FDA Investigator Michael F Skelly, PhD

Michael F Skelly, PhD has conducted inspections on 46 sites in 7 countries as of 13 Jan 2020. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
46
Last Inspection Date:
13 Jan 2020
Investigator Role:
FDA Investigator
Redica ID:
100008455
Countries of Inspections:
United States of America, Canada, Netherlands, Japan, South Africa, Switzerland, Germany
FDA Investigators that have inspected at least one site in common with Michael F Skelly, PhD:
Adam R Cooke, Alexandra B Pitkin, Allen F Hall, Allen Lou, Amanda E Lewin, PhD, Amanda Jones, Amber G Chung, Amber G Wardwell, Ana P Barido, Anastasia I Offordile, Andrea A Branche, Andrea D Swingle, Andrew R Wasko, Angel S Johnson, Anita R Michael, Ann Marie Karnick, Anthony A Charity, Anthony C Warchut, Anthony E Keller, RPh, Arianne L Motter, Arindam Dasgupta, PhD, Barbara A Rusin, Barbara J Holladay, Barbara J Maulfair, Barbara Janine Breithaupt, Barbara M Frazier, Benton M Ketron, Betsy C Galliher, Bill Tacket, Jr, Bonita S Chester, Brandon L Mariner, Brooke K Higgins, Byron Ho, DVM, Byungja E Marciante, Candice C Mandera, Candice J Cortes, Cara M Minelli, Carl A Anderson, Carl J Montgomery, Carla C Tuite, Carol Rivera Lopez, PhD, Carol S Sanchez, Catherine Whiteside, PhD, CDR Kimberly Y Martin, CDR Thomas R Berry, PPh, Chaltu Nwakijra, Charles A Snipes, PhD, Charles M Kerns, BLT DO, Charles R Bonapace, PhD, Charles R Cote, RIC, Chase Bourke, PhD, Chelsea W Lamm, Chris A Sack, Christian D Lynch (CDL), Christine M Whitby, CSO, Connie P Rezendes, Constance Desimone, Corey K Reno, Courtney N Long, Ct Viswanathan, PhD, Cynthia A Harris, MD, RN, Cynthia Jim, CSO, Cynthia L Evitt, Cynthia White, Dana M Klimavicz, Daniel R Azar, Darin S Wiegers, David K Glasgow, David L Chon, David M Mcnew, Dawn C Olenjack, Dawn L Wydner, Deborah B Nixon, Debra Bower, Denise L Burosh, Denise M Visco, Investigator, Devaughn Edwards, Diane Cvan Leeuwen, Dianne H Milazzo, Dina A Tallman, Donald B Mckechnie, Douglas A Campbell, Douglas W Gronski, Dr. Abhijit Raha, PhD, Dr. Gopa Biswas, PhD, Dr. Hansong Chen, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Zhou Chen (nmi), MD PhD, Dylan D Yao, MD, PhD, Elise A Murphy, Emest F Bizjak, Eric C Nielsen, Eric E Joneson, Eric M Mueller, PharmD, Eric S Pittman, Erin L Mcfiren, Erin M Mcdowell, Felix Maldonado, Gabriel Davila, Gabrielle J Swain, Gajendiran Mahadevan, PhD, Gary J Hagan, Gary T Greco, George C Amedro, George Ivan Wey, Gerald N Mcgirl, DDS, Gifford Whitehurst, Jr, Grace P Santos, Hector Jcolon Torres, Heika R Bounds, Heika R Tait, Helen B Ricalde, Himanshu Gupta, PhD, Hugh M Mcclure, II, Huixia Zhang, Iram R Hassan, PhD, Iris C Macinnes, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, James F Mccormack, PhD, James M Kewley, James M Mason, James P Stumpff, Jane E Nelson, Jane M Kreis, Janete F Guardia, Jean Blackston Hill, Jean M Kelahan, Jeffrey W Shrifter, DPM, Jessica E Hensley, Jessica L Peterson, Joanne M Schlossin, Jogy George, John A Kadavil, PhD, John J Welsh, PhD, John Kadavil, PhD, Jonathan R Campos, Jonee J Mearns, Joseph F Owens, Joseph L Despins, PhD, Joseph R Haynes, Joseph R Lambert, Joy P Matthias, Julian C Hanson, Julie D Bringger, Jyoti B Patel, PhD, Kalavati Suvarna, PhD, Kara A Scheibner, PhD, Karen L Kosar, Kassa Ayalew, MD, Kathleen B Swat, Kathryn A Krentz, Keith M Reilly, Kelly N Kerr, Kenneth Nieves, Kerun Hardeo, Krystal O Ogunremi, Kurt A Brorson, PhD, Lakisha M Williams, Larry K Austin, Lata C Mathew, PhD, Latonya M Mitchell, LCDR Chad N Thompson, LCDR Ismael Olvera, IV, LCDR Matthew R Mcnew, MPH, REHS/RS, Lenahan Lenahan, Peter R, Linda R Kuchenthal, Linda S Leja, Lisa B Orr, Lisa P Oakes, Loretta Nemchik, Lori A Gioia, Lori J Silverstein, LT Melanie M Mayor, USPHS, Luella J Rossi, Lynette P Salisbury, Marcelo O Mangalindan, Jr, Marcia A Worley, Margaret E Sarles, Margaret M Annes, Maria Pkelly Doggett, MBA, Martin J Guardia, Martin K Yau, PhD, Marya F Ricks, Mayar M Mussa, Melissa J Garcia, Melkamu Getie Kebtie, PhD, Michael G Sinkevich, Michael J Nerz, Michael P Sheehan, Michael R Klapal, Michael Serrano, Michael Skelly, Michelle D Haamid, Michelle M Noe Varga, Mike M Rashti, Mohsen Rajabi Abhari, FDA, Myra K Casey, Nancy A Bellamy, Natalie A Mickelsen, DVM, Nathaniel R Esaw, Nebil A Oumer, Nicholas C Mendiola, Nicola M Fenty Stewart, Nicole M Bell, Nilufer M Tampal, PhD, Niraj R Mehta, PhD, Norman K Starks, Pamela L Velez Vega, Patrick D Stone, MS, Patrick L Wisor, Paul Mouris, Peter R Lenahan, Philip J Snoy, Rabin N Ghoshal, Rachel C Harrington, Randy L Clarida, Richard Heath Coats, Robert D Tollefsen, Robert L Hummel, Rodney D Combs, Ronald R Ruff, Ronda Rloyd Jones, Rose Ashley, Roy R Rinc, Russ E Davis, Sam H Haidar, PhD, Samuel H Chan, PharmD, Sandra A Hughes, Scott B Laufenberg, Sean Y Kassim, PhD, Seneca D Toms, Seongeun Cho (Julia), PhD, Sherry L Secrist, BLT DO, Simone E Pitts, Sonya M Edmonds, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey A Priest, Stanley Au, Stephanie L Shapley, Stephanie Mangigian, MS/OSH, RN, Steven Eastham, Steven J Thurber, Steven P Donald, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan M Jackson, Susanna E Ford, Tamal K Chakraborti, PhD, Tamika E Allen, RN, Tawny L Colling, Terrance L Thomas, Todd J Maushart, Toyin B Oladimeji, Tracey Asinjen Wiersma, Tracy L Taras, PhD, Tyanna N Hadley, Vickie J Kanion, Viviana Matta, Vlada Matusovsky, William D Tingley, William H Linkroum, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Yih Chain Huang, PhD, Yiying E Chen, Yiyue Zhang (nmi), PhD, Young M Yoon, Yuanyuan Li, Zhongren Wu

Michael F Skelly, PhD's Documents

Publish Date Document Type Title
October, 2003 EIR Ore Pharmaceuticals Inc - EIR, 2003-10-17
July, 2003 FDA 483 Response Allied Clinical Research - Form 483R, 2003-07-22
August, 2002 EIR GlaxoSmithKline - EIR, 2002-08-02
December, 2004 FDA 483 GlaxoSmithKline - Form 483, 2004-12-01
January, 2001 EIR Schering Corporation - EIR, 2001-01-18
July, 2016 EIR ICON Development Solutions, LLC - EIR, 2016-07-22
October, 2002 FDA 483 Labcorp Early Development Laboratories, Inc. - Form 483, 2002-10-09
March, 2003 FDA 483 ICON Development Solutions, LLC - Form 483, 2003-03-14
December, 2003 FDA 483 Merck & Company, Inc. - Form 483, 2003-12-19
November, 2004 EIR Parexel Bionanalytical Services Division - EIR, 2005-01-14
June, 2001 FDA 483 Response BioReliance Corporation - Form 483R, 2001-07-05
July, 2003 EIR Allied Clinical Research - EIR, 2003-07-22
November, 2009 EIR Altasciences Preclinical Seattle, LLC - EIR, 2009-11-20
April, 2004 EIR NUVISAN GmbH - EIR, 2004-07-15
November, 2002 EIR Claude Labrie, M.D., Ph.D. - EIR, 2006-08-17
October, 2003 FDA 483 Response Ore Pharmaceuticals Inc - Form 483R, 2003-10-27
November, 2012 EIR Pra International-early Development Services - EIR, 2012-11-02
March, 2000 EIR Calvert Laboratories, Inc. - EIR, 2000-03-07
September, 2010 FDA 483 BioReliance Corporation - Form 483, 2010-09-07
March, 2010 EIR Celerion Switzerland Ag - EIR, 2010-03-13
October, 2002 FDA 483 Response Labcorp Early Development Laboratories, Inc. - Form 483R, 2002-10-30
July, 2009 FDA 483 Covance Laboratories, Inc. - Form 483, 2009-07-22
March, 2000 FDA 483 Calvert Laboratories, Inc. - Form 483, 2000-03-07
March, 2010 EIR MSD - EIR, 2010-03-05
September, 2003 EIR PPD Development, L.P. - EIR, 2003-09-12
April, 2007 FDA 483 Charles River Laboratories - Form 483, 2007-04-20
April, 2000 FDA 483 Charles River Laboratories Preclinical Services - Form 483, 2000-04-12
July, 2004 EIR PPD Development, L.P. - EIR, 2004-07-15
January, 2011 FDA 483 Pra International-early Development Services - Form 483, 2011-01-14
October, 2004 FDA 483 MDS Pharma Services - Form 483, 2004-09-21
July, 2008 FDA 483 ITR Laboratories Canada Inc. - Form 483, 2008-07-11
June, 2013 EIR Merck Sharp & Dohme - EIR, 2013-06-13
March, 2003 EIR ICON Development Solutions, LLC - EIR, 2003-03-14
November, 2004 FDA 483 Parexel Bionanalytical Services Division - Form 483, 2004-11-19
August, 2008 FDA 483 Response Altasciences Preclinical Seattle, LLC - Form 483R, 2008-10-02
December, 2017 EIR QPS, LLC - EIR, 2017-12-08
October, 2002 EIR Labcorp Early Development Laboratories, Inc. - EIR, 2002-10-09
August, 2001 FDA 483 Central Institute For Experimental Animals - Form 483, 2001-08-03
August, 2001 EIR Central Institute For Experimental Animals - EIR, 2001-09-18
June, 2001 FDA 483 BioReliance Corporation - Form 483, 2001-06-22
February, 2007 EIR COVANCE BIOANALYTICAL SERVICES, LLC - EIR, 2007-02-22
August, 2001 FDA 483 Response Central Institute For Experimental Animals - Form 483R, 2001-08-29
November, 2009 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2009-11-20
April, 2000 FDA 483 Response Charles River Laboratories Preclinical Services - Form 483R, 2000-04-17
May, 2016 EIR COVANCE BIOANALYTICAL SERVICES, LLC - EIR, 2023-11-06
August, 2008 EIR Altasciences Preclinical Seattle, LLC - EIR, 2008-08-01
September, 2005 EIR BASi Gaithersburg, LLC - EIR, 2005-09-12
April, 2007 EIR Charles River Laboratories - EIR, 2007-04-20
April, 2004 FDA 483 NUVISAN GmbH - Form 483, 2004-04-23
May, 2014 EIR Brigiette Kalsch, M.D. - EIR, 2014-05-23
October, 2004 EIR MDS Pharma Services - EIR, 2007-06-15
July, 2003 FDA 483 Piyush Patel, M.D. FRCP - Form 483, 2003-07-22
April, 2000 EIR Charles River Laboratories Preclinical Services - EIR, 2000-04-12
July, 2002 FDA 483 aaiPharma - Form 483, 2002-07-30
June, 2001 EIR BioReliance Corporation - EIR, 2001-06-22
September, 2008 FDA 483 Human Genome Sciences Inc - Form 483, 2008-09-04
December, 2003 EIR Merck & Company, Inc. - EIR, 2003-12-19
August, 2002 FDA 483 GlaxoSmithKline - Form 483, 2002-08-02
May, 2002 EIR NUVISAN GmbH - EIR, 2002-09-09
February, 2007 FDA 483 COVANCE BIOANALYTICAL SERVICES, LLC - Form 483, 2007-02-22
July, 2009 EIR Covance Laboratories, Inc. - EIR, 2009-07-22
August, 2008 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2008-08-01
October, 2003 FDA 483 Ore Pharmaceuticals Inc - Form 483, 2003-10-17

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