FDA Investigator Michael P Sheehan

Michael P Sheehan has conducted inspections on 175 sites in 19 countries as of 19 Sep 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
175
Last Inspection Date:
19 Sep 2019
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Spain, United States of America, Germany, Chile, Italy, Korea (Republic of), Canada, Netherlands, France, Estonia, Argentina, Brazil, Russian Federation, Poland, Sweden, Slovakia, United Kingdom of Great Britain and Northern Ireland, Switzerland, Hungary
FDA Investigators that have inspected at least one site in common with Michael P Sheehan:
Alan Escalona, Alec M O'neal, Alice C Silva, Allison C Hunter, Allison E Sincek, Amanda M Dunneback, Amber G Wardwell, Andrew J Barrowcliff, Andrew J Lang, Andrew M Kupper, Andrew T Todd, Angela E Glenn, Anna M Brannen, Annemarie Kleiza, Anthony A Charity, Arie R Dyk, Ariel Cruz Figueroa, Azza Talaat, Bailey A Uetrecht, Barbara Janine Breithaupt, Barbara M Frazier, Benjamin D Motsinger, Benjamin D Shuler, Benjamin J Dastoli, Bethany L Subel, Brenda C Hamilton, Brenda P King, Brenda S Zimmer, PhD, Brian D Rogers, Brian R Cronenwett, Brian R Yaun, Bruce H Mccullough, Bryan J Love, Bryce A Hammer, Byeongtaek Oh, Byungja E Marciante, Carlos H Ruiz, Caryn M Mcnab, Catherine J Laufmann, Charles C Conn, III, Charles M Edwards, Cheryl A Clausen, Chiaochun J Wang, Christian L Witkovskie, Christina Capacci Daniel, PhD, Christina L Bigham, Christine E Kelley, Christopher R Czajka, Christopher T Middendorf, Chryste D Best, Cody D Rickman, Constance Desimone, Courtney N Long, Craig P Seaborn, Cynthia T Cain, D Yvette Barnett, Darren S Brown, Darren S Morgan, Daryl A Dewoskin, David A Oluwo, David P Moorhead, David S Jackson, Deborah M Trout, Debra I Love, Dell S Moller, Demitria J Xiradakis, Dennis Cantellops Paite, Diane Cvan Leeuwen, Diane R Mcdaniel, Dina K West, Djamila Harouaka, Doan T Nguyen, PharmD, Don H Bark, PhD, Donald A Howell, Donna F Campbell, Dr. Carmelo Rosa, Dr. Sriram Subramaniam, PhD, Dr. Zhihao Qiu (Peter), PhD, Dyvette Arline, Edmund F Mrak, Jr, Edward D Mcdonald, Elisa A Nickum, Elizabeth B Griffin, Elizabeth Ll Edwards, Elizabeth P Kinsella, Emma A Nesbit, Erika V Butler, Erin L Mcfiren, Farhana Khan, Felipe Rde Almeida, Felix Maldonado, Frank W Perrella, Frederick M Lochner, Gajendiran Mahadevan, PhD, Gam S Zamil, Genevieve E Ghand, George M Ibrahim, Gerald B Seaborn, Jr, Gerald N Mcgirl, DDS, Gina M Brackett, Ginger M Sykes, Hang N Guo, Heather A Mccauley, Heika R Tait, Hugh M Mcclure, II, Ingrid A Zambrana, Iram R Hassan, PhD, James C Maclaughlin, James G Marsh, James M Kewley, James Norman, James P Stumpff, James R Evans, Janet L Bowen, Jason D Werne, Jason K Morgan, Javier E Santos, Javier O Vega, Javonica F Penn, Jawaid Hamid, Jazmine N Still, Jeffrey A Sincek, Jeffrey A Sommers, Jeffrey W Shrifter, DPM, Jennifer D Hollstrom, Jennifer L Gustavus, Jennifer L Jager, Jerry J Corwin, Jill R Loeliger, Jill R Raezer, Jocelyn E Massey, Joel D Hustedt, Joey V Quitania, John D Jaworski, John E Russell, Jr, John P Mistler, Jon P Antoniou, Jonathan A Ferguson, Jonathan G Matrisciano, Jorge L Guadalupe, Jose M Cayuela, Joseph X Kaufman, Joshua P Wireman, Joshua S Hunt, Juliann N Roberts, Juliann N Seward, Julie D Bringger, Justin A Boyd, Karen E D'orazio, Karen L Kosar, Karen M Cooper, Karen M Kondas, Katherine D Adams, Katherine E Jacobitz, Kathleen B Swat, Kathleen D Culver, Kathryn J Mccarty, Katie L Korchinski, Kelli L Wilkinson, Kelvin Cheung, Kenneth E Felkley, Kenneth H Williams, Kenneth M Gordon, Kevin A Gonzalez, Kevin D Kallander, Kham Phommachanh, Kim Lthomas Cruse, Krista T Ferry, Kristina J Donohue, Lata C Mathew, PhD, Laura Fontan, MS, Laureen M Geniusz, Lauren N Howard, Lauren N Smith, Lauren R Collins, Laurie A Haxel, Laurie B Frazier, LCDR Debra Emerson, LCDR Michael H Tollon, Lewis K Antwi, Linda K Cline, Lindsey M Schwierjohann, Lisa R Hilliar, Logan T Williams, Lori A Carr, Lori A Lahmann, Lourdes Valentin Aponte, Lucas B Leake, Luckner Jean Marie, Luella J Rossi, Luis Mburgos Medero, Lydia I Rosas Marty, Lynnsey A Renn, Malik S Qaiser, Mamta Gautam Basak, PhD, Maney P Sturgill, Margaret M Sands, Marian E Ramirez, Marianne Allen, Maribeth G Grattan, Maribeth G Niesen, Mark E Parmon, Mark R Mcclain, Martin K Yau, PhD, Mary B Sheets, Mary E Storch, Matt D Suedkamp, Matthew B Casale, Matthew H Pitts, Maya M Davis, Megan A Haggerty, Meredith M Cobb, Meyer J Slobotsky, Michael A Charles, Michael E Campbell, Michael E Clark, Michael F Skelly, PhD, Michael J Verdi, Michael K Larson, Michael R Goga, Michael Shanks, MS, Michele L Obert, Michele Perry Williams, Mra Davism, Mra M Barbosar, Mra Narulaa, Mra V Millarw, Nadeem I Chaudhry, Nancy A Saxenian Emmons, Nancy G Schmidt, Nancy L Neiger, Nancy L Rolli, Nicholas L Paulin, Niketa Patel, Nina Ni, Nisha C Patel, Pal S Mayasandra, Pamela A Kuist, Paraluman S Leonin, Paranthaman Senthamaraikannan, Patricia H Dlugosz, Patrick D Stone, MS, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paula A Trost, Philip F Istafanos, DMV, MS, Philip Kreiter, Phillip M Pontikos, Pifer, Qin Xu, Rafeeq A Habeeb, Ralph A Erickson, Ramon E Martinez, Rebecca Rodriguez, Regina T Brown, Renee N Easter, Richard H Penta, Richard W Berning, Robbie J Alleman, Robert D Tollefsen, Robert J Martin, Robert Jennings, Robert Rodriguez, Rosanna M Goodrich, Rose Ashley, Rose Xu, Roy C Stephens, Roy R Rinc, Saied A Asbagh, Samuel A Hamblin, Sandra A Hughes, Sarah E Mcmullen, Satheesh Thomas, Scott B Laufenberg, Scott T Ballard, Shankar L Saha, Shannon A Gregory, Simone E Pitts, Sneha S Patel, Stacey S Degarmo, Stephanie A Slater, MS, Stephanie M Mongeluzzi, Stephen J Kilker, Steve Y Rhieu, PhD, Steven C Madzo, Steven D Dittert, Steven Eastham, Steven P Eastham, Susan D Yuscius, Susan M Jackson, Susan M Taylor, Susanna E Ford, Sydney S Choi, Talmane J Fisher, Tamara M Kays, Tarun D Mehta, Tawny L Colling, Ted L Anderson, Teresa K Kastner, Terrance L Thomas, Thai T Duong, Thomas C Woods, Thomas J Arista, Thomas J Prigge, Thomas W Nojek, Thunder N Dunkijacobs, Tiara Nbrown Crosen, Tiffny N Cannon, Torrance J Slayton, Tracey L Harris, Travis V Hull, Troy A Huffman, Tyra S Wisecup, Ucheabuchi Cchudi Nwankwor, Uttaniti Limchumroon (Tom), Vidya B Pai, Vipulchandra N Dholakia, Wayne D Mcgrath, Wen Ning Chan (Sally), Ying Zhang, Yumi J Hiramine, Yvette Mlacour Davis, Zhigang Sun, PhD

Michael P Sheehan's Documents

Publish Date Document Type Title
May, 2000 EIR NUVISAN GmbH - EIR, 2000-12-06
March, 2004 EIR Hill Top Research Inc - EIR, 2004-03-26
December, 2010 FDA 483 Allergan Sales, LLC - Form 483, 2010-12-03
December, 2011 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2011-12-02
September, 2004 FDA 483 Hill Top Research Inc - Form 483, 2004-09-23
January, 2015 EIR GP PHARM SA - EIR, 2015-01-27
February, 2013 FDA 483 Response Catalent Pharma Solutions, LLC - Form 483R, 2013-02-26
February, 2013 EIR Catalent Pharma Solutions, LLC - EIR, 2013-02-05
October, 2000 FDA 483 Allergan Sales, LLC - Form 483, 2000-10-11
November, 2012 FDA 483 Allergan Sales, LLC - Form 483, 2012-11-05
March, 2013 EIR Ben Venue Laboratories Inc. - EIR, 2013-03-29
March, 2000 FDA 483 William E Evans MD - Form 483, 2000-03-02
July, 2002 FDA 483 Forrest Enterprises Inc - Form 483, 2002-07-26
March, 2014 FDA 483 Nelson Watts M.D. - Form 483, 2014-03-18
May, 2013 EIR Patheon Pharmaceuticals Inc. - EIR, 2013-05-13
January, 2001 EIR Adare Pharmaceuticals, Inc. - EIR, 2001-01-08
March, 2017 FDA 483 Spoonamore Drug Co Inc - Form 483, 2017-03-14
March, 2000 FDA 483 Response William E Evans MD - Form 483R, 2000-03-08
May, 2000 FDA 483 NUVISAN GmbH - Form 483, 2000-05-12
March, 2011 FDA 483 Patheon Pharmaceuticals Inc. - Form 483, 2011-03-24
May, 2001 EIR Martin B Scharf PhD - EIR, 2001-05-11
May, 2011 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2011-05-25
July, 2019 FDA 483 Cosmelab Co Ltd - Form 483, 2019-07-17
September, 2015 FDA 483 Vann Healthcare Services Inc - Form 483, 2015-09-30
March, 2002 FDA 483 Smithfield BioScience, Inc. - Form 483, 2002-03-13
December, 2010 EIR Allergan Sales, LLC - EIR, 2010-12-03
February, 2000 EIR Catalent Pharma Solutions, LLC - EIR, 2000-02-18
June, 2012 EIR Teva Women's Health LLC - EIR, 2012-06-04
June, 2012 FDA 483 Teva Women's Health LLC - Form 483, 2012-06-04
January, 2001 FDA 483 Adare Pharmaceuticals, Inc. - Form 483, 2001-01-08
April, 2002 EIR Martin B Scharf PhD - EIR, 2002-04-26
July, 2009 FDA 483 Teva Women's Health LLC - Form 483, 2009-07-01
September, 2009 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2009-09-17
October, 2016 FDA 483 Avantor Performance Materials, LLC - Form 483, 2016-10-24
February, 2013 FDA 483 Catalent Pharma Solutions, LLC - Form 483, 2013-02-05
August, 2012 FDA 483 Avantor Performance Materials, LLC - Form 483, 2012-08-17
April, 2017 EIR Procter & Gamble Co - EIR, 2017-04-06
February, 2001 FDA 483 Martin B Scharf PhD - Form 483, 2001-02-23
November, 2011 FDA 483 Alkermes, Inc - Form 483, 2011-11-04
February, 2000 FDA 483 Catalent Pharma Solutions, LLC - Form 483, 2000-02-18
March, 2002 FDA 483 Response Smithfield BioScience, Inc. - Form 483R, 2002-03-27
September, 2001 FDA 483 Orchem Corporation - Form 483, 2001-09-21
October, 2016 EIR Avantor Performance Materials, LLC - EIR, 2016-10-24
September, 2004 FDA 483 Maria Stein Grain - Form 483, 2004-09-14
February, 2001 EIR Martin B Scharf PhD - EIR, 2001-02-23
November, 2012 EIR Allergan Sales, LLC - EIR, 2012-11-05
August, 2012 EIR Avantor Performance Materials, LLC - EIR, 2012-08-17
March, 2003 FDA 483 Smithfield BioScience, Inc. - Form 483, 2003-03-18
March, 2017 EIR Spoonamore Drug Co Inc - EIR, 2017-03-14
March, 2000 EIR William E Evans MD - EIR, 2000-03-02
January, 2010 FDA 483 Prof. Anna Dmoszynska, MD - Form 483, 2010-01-15
January, 2016 FDA 483 Central Admixture Pharmacy Services Inc - Form 483, 2016-01-21
January, 2015 EIR BCN Peptides SA - EIR, 2015-01-16
October, 2018 FDA 483 TMC Acquisitions LLC dba Tailor Made Compounding - Form 483, 2018-10-24
April, 2016 FDA 483 Wickliffe Pharmaceutical Inc - Form 483, 2016-04-07
May, 2009 FDA 483 Ben Venue Laboratories Inc. - Form 483, 2009-05-13
January, 2009 EIR QPS Netherlands B.V. - EIR, 2009-01-23
July, 2016 EIR Teva Women's Health LLC - EIR, 2016-07-15
May, 2013 FDA 483 Patheon Pharmaceuticals Inc. - Form 483, 2013-05-13
March, 2003 EIR Smithfield BioScience, Inc. - EIR, 2003-03-18

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.

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