FDA Investigator Peter R Lenahan

Peter R Lenahan has inspections in 22 countries as of 13 Oct 2023. Peter R Lenahan has collaborated with a combinined 6625 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
370
Last Inspection Date:
13 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Colombia, Germany, Israel, Japan, Bulgaria, United Kingdom of Great Britain and Northern Ireland, Singapore, Italy, Argentina, Czechia, Russian Federation, Switzerland, Austria, Netherlands, Jordan, India, Spain, Turkey, Thailand, China, France
Co-Investigator(s):
Abthony C Warchut, Addam S Reynolds, Adetutu M Gidado, Alanna Lmussawwir 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 Kevilag, Anna Kwilas, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Annette Melendez, Anthony C Warchut, Anthony J Donato, Anthony M Criscuolo, Jr, Anthony N Onianwa, 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, Byunja 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 Smith, 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, Douglas Florentino, Dr. Carmelo Rosa, Dr. Gopa Biswas, PhD, Dr. Zhou Chen (nmi), MD PhD, Dung N Tran, E Marciante, Edmund F Mrak, Jr, Edward J Janik, Elizabeth A Laudig, Emest F Bizjak, Emily A Walters, Emmanuel A Dimaano, Jr, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Francis J Eng, Frank J Marciniak, Frederick 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 J Colon Torres, Helen B Ricalde, Helen Verdel, Herrmann, 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, 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 Cruz, Jose Acruz Gonzalez, Jose Alopez Rubet, Jose M Cayuela, Joseph F Mcginnis, RPh, Joseph H Procopio, Josh Renzon 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, King, Kinh Q Mac, Kinh Qouc 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, Liattle Krueger, Linda Thai, Lisa Harlan, Lisa Mathew, Logman A Mohamed, Loretta Nemchik, Lori A Holmquist, Lori J Silverstein, Lorraine L Chavis, Luella J Rossi, M Patriciaurphy Murphy, 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 T Rivera, 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, Michelle M Parisi, Miguel G Manzano, Mike M Rashti, Minerva Rogers, Minh D Phan, Mohsen Rajabi Abhari, FDA, Mpris Inspector, 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 Tampal, PhD, Nimmy Mathews, Nina Yang, Niraj Mehta, Normica G Facey, Omotunde O Osunsanmi, Patricia Fhughes Troost, 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 W Jennings, Rodney T Allnutt, 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 Davis, Sinai I Davis, Spiridoula Dimopoulos, Sripal R Mada, PhD, State Agency, 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, MSc RAC ELS, Suzie L Kent, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Tawny L Colling, 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, Tynna 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, Willie Wilson, 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
July, 2015 EIR BioClinica Inc. - EIR, 2015-07-24
October, 2003 FDA 483 Response Teva Pharmaceuticals USA, Inc. - Form 483R, 2003-10-16
April, 2003 FDA 483 Hoffmann La Roche Inc - Form 483, 2003-04-30
March, 2013 EIR Bayer HealthCare Pharmaceuticals Inc. - EIR, 2013-03-28
June, 2018 FDA 483 Srivicha Krudsood, M.D., Ph.D. - Form 483, 2018-06-28
July, 2015 FDA 483 Response BioClinica Inc. - Form 483R, 2015-07-24
February, 2018 FDA 483 Eisai, Inc. - Form 483, 2018-02-16
September, 2002 EIR Blispak, Inc. - EIR, 2002-09-20
January, 2017 EIR Novartis Pharmaceuticals Corporation - EIR, 2017-01-24
April, 2010 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2010-04-20
May, 2012 EIR Merck and Company - EIR, 2012-05-02
July, 2013 EIR AMKS TIME RELEASE LAB, LLC - EIR, 2013-07-12
August, 2018 FDA 483 Immunomedics, Inc. - Form 483, 2018-08-01
May, 2011 FDA 483 Merck & Co., Inc. - Form 483, 2011-05-06
January, 2020 FDA 483 Mandeep S. Oberoi, M.D. - Form 483, 2020-01-10
July, 2012 FDA 483 Suporn Chuncharunee - Form 483, 2012-07-20
November, 2014 EIR Forest Research Institute, Inc. - EIR, 2014-11-26
November, 2014 FDA 483 Forest Research Institute, Inc. - Form 483, 2014-11-26
September, 2006 EIR SGS North America Inc. - EIR, 2006-09-05
April, 2005 FDA 483 Hoffmann La Roche Inc - Form 483, 2005-04-04
July, 2003 EIR Forest Research Institute, Inc. - EIR, 2003-07-28
June, 2004 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2004-06-10
December, 2015 FDA 483 Eisai, Inc. - Form 483, 2015-12-09
October, 2003 FDA 483 Teva Pharmaceuticals USA, Inc. - Form 483, 2003-10-02
May, 2018 FDA 483 E. Jeffrey Greenberg, MD - Form 483, 2018-05-30
November, 2014 FDA 483 Response Forest Research Institute, Inc. - Form 483R, 2014-12-12
May, 2003 FDA 483 SGS North America Inc. - Form 483, 2003-05-28
January, 2007 FDA 483 Unit Dose Solutions, Inc. of New Jersey - Form 483, 2007-01-04
September, 2019 FDA 483 Response Merck Sharp & Dohme LLC - Form 483R, 2019-09-24
December, 2015 EIR Eisai, Inc. - EIR, 2015-12-09
October, 2003 FDA 483 Contract Coating Inc. - Form 483, 2003-10-10
April, 2003 EIR Hoffmann La Roche Inc - EIR, 2003-04-30
August, 2018 EIR Immunomedics, Inc. - EIR, 2018-08-01
May, 2013 EIR Hoffmann La Roche Inc - EIR, 2013-05-09
March, 2009 FDA 483 Bayer HealthCare Pharmaceuticals Inc. - Form 483, 2009-03-31
July, 2013 FDA 483 AMKS TIME RELEASE LAB, LLC - Form 483, 2013-07-12
May, 2005 EIR Aphena Pharma Solutions - New Jersey, LLC - EIR, 2005-05-26
December, 2015 FDA 483 Response Eisai, Inc. - Form 483R, 2015-12-18
August, 2013 EIR Merck Sharp & Dohme - EIR, 2013-08-16
December, 2003 EIR Merck & Co., Inc. - EIR, 2003-12-05
September, 2017 EIR Novartis Pharmaceuticals Corporation - EIR, 2017-09-07
August, 2009 FDA 483 Schering Corporation - Form 483, 2009-08-07
October, 2013 EIR Merck Sharp & Dohme LLC - EIR, 2013-10-16
September, 2016 FDA 483 Allergan, PLC. - Form 483, 2016-09-01
September, 2019 EIR Merck Sharp & Dohme LLC - EIR, 2019-09-06
February, 2012 FDA 483 Forest Research Institute, Inc. - Form 483, 2012-02-14
October, 2003 EIR Contract Coating Inc. - EIR, 2003-10-10
November, 2018 EIR Pfizer Laboratories Div Pfizer Inc - EIR, 2018-11-02
February, 2011 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2011-02-25
October, 2003 FDA 483 Response Contract Coating Inc. - Form 483R, 2004-01-02
March, 2003 EIR Everest Life Sciences LLC - EIR, 2003-03-17
May, 2008 FDA 483 Schering Corporation - Form 483, 2008-05-05
May, 2008 FDA 483 Response Schering Corporation - Form 483R, 2008-05-23
December, 2019 EIR Boehringer Ingelheim Pharmaceuticals, Inc. - EIR, 2019-12-12
September, 2019 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2019-09-06
September, 2007 FDA 483 Hoffmann La Roche Inc - Form 483, 2007-09-20
September, 2006 FDA 483 SGS North America Inc. - Form 483, 2006-09-05
March, 2013 FDA 483 Bayer HealthCare Pharmaceuticals Inc. - Form 483, 2013-03-28
January, 2021 EIR Pfizer Inc. Groton Laboratories - EIR, 2021-01-08
October, 2003 EIR Teva Pharmaceuticals USA, Inc. - EIR, 2003-10-02
October, 2018 EIR Frontage Clinical Services Inc. - EIR, 2018-10-19
June, 2004 EIR Novartis Pharmaceuticals Corporation - EIR, 2004-06-10
June, 2003 FDA 483 Inopak Ltd - Form 483, 2003-06-16
September, 2017 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2017-09-27
October, 2013 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2013-10-16
July, 2013 FDA 483 Response AMKS TIME RELEASE LAB, LLC - Form 483R, 2013-07-30
August, 2005 EIR Novartis Pharmaceuticals Corporation - EIR, 2005-08-11
September, 2017 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2017-09-27
August, 2018 FDA 483 Response Immunomedics, Inc. - Form 483R, 2018-11-08
May, 2012 FDA 483 Merck and Company - Form 483, 2012-05-02
May, 2014 FDA 483 Frontage Clinical Services Inc. - Form 483, 2014-05-20
December, 2018 FDA 483 Response Novartis Pharmaceuticals Corporation - Form 483R, 2019-01-21
January, 2017 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2017-01-24
May, 2003 EIR SGS North America Inc. - EIR, 2003-05-28
May, 2013 FDA 483 Hoffmann La Roche Inc - Form 483, 2013-05-09
April, 2005 EIR Hoffmann La Roche Inc - EIR, 2005-04-04
December, 2019 FDA 483 Boehringer Ingelheim Pharmaceuticals, Inc. - Form 483, 2019-12-12
June, 2004 FDA 483 Response Novartis Pharmaceuticals Corporation - Form 483R, 2004-07-02
June, 2003 EIR Inopak Ltd - EIR, 2003-06-16
December, 2018 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2018-12-14
March, 2017 EIR Novartis Pharmaceuticals Corporation - EIR, 2017-03-02
January, 2019 FDA 483 Daiichi Sankyo, Inc. - Form 483, 2019-01-08
July, 2003 FDA 483 Forest Research Institute, Inc. - Form 483, 2003-07-28
February, 2004 FDA 483 Cordis Corporation - Form 483, 2004-03-03
April, 2003 FDA 483 Response Hoffmann La Roche Inc - Form 483R, 2003-05-07
August, 2020 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2023-09-20
July, 2017 FDA 483 Teva API, Inc. - Form 483, 2017-07-18
May, 2019 FDA 483 Colgate-Palmolive Company - Form 483, 2019-07-25

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