry, Mary Kaulee, Massoud Motamed, Matthew B Casale, Matthew G Brown, Mcbean, Megan A Haggerty, Megan T Ziegler, Melanie M Walker, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Metitia G Sanders, Metitia M Gramby, Michael A Charles, Michael A Taylor, Michael F Skelly, PhD, Michael L Chasey, Michael P Anthony, Michael R Goga, Michael S Budziak, Michele L Obert, Michele Perry Williams, Michelle D Haamid, Michelle L Jones, Miguel A Martinez Perez, Mihaly S Ligmond, Milva E Melendez Perales, Minh D Phan, Mizanne E Lewis, Mohsen Rajabi Abhari, FDA, Mokhless A Ghaly, Mra Davism, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Myla D Chapman, Myoshi M Francis, Nadeem I Chaudhry, Nakesha J Jackson, Nancy E Fontaine, Narong Chamkasem, PhD, Nayan J Patel, Nerming V Briones, Nicholas L Paulin, Nicholas M Smith, Nicole A Lloyd, Nicole E Knowlton, Nicole K Trudel, Nicole M Bell, Nije A Thomas, Niketa Patel, Nilufer M Tampal, PhD, Noreen Muñiz, Nutan Mytle, Omayra Nrodriguez Ruiz, Omotunde O Osunsanmi, Pankaj H Amin, Parul M Patel, Patrice S Hall, Patricia F Hudson, Patricia F Hughes, PhD, Patrick B Cummings, Patrick D Stone, MS, Patrick L Wisor, Patsy J Domingo, Patty P Kaewussdangkul, Paul A Bonneau, Paul A Licata, Paul H Dakin, Paul W Moy, Paula A Trost, Paula J Bretz, Paula R Katz, Penny H Mccarver, Peter E Baker, Phillip M Pontikos, Postelle Birch Smith, Prabhu P Raju, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qin Xu, R Edwadebey Deberry, Rachael A Moliver, Rachael L Cook, Rachael O Oyewole, Rachel C Harrington, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramon A Hernandez, Randy L Clarida, Rashonda N Rucker, Raymond A Lyn, Jr, Raymond T Oji, Reba A Gates, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard Heath Coats, Richard Lyght, Robert C Coleman, Robert C Steyert, Robert J Ham, Robert J Martin, Robert Jennings, Robert L Lewis, Jr, Robert M Barbosa, Robin N Goins, Rochelle L Cross, Rodney L Tinzie, Roger F Zabinski, Rona Leblanc, PhD, Ronnie E Jackson, Ronsha Y Hill, Rose Ashley, Ruben C Ayala, PharmD, Russell J Glapion, Russell K Riley, Saied A Asbagh, Saleem A Akhtar, Sally Gopaul, Samantha J Bradley, Samantha J Pinizzotto, D V M, Samuel L Murray, Sandra A Boyd, Sandra A Hughes, Sandra I Gaul, Sangeeta M Khurana, PhD, Sanket N Patel, Santos E Camara, Sara Rothman, Sarah Forney, Sarah L Holliday, Saundrea A Munroe, Sayeeda Hdabe, Scott B Laufenberg, Scott T Ballard, Seneca D Toms, Sereen Gmorgan Murray, Sergio E Delgado, Sharna D Pratt, Sharon K Thoma, PharmD, Shavon L Square, Shawn E Larson, Shelby N Turner, Sherbet L Samuels, Sheri S Oliver, Sherri N Rohlf, MD, Shirley Brown, Shirley H Isbill, Shirley J Berryman, Shirley S Brown, Shusheen A Alexander, Sidney B Priesmeyer, Simon Williams, PhD, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sondra L Phillips, Song Y Lavalais, Sonya M Edmonds, Sripal R Mada, PhD, Stacey A Meyer, Stacey F Allard, Stardust W Mazzariello, Stephanie D Crockett, Stephanie E Hubbard, Stephanie Harrell, Stephen D Brown, Stephen J Koniers, Steven C Madzo, Steven D Kehoe, Steven Fong, MS, PhD, Steven J Rush, Steven M Weinman, Susan F Laska, MS, Susan M Jackson, Susan M Turcovski, Susan O Oladeji, Susan T Hadman, Susan W Ting, Susanna E Ford, Susanne M Richardson, MS RAC, Suzanne N Vallez, Tajah L Blackburn, Tamara M Casselman, Tamara M Felton, Tamika D Cathey, Tamil Arasu, PhD, Tammara A Stephens, Tara G Bizjak, Tara R Gooen, Temar Q Williams, Teresa C Thompson, Teresa I Navas, Terri L Dodds, Thai D Truong, Thao Le, Theresa L Stewart, Thomas E Friel, Thomas J Arista, Thuy T Nguyen, LCDR, Timothy T Kapsala, Tomika L Bivens, Tonia F Bernard, Torrance J Slayton, Toyin B Oladimeji, Tracy R Ball, Trang N Cox, Trang P Nguyen, Tricia S Martinez, Troy C Quander, Truong Xuan Nguyen (Andy), Tsedenia Woldehanna, Uttaniti Limchumroon (Tom), Valerie Jgrecek Trinh, Vanessa E Coulter, Verdell Nelson, Veronica Fuentes, MS, Vickie J Kanion, Vicky C Stoakes, Victor Spanioli, Victoria A Wagoner, Victoria L Palmer, Vincent Thomas, Viviana Matta, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wayne T Smith, Wei Hua Emily Wu, Whitney F Hook, William A Warnick, William F Lagud, Jr, William J Leonard, William V Millar, Xiaoxiao Pan, PhD, Xiomara Copeland, Xuhong Li, Yiyue Zhang (nmi), PhD, Young M Choi, PhD, Yuan Chia Kuo, Yumi J Hiramine, Yun Wu, PhD, Yvins Dezan, Zhao Wang, PhD, Zhenzhen Liu, PhD

Bonita S Chester's Documents

Publish Date Document Type Title
July, 2015 FDA 483 Response The Ritedose Corporation - Form 483R, 2015-08-06
April, 2017 FDA 483 Response Medi-Fare Drug - Form 483R, 2019-03-18
February, 2014 FDA 483 Stewart Compounding Pharmacy - Form 483, 2014-02-26
March, 2002 FDA 483 Societal CDMO Gainesville, LLC - Form 483, 2002-03-07
August, 2018 FDA 483 Cantrell Drug Company - Form 483, 2018-08-22
September, 2000 FDA 483 ICSL Clinical Studies Ltd. - Form 483, 2000-09-28
June, 2018 EIR Biogen MA Inc. - EIR, 2018-06-13
July, 2005 FDA 483 Response Thomas P. Gross MD - Form 483R, 2005-08-11
April, 2003 FDA 483 Evangeline G Gonzalez MD - Form 483, 2003-04-22
May, 2008 FDA 483 Colby H Grossman MD - Form 483, 2008-05-15
August, 2019 EIR Charles River Laboratories, Inc. DBA Charles River, Endosafe - EIR, 2019-08-20
July, 2015 FDA 483 The Ritedose Corporation - Form 483, 2015-07-31
October, 2001 EIR Terve Sina Wellness Inc. - EIR, 2001-10-12
February, 2010 FDA 483 Verson, Reinaldo D. - Form 483, 2010-02-03
March, 2018 EIR Patheon API Manufacturing, Inc. - EIR, 2018-03-30
June, 2013 FDA 483 Medi-Fare Drug - Form 483, 2013-06-21
June, 2002 EIR Janssen Pharmaceuticals, Inc. - EIR, 2002-06-13
September, 2014 FDA 483 Triangle Compounding Pharmacy Inc - Form 483, 2014-09-22
January, 2013 FDA 483 Medi-Fare Drug - Form 483, 2013-01-18
July, 2015 EIR The Ritedose Corporation - EIR, 2015-07-31
July, 2003 EIR Uquifa Italia SpA - EIR, 2003-07-02
July, 2003 FDA 483 Response Uquifa Italia SpA - Form 483R, 2003-07-31
January, 2019 EIR Albemarle U.S. Inc - EIR, 2019-01-25
April, 2019 FDA 483 The Compounding Pharmacy - Form 483, 2019-04-08
February, 2010 FDA 483 Response Verson, Reinaldo D. - Form 483R, 2010-02-26
September, 2005 EIR Mikart, LLC - EIR, 2005-09-16
September, 2009 FDA 483 Dennis M Marcus, M.D. - Form 483, 2009-09-28
August, 2015 FDA 483 PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma - Form 483, 2015-08-20
January, 2003 FDA 483 Benjamin F. Lewis, MD - Form 483, 2003-01-17
November, 2014 EIR Patheon API Manufacturing, Inc. - EIR, 2014-11-26
April, 2004 EIR Mikart, LLC - EIR, 2004-04-01
September, 2015 EIR Hospira, Inc. - EIR, 2015-09-24
July, 2016 FDA 483 Nephron Sterile Compounding Center, LLC - Form 483, 2016-07-06
January, 2017 EIR Nephron Sterile Compounding Center, LLC - EIR, 2017-01-20
April, 2002 FDA 483 Cell Dynamics, LLC - Form 483, 2002-04-03
February, 2008 FDA 483 Span Packaging Services LLC dba Multi-Pack Solutions - Form 483, 2008-02-19
April, 2003 FDA 483 Response Evangeline G Gonzalez MD - Form 483R, 2004-05-24
June, 2012 FDA 483 V-SAB Medical Labs, Inc. - Form 483, 2012-06-22
April, 2015 EIR Tianish Laboratories Private Limited - EIR, 2015-04-17
February, 2010 EIR Verson, Reinaldo D. - EIR, 2010-02-03
September, 2013 FDA 483 Eisai Inc - Form 483, 2013-09-13
March, 2010 EIR LifePoint, Inc. - EIR, 2010-03-31
January, 2004 FDA 483 Response Teva Pharmaceutical Works Private Limited Company - Form 483R, 2004-04-09
August, 2015 EIR Patheon API Services, Inc. - EIR, 2015-08-28
May, 2006 FDA 483 Bausch & Lomb Inc - Form 483, 2006-05-15
September, 2000 FDA 483 Response Maria J. Gutierrez, MD - Form 483R, 2000-10-18
December, 2018 EIR Exela Pharma Sciences, LLC. - EIR, 2018-12-19
September, 2015 FDA 483 Hospira, Inc. - Form 483, 2015-09-24
November, 2013 FDA 483 Nature's Pharmacy & Compounding Center - Form 483, 2013-11-22
April, 2010 FDA 483 AAIPharma Services - Form 483, 2010-04-16
February, 2000 EIR ZLB Bioplasma, Inc. - EIR, 2000-02-24
September, 2000 EIR Maria J. Gutierrez, MD - EIR, 2000-11-09
July, 2003 FDA 483 Uquifa Italia S.p.A. - Form 483, 2003-07-02
May, 2012 EIR Neopharm Labs Inc - EIR, 2012-05-01
April, 2011 EIR Alberto J Montero MD - EIR, 2011-04-21
April, 2011 FDA 483 Alberto J Montero MD - Form 483, 2011-04-21
November, 2015 EIR Solvay USA Inc. - EIR, 2015-11-13
September, 2006 FDA 483 7 OAKS PHARMACEUTICAL CORPORATION - Form 483, 2006-09-25
April, 2003 EIR Evangeline G Gonzalez MD - EIR, 2003-04-22
January, 2003 EIR Benjamin F. Lewis, MD - EIR, 2003-01-17
September, 2003 FDA 483 The Ritedose Corporation - Form 483, 2003-09-12
May, 2008 EIR Colby H Grossman MD - EIR, 2008-05-15
July, 2013 FDA 483 The Procter & Gamble Manufacturing Company - Form 483, 2013-07-18
August, 2017 FDA 483 Response Stanley Specialty Pharmacy Compounding and Wellness Center - Form 483R, 2017-08-22
June, 2019 FDA 483 Hybrid Pharma LLC - Form 483, 2019-06-24
April, 2017 EIR Nephron Sterile Compounding Center, LLC - EIR, 2017-04-21
May, 2000 FDA 483 Marc C. Gittelman, M.D. - Form 483, 2000-05-31
December, 2013 EIR Alcami Carolinas Corporation - EIR, 2013-12-20
July, 2018 FDA 483 Sato Pharmaceutical Co., Ltd. - Form 483, 2018-07-03
June, 2011 EIR Capsugel Manufacturing Inc. (Owned by Lonza) - EIR, 2011-06-29
December, 2009 FDA 483 Solvay USA Inc. - Form 483, 2009-12-04
May, 2006 FDA 483 Bausch & Lomb Inc - Form 483, 2006-05-15
August, 2017 EIR Stanley Specialty Pharmacy Compounding and Wellness Center - EIR, 2017-08-04
March, 2013 FDA 483 Triangle Compounding Pharmacy Inc - Form 483, 2013-03-01
April, 2018 FDA 483 Guardian Pharmacy Services - Form 483, 2018-04-23
November, 2011 FDA 483 Pharmalogic South Carolina, LLC - Form 483, 2011-11-03
April, 2019 EIR Patheon API Services, Inc. - EIR, 2019-04-12
March, 2000 EIR BCA International, Inc. - EIR, 2000-03-21
May, 2000 EIR Marc C. Gittelman, M.D. - EIR, 2000-06-06
February, 2000 FDA 483 ZLB Bioplasma, Inc. - Form 483, 2000-02-24
July, 2016 FDA 483 Stanley Specialty Pharmacy Compounding and Wellness Center - Form 483, 2016-07-07
January, 2004 EIR Teva Pharmaceutical Works Private Limited Company - EIR, 2004-03-25
September, 2009 EIR Dennis M Marcus, M.D. - EIR, 2009-09-28
April, 2014 EIR The Ritedose Corporation - EIR, 2014-04-17
August, 2000 EIR Sheetal Sharma - EIR, 2000-08-02
March, 2002 EIR Societal CDMO Gainesville, LLC - EIR, 2002-03-07
April, 2017 FDA 483 Nephron Sterile Compounding Center, LLC - Form 483, 2017-04-21
December, 2006 EIR LifePoint, Inc. - EIR, 2006-12-18
February, 2018 FDA 483 Hospira, Inc. - Form 483, 2018-02-02
April, 2019 FDA 483 Patheon API Services, Inc. - Form 483, 2019-04-12
August, 2017 FDA 483 Stanley Specialty Pharmacy Compounding and Wellness Center - Form 483, 2017-08-04
November, 2015 FDA 483 Solvay USA Inc. - Form 483, 2015-11-13
August, 2021 FDA 483 King Bio Inc - Form 483, 2021-08-12
May, 2002 EIR Carr, Albert A./Md - EIR, 2002-05-28
October, 2021 FDA 483 Stanley Specialty Pharmacy Compounding and Wellness Center - Form 483, 2021-10-01
April, 2002 EIR Cell Dynamics, LLC - EIR, 2002-04-03
June, 2017 FDA 483 SKNV - Form 483, 2017-06-26
October, 2012 EIR IDT Biologika GmbH - EIR, 2012-10-18

Experience Redica Systems’ NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • 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.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

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