FDA Investigator Mark W Babbitt

Mark W Babbitt has conducted inspections on 187 sites in 5 countries as of 22 Oct 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
187
Last Inspection Date:
22 Oct 2019
Investigator Role:
FDA Investigator
Redica ID:
100006992
Countries of Inspections:
United States of America, Belgium, Canada, Mexico, Netherlands
FDA Investigators that have inspected at least one site in common with Mark W Babbitt:
Aaron J Poloni, Alan D Grupe, Alan R Condon, Alexander M Kay, Amanda L Fyles, Amir Alavi, Amy R Glynn, Anderson, Andrea A Branche, Andrew K Haack, PhD, Anita Narula, PhD, Anya Dlockett Evans, Ashar P Parikh, Ashutosh Rao, PhD, Astrida B Mattson, Ava M Bowman, Avery J Dennis, Barbara Janine Breithaupt, Barbara T Carmichael, Bichsa T Tran, Binh T Nguyen, Bradley Dworak, PhD, Brenda K Alford, Brentley S Collins, Bruce R Burrell, Bryce E Mansfield, Carl A Anderson, Carla J Lundi, Carrie A Hughes, Caryn M Mcnab, Catherine J Laufmann, CDR Rochelle B Young, RPh, MSA, Ce'nedra M Martin, Celeta S Coves, Charles L Larson, Christian D Lynch (CDL), Christine A Harman, PhD, Christopher R Czajka, Clint R Van Blaricom, Connie P Rezendes, Crystal A Harlan, Crystal Monroy, Cynthia J Lee, MS, Dam S Barkans, Dan G Eisenbrey, Daniel A Congdon, David Serrano, Dawn E Barkans, Deborah A Nebenzahl, Dennis R Hudson, Devon M Shoop, Dianna D Wardlow Dotter, Dianne B Latona, Dirk L Lincoln, Dolores E Price, Don A Brunssen, Don H Bark, PhD, Donald W Jehn, Dustin R Abaonza, Edward D Harris, Edwin Melendez, Eileen A Liu, Elizabeth Ad Girard, Elizabeth E Hart (ASCP), MT, Eric C Milstead, Eric L Dong, BS, Eric S Myskowski, Eric Zhu, Garrad R Poole, Gene D Arcy, Gerard Pde Leon, Gina C Collins, Gloria J Baca, MS, Gordon T Wales, Graham N Giesen, Hanna L Potter, Heika R Bounds, Heika R Tait, Herminio C Francisco, Himanshu Gupta, PhD, Homero W Aguilar, Hossein Khorshidi, PhD, Hugh A Grimoldby, Humberto Z Gomez, Iris C Macinnes, Jacek Cieslak, PhD, Jacob N Hamilton, Jacqueline Mdiaz Albertini, James B Arnett, James C Henry, James D Hildreth, James R Fleckenstein, James S Cartwright, Jane M Kreis, Janet B Abt, Jean Brewer, Jean C Colon Lopez, Jeffrey D Varelman, Jeffrey J Leclair, Jeffrey N Gerdes, Jeffrey P Raimondi, Jeffrey W Shrifter, DPM, Jennifer A Jones, Jennifer L Bridgewater, Jennifer M Gogley, Jessica B Clark, Jessica L Walters Moell, Jinkee Mvila Binayug, Jinnie Kokiatkulkij, Joel D Martinez, Joey V Quitania, Johann M Fitch, John A Gonzalez, John E Emmert, John W Banks, Joshua P Wireman, Julian C Hanson, Julie A Stocklin, Kaarin M Slotte, Kaitlyn R Kornberg, Kari M Johansen, Katherine E Jacobitz, Katherine L Arnold, Kathryn A Krentz, Kellie L Westerbuhr, Kelvin Cheung, Kenneth O Gee, PhD, Kham Phommachanh, Kim Lthomas Cruse, Kimberly A Dux, Kristin M Abaonza, Lakecha N Lewis, Laura Kathryn, Laurel A Beer, Lauren E Swantko, Laurissa S Flowers, LCDR Debra Emerson, LCDR Ismael Olvera, IV, LCDR Jennifer H Rhyu, Leonard H Lavi, Lesley A Swanson, Leya A Grosch, Li Hongpaul Yeh, PhD, Lillian S Wu, Lilly O Barton, Linda S Leja, Ling Yu L Liu, Linh Tu, Lisa K Capron, Lori J Silverstein, Lynda L Perry, PhD, Marc A Jackson, Jr, Marcus F Yambot, Maria C Crowley, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Marilyn S Babu, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark C Saale, Mark E Imsland, Mark L Collins, Mary E Farbman, PhD, Maxine H Wong, Mei Chen Mu, Michael T Cyrus, Mihaly S Ligmond, Mikel T Wright, Omotunde O Osunsanmi, Orval D Mcintire, Othello G Capangpangan, Pal S Mayasandra, Paul M Kawamoto, Paula A Trost, Peter Kessler, PhD, Philip F Istafanos, DMV, MS, Prabhu P Raju, Rachel C Stanton, Randy L Self, Rebecca Rodriguez, Rebecca T Davis, Richard T Riggie, Robert A Williams, Robert B Shibuya, MD, Robert C Coleman, Robert D Tollefsen, Rocco C Black, Roger F Zabinski, Ruben C Ayala, PharmD, S Lori Brown, PhD MPH, Samson O Oluseye, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Sarah A Hassas, Selene T Torres, Sharon I Gundersen, Sherri N Rohlf, MD, Sherryl Stoltenow, Sonya L Karsik, RAC, Srinivas R Chennamaneni, PhD, Stanley B Eugene, BS, BME, Stephen D Weagant, Stephen R Souza, Stuart W Russell, Sue Lee Chan, Sunitha K Rajaram, PhD, Sunny R Muir, Susan F Laska, MS, Tamala P Bogan, Tamala P Magee, Terri L Dodds, Thea C Grome, Thomas J Arista, Tina S Roecklein, Tracy K Li, Truong Xuan Nguyen (Andy), Uttaniti Limchumroon (Tom), Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Veronica L Bush, Virgilio F Pacio, CSO, Walden H Lee, Wendy G Tan, PhD, William A Burkey, Wr Bowman, Xiaohui Shen, Xiaojun Yan, Xiomara Copeland, Yiyue Zhang (nmi), PhD, Young M Choi, PhD, Young M Yoon, Yvonne Y Wu

Mark W Babbitt's Documents

Publish Date Document Type Title
November, 2017 EIR Premier Clinical Research, LLC - EIR, 2017-11-29
January, 2015 EIR Alaska Regional Hospital IRB - EIR, 2015-01-28
November, 2017 FDA 483 Response Premier Clinical Research, LLC - Form 483R, 2018-02-05
April, 2015 FDA 483 Gregory B. Hammer, M.D. - Form 483, 2015-04-17
August, 2012 FDA 483 Michael E. Ring, MD - Form 483, 2012-09-13
March, 2016 FDA 483 Response Richard A. Nathan, D.O. - Form 483R, 2016-04-18
October, 2012 FDA 483 Pathology Associates Medical Laboratories, LLC - Form 483, 2012-10-16
July, 2018 FDA 483 Jason J. Lukas, M.D. - Form 483, 2018-07-13
August, 2012 FDA 483 Response Michael E. Ring, MD - Form 483R, 2012-09-14
March, 2014 FDA 483 John M. Wise, M.D. - Form 483, 2014-03-28
June, 2017 FDA 483 Rajasekaran Annamalai, M.D. - Form 483, 2017-06-09
October, 2010 FDA 483 East West Tea Company, LLC - Form 483, 2010-10-27
September, 2014 EIR Santa Clara Valley Medical Center IRB - EIR, 2014-09-19
September, 2014 FDA 483 Santa Clara Valley Medical Center IRB - Form 483, 2014-09-19
August, 2018 FDA 483 Jonathan G. Greenburg, D.D.S. - Form 483, 2018-08-10
October, 2019 FDA 483 Neelakantan Anand, MD - Form 483, 2019-10-24
February, 2019 FDA 483 Robert E. Peters, M.D., Ph.D - Form 483, 2019-02-15
March, 2019 FDA 483 Kalispell Regional Medical Center, Inc. IRB #4 - Form 483, 2019-03-29
August, 2019 FDA 483 Michael C. Heinrich, M.D. - Form 483, 2019-08-16
June, 2016 EIR Sarepta Therapeutics Inc - EIR, 2016-06-23
June, 2017 EIR Rajasekaran Annamalai, M.D. - EIR, 2017-06-09
June, 2011 FDA 483 Response Snokist Growers - Form 483R, 2011-06-22
June, 2011 FDA 483 Snokist Growers - Form 483, 2011-06-02
March, 2017 FDA 483 Gerrit J. Bouma, MD - Form 483, 2017-03-10
April, 2016 FDA 483 Martha I. Buitrago, M.D. - Form 483, 2016-04-01
January, 2015 FDA 483 Alaska Regional Hospital IRB - Form 483, 2015-01-28
April, 2016 EIR Martha I. Buitrago, M.D. - EIR, 2016-04-01
March, 2016 EIR Richard A. Nathan, D.O. - EIR, 2016-03-30
May, 2013 FDA 483 Response Kootenai Medical Center IRB - Form 483R, 2013-06-20
September, 2014 FDA 483 Response Santa Clara Valley Medical Center IRB - Form 483R, 2014-10-06
July, 2019 FDA 483 Jay E. Gladstein, MD - Form 483, 2019-07-12
November, 2017 FDA 483 Premier Clinical Research, LLC - Form 483, 2017-11-29
August, 2012 EIR Michael E. Ring, MD - EIR, 2012-08-23
May, 2013 FDA 483 Kootenai Medical Center IRB - Form 483, 2013-05-29
March, 2016 FDA 483 Richard A. Nathan, D.O. - Form 483, 2016-03-30
October, 2012 EIR Pathology Associates Medical Laboratories, LLC - EIR, 2012-10-16
April, 2014 FDA 483 Jubilant HollisterStier LLC - Form 483, 2014-04-15
September, 2017 FDA 483 Roland B Walter MD - Form 483, 2017-09-15
May, 2013 EIR Kootenai Medical Center IRB - EIR, 2013-05-29
October, 2019 EIR SEAGEN INC. - EIR, 2019-10-04
March, 2014 EIR John M. Wise, M.D. - EIR, 2014-03-28
November, 2017 FDA 483 William Philip Werschler, MD, FAAD, FAACS - Form 483, 2017-11-29
July, 2017 EIR Sattva S. Neelapu, M.D. - EIR, 2017-07-28

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