FDA Investigator Peter R Lenahan

Peter R Lenahan has conducted inspections on 370 sites in 23 countries as of 15 Jul 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:

370

Last Inspection Date:

15 Jul 2024

Investigator Role:

FDA Investigator

Redica ID:

100008619

Countries of Inspections:

United States of America, Thailand, Russian Federation, Italy, Japan, Germany, Israel, Spain, Bulgaria, Argentina, India, Colombia, Austria, Netherlands, United Kingdom of Great Britain and Northern Ireland, Jordan, Switzerland, Puerto Rico, Czechia, France, China, Turkey, Singapore

FDA Investigators that have inspected at least one site in common with Peter R Lenahan:

Addam S Reynolds, Adetutu M Gidado, Alanna L Mussawwir Bias, Alberto A Viciedo, Ali A Patino, Allen Lou, Allison E Sincek, Amatul H Marium, Amy C Amaro, Amy L Singer, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia G Lolas, Anastasia I Offordile, Andrea Siegel, PhD, Andrew J Molesky, Andrew Saunders, Angela Mock, Ann Marie Montemurro, Anna R Kwilas, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Annette Melendez, Anthony C Warchut, Anthony J Donato, Anthony M Criscuolo, Jr, Anthony N Onianwa, Anthony R Rauert, Arduino Frankovic, Ashar P Parikh, Atul J Agrawal, Barbara A Gullick, Barbara D Wright, Barbara J Holladay, Barbara J Maulfair, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Bei Yu, Brandon C Heitmeier, Brandy D Brown, Brandy N Lepage, Byungja E Marciante, Camille D Brown, Cara M Minelli, Carl A Anderson, Cary Greene, CDR Ileana Barreto Pettit, Chaoying C Ma, Charles I Ann, Charles J Chacko, Charles M Edwards, Charles M Spyr, Cheryl A Grandinetti, Cheryl J Legrand, Christina N Maurino, Christina P Burkhart, Christine M Cerenzio, Christine M Whitby, CSO, Christopher C Wilcox, Christopher Janik, Chunsheng Cai, PhD, Courtney N Long, Craig W Swanson, Cynthia A Harris, MD, RN, Cynthia E Bushee, Cynthia F Kleppinger, MD, Daniel J Grabicki, Daniel J Lahar, Daniel L Aisen, Darin S Wiegers, David H Smith, Dawn L Wydner, Deborah A Greco, Deborah B Nixon, Deborah M Mcgee, Delkis J Caycedo, Denise M Visco, Investigator, Dhaval H Patel, Diane C Thibodeau, Dien N Nguyen, Dipesh K Shah, Don A Leeseberg, Donald L Lech, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Carmelo Rosa, Dr. Gopa Biswas, PhD, Dr. Willie Wilson, PhD, Dr. Zhou Chen (nmi), MD PhD, Dung N Tran, Edmund F Mrak, Jr, Edward J Janik, Elizabeth A Laudig, Emest F Bizjak, Emily A Walters, Emmanuel A Dimaano, Jr, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Francis J Eng, Frank J Marciniak, Frederick F Razzaghi, Gabrielle J Swain, Gajendiran Mahadevan, PhD, Gavin T Cua, Gene R Gunn, George Pyramides, Gerald Mierle, Gerald T O'connor, Gianine E Delade, Gianine E Tompkins, Guerlain Ulysse, Gunther Boekhoudt, PhD, Gwyn G Dickinson, Haley H Seymour, Hang N Guo, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hugh M Mcclure, II, Israel Santiago, OCM, Jaclyn N Munsch, Jacob G Lutz, Jacqueline M Bowling, Jacqueline Mdiaz Albertini, James R Birkenstamm, James R Wormuth, Janet A Rajan, Janete F Guardia, Jay B Shah, Jean Blackston Hill, Jean M Kelahan, Jean M Mulinde, MD, Jeanne F Broderick, Jeffrey A Sincek, Jennifer C Adams, Jennifer Macmillan, Jessica S Estriplet, Joan A Loreng, Jocelyn T Ramos, Jogy George, John J Thibodeau, Jonah S Ufferfilge, Jonee J Mearns, Jorge E Martinez, Jose A Lopez, Jose Acruz Gonzalez, Jose M Cayuela, Joseph F Mcginnis, RPh, Joseph H Procopio, Jr, Josh Renzo N Ramilo, Joshua S Hoeh, Joy Rkozlowski Klena, Juanita P Versace, Julie D Bringger, Justine Tomasso, Karen E D'orazio, Kassa Ayalew, MD, Katherine E Jacobitz, Keith M Reilly, Kelli F Dobilas, Kenneth L Smalls, Kent A Conforti, Kent C Faul, Kerry A Kurdilla, Kevin D Kallander, Kim Lthomas Cruse, Kimberly A Coward, Kimberly L Schultz, Kinh Q Mac, Kip J Hanks, Kristy A Zielny, Krystal O Ogunremi, Laishan L Lam, Lata C Mathew, PhD, Laura E Garcia, Lauren Iacono Connors, PhD, Lauren L Vajo, Lawrence J Stringer, Lawrence R Johnson, LCDR Matthew J Morrison, LCDR Wilfred A Darang, Lenahan Lenahan, Peter R, Leonard Pesetsky, Li Li, Liatte Kreuger, PharmD, Linda Thai, Lisa Harlan, Lisa Mathew, Logman A Mohamed, Loretta Nemchik, Lori A Holmquist, Lori J Silverstein, Lorraine L Chavis, Luella J Rossi, Maan S Abduldayem, Madushini Dharmasena, PhD, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia D Fields, Marea K Harmon, Margaret A Foster, Margaret M Annes, Margaret M Sands, Maria Estrella, Maricelys Mercado, Marie F Morin, Marjorie D Schultz, Mark R Mcclain, Mary P Murphy, Matthew A Spataro, Matthew C Watson, Matthew R Noonan, Maxwell Van Tassell, PhD, Maya M Davis, Mayar M Mussa, Melba Trivera Clavell, Melissa B Libby, Melissa T Roy, Meredith L Sheridan, Miah Jung, Michael A Taylor, Michael C Ireland, Michael E Cimaglio, Michael F Skelly, PhD, Michael R Klapal, Michael Serrano, Michael Skelly, Michelle A Marsh, Michelle Hawkins, Michelle M Noe Varga, Michelle M Parisi, Miguel Gmanzano Maldonado, Mike M Rashti, Minerva Rogers, Minh D Phan, Mohsen Rajabi Abhari, FDA, Nancy A Bellamy, Nancy F Scheraga, Nancy L Rolli, Nealie C Newberger, Nerizza B Guerin, Nicholas A Violand, Nicola M Fenty Stewart, Nicole C Victoria, PhD, Niketa Patel, Nilufer M Tampal, PhD, Nimmy Mathews, Nina Yang, Niraj R Mehta, PhD, Normica G Facey, Omotunde O Osunsanmi, Patricia F Hughes, PhD, Paul A Licata, Paul L Bellamy, Paul Mouris, Prabhu P Raju, Rabin N Ghoshal, Rachel T Evans, Rajiv R Srivastava, Ramesh Potla, PhD, Ramon A Hernandez, Rapti D Madurawe, Raymond Liu, Raymond T Oji, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Remache, Reyes Candau Chacon, PhD, Richard J Bashay, Richard W Berning, Rita F Larocca Mahoney, Robert C Coleman, Robert E Davis, Robert G Antonsen, Jr, Robert G Ruff, Robert J Doyle, Robert J Martin, Robert Jennings, Rodney T Allnutt, Rodrigo Vilchez, Rterry Bolen, Ruben C Ayala, PharmD, Russell J Glapion, Ruth A Williams, Saleem A Akhtar, Sam H Haidar, PhD, Samantha J Pinizzotto, D V M, Sandra Kershaw, Sarah Adella Fave, Sarah L Clark, Schultz, Scott B Laufenberg, Scotty L Hargrave, Sharon K Gershon, Sharon K Thoma, PharmD, Sheri S Oliver, Sherri J Liu, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Sinai I Davis, Spiridoula Dimopoulos, Sripal R Mada, PhD, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen D Brown, Stephen J Mottola, Stephen R Souza, Steven P Donald, Susan M Halsted, Susan M Miller, Susanne M Richardson, MS RAC, Suzie L Kent, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Tawny L Colling, Theressa B Smith, Thomas E Friel, Thomas J Arista, Thomas W Garvin, Thuy T Nguyen, LCDR, Toni S Sturgis, Tonia F Bernard, Toniette K Williams, Travis E Chapman, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria M Daddeo, Victoria Spivak, Wayne E Seifert, Wayne J Meyer, William J Leonard, William Leung, William R Chang, Willy A Orantes, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Yangmin Ning, Yanming An, PhD, Yasamin Ameri, Yvesna C Blaise, Zachary A Bogorad, Zakaria I Ganiyu, Zhong Li, PhD

Peter R Lenahan's Documents

Publish Date	Document Type	Title
October, 2013	EIR	Merck Sharp & Dohme LLC - EIR, 2013-10-16
September, 2006	FDA 483	SGS North America Inc. - Form 483, 2006-09-05
January, 2019	FDA 483	Daiichi Sankyo, Inc. - Form 483, 2019-01-08
May, 2013	FDA 483	Hoffmann La Roche Inc - Form 483, 2013-05-09
December, 2015	EIR	Eisai, Inc. - EIR, 2015-12-09
December, 2019	FDA 483	Boehringer Ingelheim Pharmaceuticals, Inc. - Form 483, 2019-12-12
January, 2017	FDA 483	Novartis Pharmaceuticals Corporation - Form 483, 2017-01-24
April, 2003	EIR	Hoffmann La Roche Inc - EIR, 2003-04-30
August, 2018	EIR	Immunomedics, Inc. - EIR, 2018-08-01
December, 2019	EIR	Boehringer Ingelheim Pharmaceuticals, Inc. - EIR, 2019-12-12
May, 2008	FDA 483 Response	Schering Corporation - Form 483R, 2008-05-23
December, 2018	FDA 483 Response	Novartis Pharmaceuticals Corporation - Form 483R, 2019-01-21
December, 2015	FDA 483 Response	Eisai, Inc. - Form 483R, 2015-12-18
November, 2018	EIR	Pfizer Laboratories Div Pfizer Inc - EIR, 2018-11-02
September, 2019	FDA 483 Response	Merck Sharp & Dohme LLC - Form 483R, 2019-09-24
March, 2017	EIR	Novartis Pharmaceuticals Corporation - EIR, 2017-03-02
July, 2003	FDA 483	Forest Research Institute, Inc. - Form 483, 2003-07-28
October, 2003	FDA 483	Contract Coating Inc. - Form 483, 2003-10-10
February, 2004	FDA 483	Cordis Corporation - Form 483, 2004-03-03
June, 2003	FDA 483	Inopak Ltd - Form 483, 2003-06-16
September, 2016	FDA 483	Allergan, PLC. - Form 483, 2016-09-01
October, 2003	FDA 483 Response	Teva Pharmaceuticals USA, Inc. - Form 483R, 2003-10-16
August, 2009	FDA 483	Schering Corporation - Form 483, 2009-08-07
March, 2013	FDA 483	Bayer HealthCare Pharmaceuticals Inc. - Form 483, 2013-03-28
January, 2017	EIR	Novartis Pharmaceuticals Corporation - EIR, 2017-01-24
October, 2003	EIR	Teva Pharmaceuticals USA, Inc. - EIR, 2003-10-02
October, 2003	EIR	Contract Coating Inc. - EIR, 2003-10-10
February, 2012	FDA 483	Forest Research Institute, Inc. - Form 483, 2012-02-14
April, 2003	FDA 483 Response	Hoffmann La Roche Inc - Form 483R, 2003-05-07
March, 2013	EIR	Bayer HealthCare Pharmaceuticals Inc. - EIR, 2013-03-28
May, 2018	FDA 483	E. Jeffrey Greenberg, MD - Form 483, 2018-05-30
October, 2003	FDA 483	Teva Pharmaceuticals USA, Inc. - Form 483, 2003-10-02
July, 2013	FDA 483	AMKS TIME RELEASE LAB, LLC - Form 483, 2013-07-12
September, 2007	FDA 483	Hoffmann La Roche Inc - Form 483, 2007-09-20
May, 2003	FDA 483	SGS North America Inc. - Form 483, 2003-05-28
May, 2013	EIR	Hoffmann La Roche Inc - EIR, 2013-05-09
April, 2003	FDA 483	Hoffmann La Roche Inc - Form 483, 2003-04-30
June, 2004	FDA 483	Novartis Pharmaceuticals Corporation - Form 483, 2004-06-10
November, 2014	FDA 483 Response	Forest Research Institute, Inc. - Form 483R, 2014-12-12
May, 2005	EIR	Aphena Pharma Solutions - New Jersey, LLC - EIR, 2005-05-26
July, 2017	FDA 483	Teva API, Inc. - Form 483, 2017-07-18
March, 2009	FDA 483	Bayer HealthCare Pharmaceuticals Inc. - Form 483, 2009-03-31
September, 2019	EIR	Merck Sharp & Dohme LLC - EIR, 2019-09-06
June, 2003	EIR	Inopak Ltd - EIR, 2003-06-16
February, 2011	FDA 483	Novartis Pharmaceuticals Corporation - Form 483, 2011-02-25
October, 2013	FDA 483	Merck Sharp & Dohme LLC - Form 483, 2013-10-16
June, 2004	EIR	Novartis Pharmaceuticals Corporation - EIR, 2004-06-10
January, 2007	FDA 483	Unit Dose Solutions, Inc. of New Jersey - Form 483, 2007-01-04
January, 2021	EIR	Pfizer Inc. Groton Laboratories - EIR, 2021-01-08
September, 2019	FDA 483	Merck Sharp & Dohme LLC - Form 483, 2019-09-06
May, 2003	EIR	SGS North America Inc. - EIR, 2003-05-28
December, 2003	EIR	Merck & Co., Inc. - EIR, 2003-12-05
August, 2005	EIR	Novartis Pharmaceuticals Corporation - EIR, 2005-08-11
May, 2014	FDA 483	Frontage Clinical Services Inc. - Form 483, 2014-05-20
May, 2012	FDA 483	Merck and Company - Form 483, 2012-05-02
May, 2019	FDA 483	Colgate-Palmolive Company - Form 483, 2019-07-25
November, 2014	EIR	Forest Research Institute, Inc. - EIR, 2014-11-26
April, 2010	FDA 483	Novartis Pharmaceuticals Corporation - Form 483, 2010-04-20
February, 2018	FDA 483	Eisai, Inc. - Form 483, 2018-02-16
July, 2012	FDA 483	Suporn Chuncharunee - Form 483, 2012-07-20
January, 2020	FDA 483	Mandeep S. Oberoi, M.D. - Form 483, 2020-01-10
August, 2018	FDA 483 Response	Immunomedics, Inc. - Form 483R, 2018-11-08
May, 2011	FDA 483	Merck & Co., Inc. - Form 483, 2011-05-06
December, 2015	FDA 483	Eisai, Inc. - Form 483, 2015-12-09
July, 2015	FDA 483 Response	BioClinica Inc. - Form 483R, 2015-07-24
June, 2018	FDA 483	Srivicha Krudsood, M.D., Ph.D. - Form 483, 2018-06-28
May, 2008	FDA 483	Schering Corporation - Form 483, 2008-05-05
August, 2013	EIR	Merck Sharp & Dohme - EIR, 2013-08-16
September, 2017	EIR	Novartis Pharmaceuticals Corporation - EIR, 2017-09-07
July, 2015	EIR	BioClinica Inc. - EIR, 2015-07-24
May, 2012	EIR	Merck and Company - EIR, 2012-05-02
September, 2002	EIR	Blispak, Inc. - EIR, 2002-09-20
April, 2005	EIR	Hoffmann La Roche Inc - EIR, 2005-04-04
June, 2004	FDA 483 Response	Novartis Pharmaceuticals Corporation - Form 483R, 2004-07-02
August, 2018	FDA 483	Immunomedics, Inc. - Form 483, 2018-08-01
July, 2013	FDA 483 Response	AMKS TIME RELEASE LAB, LLC - Form 483R, 2013-07-30
October, 2018	EIR	Frontage Clinical Services Inc. - EIR, 2018-10-19
July, 2003	EIR	Forest Research Institute, Inc. - EIR, 2003-07-28
March, 2003	EIR	Everest Life Sciences LLC - EIR, 2003-03-17
December, 2018	FDA 483	Novartis Pharmaceuticals Corporation - Form 483, 2018-12-14
October, 2003	FDA 483 Response	Contract Coating Inc. - Form 483R, 2004-01-02
April, 2005	FDA 483	Hoffmann La Roche Inc - Form 483, 2005-04-04
September, 2017	EIR	Labcorp Early Development Laboratories, Inc. - EIR, 2017-09-27
July, 2013	EIR	AMKS TIME RELEASE LAB, LLC - EIR, 2013-07-12
November, 2014	FDA 483	Forest Research Institute, Inc. - Form 483, 2014-11-26
September, 2006	EIR	SGS North America Inc. - EIR, 2006-09-05
September, 2017	FDA 483	Labcorp Early Development Laboratories, Inc. - Form 483, 2017-09-27
August, 2020	EIR	Labcorp Early Development Laboratories, Inc. - EIR, 2020-08-31

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.

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