FDA Investigator Stephanie L Shapley

Stephanie L Shapley has inspections in 5 countries as of 15 Sep 2023. Stephanie L Shapley has collaborated with a combinined 2944 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
Last Inspection Date:
15 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
United States of America, Russian Federation, Austria, Finland, Italy
Adams, Amber G Chung, Ana P Barido, Anthony J Grace, Anthony W Hite, Anthony W Lee, Antoine El Hage, PhD, Arindam Dasgupta, PhD, Ashley L Reiber, Atul J Agrawal, Austin B Appler, Barbara A Crowl, Barbara A Gullick, Barbara J Holladay, Barbara J Rincon, Barbara Janine Breithaupt, Barbara M Frazier, Braedyn K Kromer, Brandon L Mariner, Brian M Palermo, Bruce C Kovak, Byungja E Marciante, Candice C Mandera, Candice J Cortes, Chaltu N Wakijra, Charles A Snipes, PhD, Charles M Kerns, BLT DO, Charles R Bonapace, PhD, Christian D Lynch (CDL), Christine M Smith, Christine M Whitby, CSO, Christine Mwhitby Smith, Christopher A Hairr, Courtney N Long, Cynthia A Harris, MD, RN, Cynthia Jim, CSO, Cynthia L Rakestraw, Da Lin Yao, MD, PhD, Daniel R Azar, Daniel T Lee, David A Oluwo, David K Glasgow, David L Chon, Debra Bower, Dhaval H Patel, Diane T Bargo, Douglas A Campbell, Dr. Abhijit Raha, PhD, Dr. Mark J Seaton, PhD, Dr. Zhou Chen (nmi), MD PhD, Earl Echon, Edette J Newby, Edward P Potter, Ellen A Humphrey, Elvis D Morton, Emest F Bizjak, Eric L Dong, BS, Erin L Mcfiren, Erin M Mcdowell, Esaw, Gale L Glinecki, Gerald D Bromley, Jr, Gerald W Miller, Hector J Colon Torres, Hugh M Mcclure, II, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jaison J Eapen, James L Dunnie, Jr, James M Simpson, James W Leonette, Janet K White, Jeanne D Shaffer, Jessica D Nanini, John A Kadavil, PhD, John Dan, Jonathan R Campos, Jonathan W Chapman, Joseph W Matthews, Julie A Silberberg, Julie D Bringger, Justin A Hefferman, Jyoti B Patel, PhD, Kalavati Suvarna, PhD, Karen M Cooper, Keith M Reilly, Kellia N Hicks, Kenneth Nieves, Krista N Flores, Kurt A Brorson, PhD, Lakisha M Williams, LCDR Anastasia Mpiliafas Brown, Lori S Lawless, Lorraine L Chavis, LT Luis O Rodriguez, LT Melanie M Mayor, USPHS, Lucilla Facchin, Lynette P Salisbury, Marc S Neubauer, Marcellinus D Dordunoo, Marilyn M White, Martin D Green, PhD, Martin K Yau, PhD, Matthew M Henciak, Meghan Murphy, Melissa J Garcia, Merideth K Rose, Michael F Skelly, PhD, Mildred L Mccray, Monique Rac Lester, Natasha A Dezinna, Natasha A Harry, Natasha Gupta, Nebil A Oumer, Nichole J Chamberlain, Nilufer M Tampal, PhD, Norman K Starks, Nutan Mytle, Patricia A Morrow, Philip J Snoy, Pratik S Upadhyay, DDC, Pushpa S Jayasekara, Qin Xu, Rachel C Harrington, Richard Heath Coats, Robert B Shibuya, MD, Robert Durkin, Robert L Hummel, Rose M Ashley, Ruark Lanham, Sarah M Shannon, Sena G Dissmeyer, Sherry L Secrist, BLT DO, Stacey A Priest, State Agency, Stephanie I Shapley, Stephanie L Stapley, Stephanie Mangigian, MS/OSH, RN, Steven J Thurber, Steven P Donald, Susan M Jackson, Suzanne M Healy, Suzanne M Muchene, Suzanne Suzanne, Tamara N Champion, Tamika E Allen, RN, Theresa M Smedley, Thomas, Toyin B Oladimeji, Walter L Fava, Wanda Y Honeyblue, Wayne L Jefferson, William A Warnick, William H Linkroum, William L Bargo, Xikui Chen (nmi), PhD, Young M Yoon, Zhongren Wu

Stephanie L Shapley's Documents

Publish Date Document Type Title
October, 2002 FDA 483 Response Bioanalytical Systems Inc - Form 483R, 2002-11-08
September, 2010 FDA 483 Bioreliance Corporation - Form 483, 2010-09-07
May, 2009 FDA 483 Suco Inc - Form 483, 2009-05-21
September, 2008 FDA 483 Human Genome Sciences Inc - Form 483, 2008-09-04
November, 2004 EIR Fisher BioServices, Inc. - EIR, 2004-11-09
March, 2009 FDA 483 Woodhaven Pharmacy Services, LLC dba Remedi SeniorCare - Form 483, 2009-03-19
October, 2002 EIR Bioanalytical Systems Inc - EIR, 2002-10-30
October, 2008 FDA 483 Washington Biotechnology, Inc - Form 483, 2008-10-03
March, 2003 EIR Frank J. Criado, MD - EIR, 2003-03-14
August, 2003 FDA 483 Raphaelson, Marc I. - Form 483, 2003-08-28
August, 2003 FDA 483 Mylan Pharmaceuticals Inc. - Form 483, 2003-08-01
November, 2004 FDA 483 Response Fisher BioServices, Inc. - Form 483R, 2004-12-20
November, 2004 FDA 483 Fisher BioServices, Inc. - Form 483, 2004-11-09
February, 2005 FDA 483 Niel T. Constantine, Ph.D. - Form 483, 2005-02-04
June, 2007 FDA 483 Alberto R. Yataco, M.D. - Form 483, 2007-06-06
June, 2007 EIR Alberto R. Yataco, M.D. - EIR, 2007-06-06
June, 2008 FDA 483 Mercy Medical Center IRB - Form 483, 2008-06-24
December, 2006 FDA 483 Sitek Research Laboratories - Form 483, 2006-12-22
January, 2004 EIR Advarra IRB - EIR, 2004-01-09
February, 2009 FDA 483 Richard E. Ringel, M.D. - Form 483, 2009-02-03
February, 2009 EIR Richard E. Ringel, M.D. - EIR, 2009-02-03
December, 2004 FDA 483 William A. Blattner MD - Form 483, 2004-12-21
February, 2005 EIR Niel T. Constantine, Ph.D. - EIR, 2005-02-04
December, 2002 EIR Manjari Joshi, MD - EIR, 2002-12-19
August, 2003 FDA 483 Response MARC RAPHAELSON - Form 483R, 2003-08-28
April, 2003 FDA 483 Stimsoft Inc. - Form 483, 2003-04-30
February, 2009 FDA 483 Response Richard E. Ringel, M.D. - Form 483R, 2009-02-10
June, 2009 EIR Advarra IRB - EIR, 2009-06-04
August, 2003 EIR MARC RAPHAELSON - EIR, 2003-08-28
March, 2003 FDA 483 Response Frank J. Criado, MD - Form 483R, 2003-03-18
September, 2005 EIR BASI Gaithersburg, LLC - EIR, 2005-09-12
May, 2008 FDA 483 Izeen Pharma Inc - Form 483, 2008-05-20
March, 2003 FDA 483 Frank J. Criado, MD - Form 483, 2003-03-14
October, 2002 FDA 483 Bioanalytical Systems Inc - Form 483, 2002-10-30

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


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