FDA Investigator Jean M Kelahan

Jean M Kelahan has inspections in 3 countries as of 27 Sep 2023. Jean M Kelahan has collaborated with a combinined 3527 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:

Last Inspection Date:

27 Sep 2023

Investigator Role:

FDA Investigator

Redica ID:

100005192

Country:

United States of America, India

Co-Investigator(s):

A Williams, Addam S Reynolds, Alberto A Viciedo, Allen Lou, Amy L Singer, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Ann Marie Montemurro, Ann Marie Schofield, Annemarie B Randow, Annemarie Bodnar, Arindam Dasgupta, PhD, Atul J Agrawal, Barbara D Wright, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Burnell M Henry, Byungja E Marciante, Byungja E Mercuente, Byungja H Marciante, Byunja E Marciante, Cara M Minelli, Cary Greene, Charles J Chacko, Cheryl A Grandinetti, Christian D Lynch (CDL), Christina N Maurino, Christine M Cerenzio, Christopher J Adams, Creighton T Tuzon, Daniel J Grabicki, David H Smith, Dawa L Wydner, Dawn L Wydner, Dawn L Wyndver, Deborah B Nixon, Denise M Visco, Investigator, Dennis E Guilfoyle, PhD, Dhaval H Patel, Donald L Lech, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Guang Gao, PhD, Dr. Zhou Chen (nmi), MD PhD, E Marciante, Edward D Mcdonald, Edward Oshaughnessy, Eliezar Ramos, Emest F Bizjak, Emily A Walters, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Eufemia G Gonzalez, Frank J Marci, Frank J Marciniak, Gene D Arcy, George Pyramides, Gobiga Vanniyasingam, Guerlain Ulysse, Harperd, Helen B Ricalde, Helen Verdel, Herrmann, J David Doleski, Jacqueline A Shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James E Frye, Jean Blackston Hill, Jennifer A Bazergui, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, Joan A Loreng, Joanne Pryzbylik, Jonee J Mearns, Joseph F Mcginnis, RPh, Joseph L Despins, PhD, Joy R Kelna, Joy Rkozlowski Klena, Juanita P Versace, Julie D Bringger, Kara A Scheibner, PhD, Karen E D'orazio, Karen F Tomaziefski, Kassa Ayalew, MD, Keith M Reilly, Kelli F Dobilas, Kelly I Anderson, Kelly L Anderson, Kimberly M Bigler, King, Kinh Q Mac, Kristen E Rescigno, Kristina L Conroy, Kristy A Zielny, Krystal O Ogunremi, Kwong P Lee, Kyle D Covill, Lata C Mathew, PhD, Lauren L Vajo, LCDR Debra Emerson, Li Li, Liatte Kreuger, PharmD, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Marcelo O Mangalindan, Jr, Margaret M Sands, Maria Estrella, Marion Michaelis, Mariza M Jafary, Martha T Olone, Martin K You, Mary T Carden, Matthew A Spataro, Matthew Sparato, Mayar M Mussa, Meihong Liu, Melba T Rivera, Melba Trivera Clavell, Melissa A Freeman, Melissa A Zuppe, Melissa T Roy, Meredith L Sheridan, Meyer J Slobotsky, Meyer J Sobotsky, Meyer Slobotsky, Michael J Nerz, Michael R Klapal, Michael Serrano, Michael Skelly, Mike M Rashti, Mohsen Rajabi Abhari, FDA, Monica L Guitierrez, Monica L Gutierrez, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Vicland, Nicholas A Violand, Nina Yang, Niraj Mehta, Omotunde O Osunsanmi, Paul L Bellamy, Paula A Trost, Peter R Lenahan, Prabhu P Raju, Qiao Y Bobo, Regina Regina, Regina T Brown, Richard D Manney, Robert G Ruff, Robert W Jennings, Rodney T Allnutt, Rose M Ashley, Russell J Glapion, Sandra Kershaw, Sarah Adella Fave, Sarah Forney, Schultz, Sherri J Liu, Sheryl A Kochman, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sinai Davis, State Agency, Stephanie T Durso, Stephen D Brown, Susan M Jackson, Susant Hadman, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Tawny L Colling, Teresita C Mercado, Thomas J Arista, Tonia F Bernard, Tyanna N Hadley, Tynna N Hadley, Valerie C Reed, Valerie Reed, Wayne J Meyer, Willy A Orantes, Xiaohan Cai, PhD, Xiaoping Guan, Yvesna C Blaise, Zakaria I Ganiyu

Jean M Kelahan's Documents

Publish Date	Document Type	Title
December, 2003	FDA 483	Cordis Corporation - Form 483, 2003-12-04
December, 2003	EIR	Sanofi-Aventis U.S. LLC - EIR, 2003-12-08
August, 2007	FDA 483 Response	Labcorp Early Development Laboratories, Inc. - Form 483R, 2007-09-06
August, 2003	FDA 483 Response	Labcorp Early Development Laboratories, Inc. - Form 483R, 2003-08-19
April, 2001	FDA 483 Response	Bayshore Comm Hosp - Form 483R, 2001-07-12
December, 2004	EIR	Princeton Center for Clinical Research - EIR, 2004-12-13
May, 2000	FDA 483 Response	Princeton Medical Institute - Form 483R, 2000-05-15
May, 2001	FDA 483	EUSA Pharma (USA) Inc. - Form 483, 2001-05-23
April, 2001	EIR	Bayshore Comm Hosp - EIR, 2001-04-24
April, 2003	FDA 483 Response	Labcorp Drug Development - Form 483R, 2003-05-21
April, 2003	FDA 483 Response	Boghossian, Jack MD - Form 483R, 2003-04-09
January, 2001	FDA 483	Zeus Scientific, Inc. - Form 483, 2001-01-31
May, 2000	EIR	Princeton Medical Institute - EIR, 2000-05-03
April, 2000	EIR	Jeffrey Apter, M.D. - EIR, 2000-04-11
August, 2003	FDA 483	Labcorp Early Development Laboratories, Inc. - Form 483, 2003-08-06
October, 2003	FDA 483	Excelsior Medical LLC - Form 483, 2003-10-17
September, 1997	EIR	Jeffrey Apter, M.D. - EIR, 1997-09-24
August, 2002	EIR	Ingenix Pharmaceutical Services - EIR, 2002-08-15
May, 2001	EIR	Bayer HealthCare LLC - EIR, 2001-05-18
August, 2000	EIR	Nelson Laboratories Fairfield Inc. - EIR, 2000-08-03
March, 2002	EIR	Syneos Health Clinical, Inc. - EIR, 2002-03-13
January, 2001	FDA 483 Response	Zeus Scientific, Inc. - Form 483R, 2001-02-06
March, 2000	EIR	Merck, Inc. - EIR, 2000-03-27
August, 2005	FDA 483 Response	Shelhigh, Inc. - Form 483R, 2005-08-30
May, 2000	FDA 483	Princeton Biomedical Research, P.A. - Form 483, 2000-05-03
August, 2007	EIR	Labcorp Early Development Laboratories, Inc. - EIR, 2007-08-23
January, 2003	FDA 483	Hoffmann La Roche Inc - Form 483, 2003-01-09
June, 2003	EIR	Integra LifeSciences Corporation - EIR, 2003-06-19
May, 2002	FDA 483	Sanofi-Aventis U.S. LLC - Form 483, 2002-05-20
December, 2003	FDA 483 Response	Cordis Corporation - Form 483R, 2003-12-22
October, 2003	EIR	Excelsior Medical LLC - EIR, 2003-10-17
August, 2003	EIR	Labcorp Early Development Laboratories, Inc. - EIR, 2003-08-06
January, 2003	EIR	Hoffmann La Roche Inc - EIR, 2003-01-09
August, 2000	FDA 483	Nelson Laboratories Fairfield Inc. - Form 483, 2000-08-03
September, 2003	EIR	Labcorp Early Development Laboratories, Inc. - EIR, 2003-09-19
January, 2003	FDA 483 Response	Hoffmann La Roche Inc - Form 483R, 2003-01-27
August, 2002	FDA 483	Ingenix Pharmaceutical Services - Form 483, 2002-08-15
March, 2001	FDA 483	Elliot Frank Md - Form 483, 2001-03-26
March, 2003	EIR	Denker, Michael M.D. - EIR, 2003-03-13
August, 2005	FDA 483	Shelhigh, Inc. - Form 483, 2005-08-10
May, 2003	EIR	Cordis Corporation - EIR, 2003-05-19
March, 2000	FDA 483 Response	Merck, Inc. - Form 483R, 2000-04-07
August, 2002	FDA 483 Response	Ingenix Pharmaceutical Services - Form 483R, 2002-08-29
April, 2003	EIR	Boghossian, Jack MD - EIR, 2003-04-04
May, 2002	EIR	Sanofi-Aventis U.S. LLC - EIR, 2002-05-20
March, 2001	EIR	Elliot Frank Md - EIR, 2001-03-26
May, 2003	FDA 483	Cordis Corporation - Form 483, 2003-05-19
April, 2001	FDA 483	Bayshore Comm Hosp - Form 483, 2001-04-24
March, 2001	FDA 483 Response	Elliot Frank Md - Form 483R, 2001-03-26
November, 2000	FDA 483	Rubin Arnold D Md - Form 483, 2000-11-01
April, 2003	EIR	Labcorp Drug Development - EIR, 2003-04-23
April, 2003	FDA 483	Boghossian, Jack MD - Form 483, 2003-04-04
November, 2000	EIR	Rubin Arnold D Md - EIR, 2000-11-01
September, 2004	FDA 483	Diopsys, Inc. - Form 483, 2004-09-02
March, 2000	FDA 483	Merck, Inc. - Form 483, 2000-03-27

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.

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