FDA Investigator James M Odonnell

James M Odonnell has inspections in 20 countries as of 11 Oct 2023. James M Odonnell has collaborated with a combinined 3542 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
391
Last Inspection Date:
11 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Germany, Canada, France, Italy, United Kingdom of Great Britain and Northern Ireland, Japan, China, Brazil, Costa Rica, Taiwan, Israel, Sweden, Ireland, Denmark, Belgium, Spain, Netherlands, Czechia
Co-Investigator(s):
A Williams, Aaron L Dunbar, Akbar J Zaidi, Alan C Gion, Allison E Sincek, Allison M Mcgloin, Allison M Scheck, Althea A Williams, Amy M Cramer, Anastasia M Shields, Andrea A Branche, Andrew Saunders, Arthur S Williams, Jr, Ashleigh P Barkans, Ashleigh P Wodushek, Benjamin W Anderson, Bill Tacket, Jr, Brandi L Garbutt, Brandon J Brookens, Brandon L Mariner, Brandon M Kurjanowicz, Brian M Palermo, Brian R Yaun, Brian S Keefer, Brittani N Franklin, Calvin K Cook, Calvin W Edwards, Carl E Lovrich, Cary Greene, Catherine J Laufmann, CDR Michael J Mero, CDR Sean T Creighton, Celia L Hutchinstein, Charles E Idjagboro, Charles L Larson, Charles M Spyr, Cheryl D Mccall, Cheryl G Scott, Christina K Theodorou, Christine I Shaw, Christine M Parmentier, Clotia Cabbey Mensah, Crayton Lee, Cynthia L Rakestraw, Cynthia T Cain, Daniel J Lahar, Daniel J Mechenbier, Daniel R Rammariello, Daniel R Tammariello, Darren S Morgan, Dauksism, David J Gasparovich, David P Vanhouten, Dawn M Braswell, Deborah A Greco, Deborah G Haney Cozzone, Dell S Moller, Dennis L Doupnik, Dennis R Hock, Dessa A Antoine, Dianiris C Ayala, Donna Ltartaglino Besone, Dorathy M Eischen, Edward P Potter, Edward R Kay, Elizabeth B Griffin, Elizabeth D Connell, Elkins, Emmanuel A Dimaano, Jr, Eric L Vangraafeiland, Eric S Myskowski, Eric S Pittman, Eric W Anderson, Erica L Nicoll, Evelyn Taha, Frank J Marciniak, Frank Verni, Gamal A Norton, George T Allen, Jr, Gerald W Kopp, Gess, Gladys B Casper, Grace E Mcnally, Gregory E Beichner, Harperd, Iris C Macinnes, Jacob M Dyer, Jacqueline S Warner, James A Beaulieu, James M Donner, James O Beaulier, James P Mcevoy, James R Montero, James W Leonette, Janet Pulver, Javonica F Penn, Jesse A Vazquez, Jessica M Monteiro, Jocelyn C Turner, John A Sciacchitano, Joseph R Hatcher, Joseph T Dougherty, Joshua E Yao, Joshua J Silvestri, Jude C Dikes, Judith A Paterson, Juliana M Badalucco, Julianne C Mccullough, Justin A Hefferman, K Gonzlez, Karen A Coleman, Karen A Spencer, Karen S Anthony, Karl D Hezel, Katelyn A Staub, Katelyn Astaub Zamperini, Kelvin Cheung, Kim M Downing, Kimberly Lewandowski Walker, Kinh Q Mac, Kirk A Dymbrowski, Kristina J Donohue, Laureen M Geniusz, LCDR Susan E Polifko, LCDR William H Bender, Leo J Lagrotte, Leonard H Lavi, Lindsey L Kirsh, Lisa A Warner, Loretta Nemchik, Lori A Carr, Lori A Lahmann, LT John M Mastalski, LTJG Bradley E Benasutti, Maida Henesian (NMI), Maney P Sturgill, Marc A Jackson, Jr, Marjorie Davis, Marjorie L Davis, Mark E Chan, Mary E Storch, Mary R Kirker, Maryam Tabatabaie, Mastalskij, Matthew H Pitts, Matthew J Sienko, Maureen A Wentzel, Melissa J Holz, Michael J Diskin, Michael J Nerz, Michael K Larson, Michael L Casner, Michelle L Johnson, Minerva Rogers, Minh D Phan, Mishelle L Harriger, Monica Burgos Garcia, Monica Cburgos Garcia, Msdap Gonzlezk, Nebil A Oumer, Nicholas Z Lu, Norman Wong, Paige E Shelborne, Patricia A Mcilroy, Patrick C Klotzbuecher, Paul M Kawamoto, Pauline N Logan, Pifer, Ramanda C Gregory, Reginald Walker, Richard Jay Tucker, RS, Richard K Vogel, Richard L Rutherford, Robert Rodriguez, Ronald A Stokes, Rosanna M Goodrich, Roy Baby, Sargum C Sood, Sean D Duke, Shafiq S Ahadi, Shannon A Gregory, Sierra M Shockley, Sony Mathews, State Agency, Stephen D Eich, Steven E Kane, Syeda N Mahazabin, Talmane J Fisher, Tammy M Phillips, Teresa K Kastner, Thai T Duong, Thomas E Friel, Thomas R Withers, Tiffani D Wilson, Tiki J Dixon, Travers, Travis R Hunt, Van Cliff, Victor Spanioli, William A Warnick, William R Chang, Xiaojun Yan

James M Odonnell's Documents

Publish Date Document Type Title
November, 2010 EIR Zoll Manufacturing Corp. - EIR, 2010-11-18
September, 2014 EIR D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. - EIR, 2014-09-12
December, 2011 EIR Interlectric Corp - EIR, 2011-12-06
March, 2015 FDA 483 Weba Medizintechnik GmbH & Co. - Form 483, 2015-03-11
December, 2001 EIR DeVilbiss Healthcare LLC - EIR, 2001-12-19
November, 2013 FDA 483 Cima Technology Inc - Form 483, 2013-11-12
March, 2014 FDA 483 Gemore Technology Co., Ltd. - Form 483, 2014-03-20
October, 2010 FDA 483 Best Nomos - Form 483, 2010-10-21
June, 2011 FDA 483 Philips Respironics, Inc. - Form 483, 2011-06-24
December, 2011 FDA 483 Interlectric Corp - Form 483, 2011-12-06
March, 2011 FDA 483 ClearCount Medical Solutions, Inc. - Form 483, 2011-03-11
November, 2010 FDA 483 Thermal Therapeutic Systems, Inc. % Pittsburgh Life Sciences - Form 483, 2010-11-10
September, 2015 FDA 483 Bionen S.r.l. - Form 483, 2015-09-17
May, 2015 FDA 483 Pihsiang Machinery Mfg Co Ltd - Form 483, 2015-05-07
April, 2009 FDA 483 Circadiance LLC - Form 483, 2009-04-01
August, 2015 FDA 483 Summit Medical Ltd. - Form 483, 2015-08-05
January, 2012 FDA 483 Zoll Manufacturing Corp. - Form 483, 2012-01-19
June, 2003 EIR Xodus Medical Inc - EIR, 2003-06-26
September, 2011 FDA 483 Karl Leibinger Medizintechnik GmbH & Co. KG - Form 483, 2011-09-28
August, 2003 EIR Philips Respironics, Inc. - EIR, 2003-08-15
August, 2014 FDA 483 CHA'S ELECTRONIC INDUSTRIES (SHENZHEN) COMPANY - Form 483, 2014-08-07
June, 2003 FDA 483 Xodus Medical Inc - Form 483, 2003-06-26
October, 2003 FDA 483 Micor, Inc. - Form 483, 2003-10-23
April, 2013 EIR Unilife Medical Solutions, Inc. - EIR, 2013-04-19
March, 2007 EIR Calumet Karns City Refining LLC - EIR, 2007-03-27
July, 2012 FDA 483 Nuvo, Inc. - Form 483, 2012-07-16
December, 2010 FDA 483 Capintec Inc - Form 483, 2010-12-08
April, 2011 FDA 483 United Metal Fabricators Inc - Form 483, 2011-04-21
July, 2009 FDA 483 Draeger Medical Systems, Inc. - Form 483, 2009-07-09
March, 2010 EIR Zoll Manufacturing Corporation - EIR, 2010-03-11
September, 2003 FDA 483 Jostra Ag - Form 483, 2003-09-24
December, 2001 FDA 483 DeVilbiss Healthcare LLC - Form 483, 2001-12-19
April, 2010 EIR Neurolign USA, Llc - EIR, 2010-04-20

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