FDA Investigator Marion Michaelis

Marion Michaelis has inspections in 15 countries as of 09 Nov 2023. Marion Michaelis has collaborated with a combinined 6140 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
31
Last Inspection Date:
09 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
Croatia, France, United States of America, Belgium, Israel, Japan, Germany, Italy, Canada, Austria, India, China, United Kingdom of Great Britain and Northern Ireland, Slovenia
Co-Investigator(s):
A Williams, Adam R Cooke, Aditi S Thakur, Aimee Cunningham, PhD, Alexey Khrenov, PhD, Alicia M Mozzachio, Amy A Johnson, Amy Johnson, Ana S Cabrera, Andrea Franco, Angela E Glenn, Angela K Shen, Anissa M Cheung, Anita R Michael, Anjali Shukla, PhD, Ann Marie Montemurro, Ann Marie Schofield, Annemarie Bodnar, Annet R Rajan, Annette A Ragosta, Anthony F Lorenzo, Anthony W Lee, Arie C Menachem, Arsen Karapetyan, Azza Talaat, Barbara T Carmichael, Bo Chi, PhD, Bonita S Chester, Brentley S Collins, Brian D Nicholson, Brooke K Higgins, Brooke K Secman, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Cameron J Smith, Carla J Lundi, Carole L Jones, Caryn M Mcnab, Cassandra Overking, Catherine J Laufmann, CDR Donald Ertel, CDR Thomas R Berry, PPh, Chad R Burger, Charles M Edwards, Cheryl A Clausen, Christian D Lynch (CDL), Christina H Owens, Christina V Santos, Christine A Harman, PhD, Christine W Twohy, Christopher D Leach, Christopher T Middendorf, Christopher T Peters, Concepcion Cruz, Jr, Craig D Zagata, Creighton T Tuzon, Cynthia Jim, CSO, Cynthia Kelley, David S Cho, PhD, Dawn L Wydner, Deborah Schmiel, PhD, Dell S Moller, Dennis Cantellops Paite, Derek C Price, Derek S Smith, PhD, Destry M Sillivan, Devaughn Edwards, Diane L Raccasi, Diane T Bargo, Diane T O'bien, Diane T O'brien, Dino Feigelstock (DF), PhD, Dmitriy V Volokhov, PhD, Dogbeda F Mackenzie, Donald C Obenhuber, PhD, Douglas A Campbell, Dr. Barbara D Paul, PhD, Dr. Gang Wang, PhD, Dr. Ralph M Bernstein, PhD, Dr. Willie F Vann, PhD, Dwayne E Dollins, Edmund F Mrak, Jr, Edmund Fmrakjr S, Edwin Melendez, Eliezar Ramos, Ellen Huang, Emest F Bizjak, Emmanuel A Dimaano, Jr, Ephrem Hunde, PhD, Erika V Butler, Eural E Porter, Felix Maldonado, Fulton A Varner, Garrad R Poole, Gene D Arcy, Genoula K Ryan, Gerald B Seaborn, Jr, Gerald D Bromley, Jr, Gilbert T Salud, Ginger M Sykes, Grace Deneke, Hai Lien T Phung, Helen B Ricalde, Helen R Bester, Holly M Scott, Hongna Wang, Howard Anderson, PhD, Hyung Yul Lee, Ibad U Khan, J David Doleski, Jacek Cieslak, PhD, Jacqueline Mdiaz Albertini, James C Maclaughlin, James E Keller, PhD, James M Mason, James R Evans, James W Leonette, Jamie L Dion, Janet A Rajan, Jason F Chancey, Jean M Kelahan, Jeffrey P Raimondi, Jennifer A Baker, Jennifer L Schmidt, Jennifer M Gogley, Jennifer Macmillan, Jeremy W Rotton, Jessica Hankins, PhD, Jie He, Joan A Loreng, Joanne Pryzbylik, John D Finkbohner, PhD, John F Cipollo, John M Mcinnis, Jonathan W Chapman, Jose Acruz Gonzalez, Jose O Hernandez, Jose Ohernandez Guzman, Jose Velez, Joseph F Owens, Joseph George, Joseph Kutze, PhD, Joyce A Rockwell, Juandria V Williams, Julianne C Mccullough, Julie D Bringger, Justin A Boyd, Karen A Coleman, Kathleen M Jordan, Kelly D Moore, Kelly I Anderson, Kelly L Anderson, Kenneth Nieves, Kevin A Gonzalez, Kevin P Foley, Kimberly M Bigler, Kirsten L Vadheim, PhD, Kirsten L Vodheim, PhD, Lakshmi Narasimhan, PhD, Laura Fontan, MS, Laura I Salazar, PhD, Laurel A Beer, Laurie Nelson, Laurie P Norwood, LCDR Debra Emerson, LCDR Randall L Morris, Lei Zhang, PhD, Leslie D Wagner, Lewis K Antwi, Linda F Murphy, Linda M Cheny, Linda R Kuchenthal, Linda Thai, Lindsey Brown, PhD, Lisa M Parsons, Lois K Gross, Lori S Lawless, Lucila B Nwatu, Lydia S Chan, Madelyn Renteria, Madushini Dharmasena, PhD, Malgorzata G Norton, Malini Wileman, PhD, Marc A Jackson, Jr, Margarita Santiago, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Marion Michaelia, Mariza M Jafary, Marjorie A Shapiro, PhD, Mark A Elengold, Martha T Olone, Mary Alice Papdimitriou, Mary T Carden, Maryam Tabatabaie, Matthew B Casale, Maxwell Van Tassell, PhD, Megan A Haggerty, Meihong Liu, Mekonnen Lemma Dechassa, PhD, Melissa J Garcia, Mercy O Quagraine, Merideth K Rose, Michael A Charles, Michael E Maselli, Michael J Vardon, Michael Shanks, MS, Michele Dougherty, PhD, Michele L Forster, PhD, Michele Perry Williams, Mihaly S Ligmond, Mizanne E Lewis, Mohammad Heidaran, PhD, Monica Commerford, PhD, Monica Markovski, PhD, Monika Borkowska, Mra B Kamberem, Mra Davism, Mra Munizn, Nancy G Schmidt, Nawab A Siddiqui, Nebil A Oumer, Nicholas A Violand, Nicholas L Hunt, Nicholas M Smith, Nicholas Obiri, PhD, Nicole K Trudel, Nikisha M Bolden, Noreen Muniz, Omatunde O Osunsamni, Omotunde O Osunsanmi, Pankaj H Amin, Parul M Patel, Patricia D Stahnke, Patricia F Hudson, Patricia Fhughes Troost, Patrick C Klotzbuecher, Patrick J Lynch, Paul A Bonneau, Paul L Bellamy, Paul W Moy, Paula A Trost, Paula M Laplant, Peter Adams, PhD, Phillip Angart, PhD, Prabhu P Raju, Pratik S Upadhyay, DDC, Priscilla M Pastrana, Qiao Y Bobo, Quyen T Tran, Rachel C Harrington, Ramesh Potla, PhD, Ramon E Martinez, Rebecca K Olin, Rebecca Rodriguez, Regina Gibson Melton, Regina T Brown, Reyes Candau Chacon, PhD, Richard D Manney, Richard W Thornton, Riley C Myers, PhD, Robert C Coleman, Robert D Tollefsen, Robert J Martin, Robert Sausville, Robert W Jennings, Robin Levis, PhD, Roger F Zabinski, Ronald Ifraimov, Rose Ashley, Rose M Ashley, Roy C Stephens, Russell J Glapion, Saied A Asbagh, Sandra A Hughes, Sarah Arden, Sarah B Tanksley, Sarah E Rhoades, Sarah Forney, Sarah Kennett, PhD, Satheesh Thomas, Scott R Nichols, PhD, Scott T Ballard, Sena G Dissmeyer, Seneca D Toms, Sharon K Pederson, Sharon K Thoma, PharmD, Sheryl A Kochman, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Solomon Yimam (SY), Stephen D Brown, Steven A Rubin, Steven B Hertz, Steven E Bowen, PhD, Steven Fong, MS, PhD, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susan Yu, Susant Hadman, Tamara M Casselman, Teresita C Mercado, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tina S Roecklein, Tonia F Bernard, Toyin B Oladimeji, Unnee Ranjan, Uttaniti Limchumroon (Tom), Valerie J Grecek Trinh, Virginia Carroll, PhD, Viviana Matta, Walter Fava, Walter L Fava, Wayne E Seifert, Wei Wang, PhD, Wendy G Tan, PhD, Wendy Tam, William A Warnick, William H Linkroum, William Hallett, PhD, Xiaokuang Lai, PhD, Xiaoping Guan, Ying Xin Fan, PhD, Yumi J Hiramine, Yun Wu, PhD, Zedong Dong, Zhao Wang, PhD, Zhihao Qiu (Peter), PhD, Zhong Li, PhD, Zhongren Wu

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

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