FDA Investigator Cynthia F Kleppinger, MD

Cynthia F Kleppinger, MD has inspections in 5 countries as of 29 Sep 2023. Cynthia F Kleppinger, MD has collaborated with a combinined 1812 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
22
Last Inspection Date:
29 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Denmark, Belgium, Canada, Czechia
Co-Investigator(s):
Addam S Reynolds, Alexandra B Pitkin, Andrea A Branche, Andria L Kuhlman, Anna M Brannen, Annet R Rajan, Anthony C Warchut, Anthony J Donato, Anthony N Onianwa, Barbara M Frazier, Barbara T Carmichael, Bei Yu, Betsy C Galliher, Brandy D Brown, Byungja E Marciante, Carlos Chavez, Cassandra L Abellard, Cheryl A Grandinetti, Christina P Burkhart, Christopher Janik, Claudia Mperez Kasmarski, Cynthia L Rakestraw, Daniel J Grabicki, Darin S Wiegers, Dawn C Olenjack, Deborah A Greco, Diane C Thibodeau, Douglas C Kovacs, Eileen J Bannerman, Eileen T Monaghan, Emest F Bizjak, Erica L Nicoll, Ethan P Stegman, Frederick Razzaghi, Gam S Zamil, Geoffrey K Kilili, Guerlain Ulysse, Hugh M Mcclure, II, James P Mcevoy, Janete F Guardia, Jawaid Hamid, Jean M Mulinde, MD, Joel D Martinez, Joey V Quitania, John J Thibodeau, Jonee J Mearns, Joseph F Owens, Joy Rkozlowski Klena, Karen M Cooper, Kassa Ayalew, MD, Kathryn Suttling, Kelli F Dobilas, Kimberly A Dux, Kristy A Zielny, Lakecha N Lewis, Langer, LCDR Margaret E Digennaro, Leon L Crawley, Linda Thai, Ling Yang, Lisa Shin, Lori A Gioia, M Patriciaurphy Murphy, Marcelo O Mangalindan, Jr, Marcia A Worley, Marea K Harmon, Mark R Mcclain, Matthew C Watson, Maya M Davis, Miah Jung, Michael Serrano, Michelle D Haamid, Michelle M Moe, Michelle M Noe, Min Lu, Nancy L Rolli, Nicole C Victoria, PhD, Nicole M Bell, Nina Yang, Patrick D Stone, MS, Paul L Bellamy, Peter R Lenahan, Rachel M Skeete, Richard W Berning, Ruark Lanham, Sereen Gmorgan Murray, Sharon K Gershon, Sharon L Matson, Shirley S Wen, Stephen R Souza, Stephen T Hansen, Susanne M Richardson, MSc RAC ELS, Suzanne G Demko, Tania E Vizcaino, Tracey L Harris, Tracy R Ball, Truong Xuan Nguyen (Andy), Vanessa E Coulter, Victoria M Daddeo, Virgilio F Pacio, CSO, William P Tonkins, Yvette Mlacour Davis

Cynthia F Kleppinger, MD's Documents

Publish Date Document Type Title
February, 2012 EIR Premier Research International LLC. - EIR, 2012-02-17
March, 2013 EIR Burzynski Research Institute - EIR, 2013-03-15
February, 2012 FDA 483 Premier Research International LLC. - Form 483, 2012-02-17
March, 2013 FDA 483 Response Stanislaw R Burzynski, MD - Form 483R, 2013-04-08
June, 2015 FDA 483 Magdalena Petkova - Form 483, 2015-06-05
June, 2009 FDA 483 Pfizer Inc. - Form 483, 2009-06-03
February, 2016 EIR PPD, Inc., part of Thermo Fisher Scientific - EIR, 2016-02-25
November, 2015 FDA 483 Duke Clinical Research Institute - Form 483, 2015-11-04
December, 2019 EIR Boehringer Ingelheim Pharmaceuticals, Inc. - EIR, 2019-12-12
March, 2013 FDA 483 Burzynski Research Institute - Form 483, 2013-03-15
March, 2013 EIR Stanislaw R Burzynski, MD - EIR, 2013-03-15
February, 2015 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2015-02-23
March, 2013 FDA 483 Response Burzynski Research Institute - Form 483R, 2013-04-05
August, 2018 FDA 483 Kathryn Lucas, M.D. - Form 483, 2018-08-27
March, 2013 FDA 483 Stanislaw R Burzynski, MD - Form 483, 2013-03-15
December, 2019 FDA 483 Boehringer Ingelheim Pharmaceuticals, Inc. - Form 483, 2019-12-12
June, 2009 EIR Pfizer Inc. - EIR, 2009-06-03
February, 2017 FDA 483 Karyopharm Therapeutics Inc. - Form 483, 2017-02-08
June, 2016 EIR Chhavi Chadha, MD - EIR, 2016-06-27
June, 2017 EIR Medpace Inc - EIR, 2017-06-08
November, 2015 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2015-11-19
June, 2016 FDA 483 Response Chhavi Chadha, MD - Form 483R, 2016-07-13
April, 2016 EIR Kathryn Lucas, M.D. - EIR, 2023-08-09
April, 2016 FDA 483 Kathryn Lucas, M.D. - Form 483, 2016-04-08
August, 2018 EIR Kathryn Lucas, M.D. - EIR, 2018-08-27
July, 2016 FDA 483 Zubin Punthakee, MD - Form 483, 2016-07-22

Experience Redica System's 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