FDA Investigator Amy W Yan Mai

Amy W Yan Mai has inspections in 2 countries as of 13 Nov 2023. Amy W Yan Mai has collaborated with a combinined 3285 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
258
Last Inspection Date:
13 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Japan
Co-Investigator(s):
Adam J Taylor, Alia Legaux, Alice S Tsao, Althea A Williams, Amber D Brodas, Amy Constantine, Amy Kim, Amy W Mai, Ana S Cabrera, Andrew F Cohen, Andrew J Garufi, Angela Jourdain, Ann B Okon, Anthony N Onianwa, Anthony R Rauert, Arduino Frankovic, Arthur S Williams, Jr, Ashley Polizzotto, Barbara A Burke, Bernardica T Sculac Stern, Bruce G Cooper, Burnell M Henry, Camilla S Smith, Charisse K Green, Christina N Maurino, Christine M Rivera, Christopher S Fields, Colin E Tack, Dana A Razzano, Dave M Deroche, David A Laplante, David M Mcnew, David R Delucia, Deborah B Nixon, Denise L Terzian, Devon O Seymour, Diane M Gubernot, Dipesh K Shah, Donald G Gordon, Donald J Ullstrom, Dongping Dai, PhD, Donna D Gallien, MPH, Doretha M Tonkins, Douglas G Ng, Dr. Gang Wang, PhD, Dr. Robert C Horan, MD, Ellen M Landis, Emily A Walters, Emily J Schramm, Eric J Reisenauer, Erica B Raphael, Evelyn Taha, Fatima Bassa, Frank Verni, Gail L Katz, Gary J Lehr, Gayle J Gehrman, Gene D Arcy, Geoffrey B Ward, George C Amedro, George M Ibrahim, Gianine E Tompkins, Gloria E Parra, Gloria Parra, Gray, Gregson A Joseph, Haydee B Romero, Helen B Ricalde, Iram R Hassan, PhD, Irina Gaberman, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Liubicich, Jane Chen, Jennifer A Bazergui, Jennifer C Adams, Jennifer C Johnson, Jennifer L Custodio, Jennifer Macmillan, John A Iwen, John E Aghadia, Jonee J Mearns, Joseph Maselli, Joseph O Sullivan, Joshua D Lopez, Joy P Matthias, Juan Rjimenez Garcia, Judy Keihl, Juliana Falla, Kathryn A Nagy, Kellie Leveille, Kelly Doremus, Kelly I Anderson, Kenneth G Klobus, Kerun Hardeo, Kevin A Gonzalez, Kimberley A Gordon, Kimberley A Ricketts, Kimberly Y Smithson, Kwong Lee, Kwong P Lee, Kyle J Spencer, L Gnnmassimia Massimilla, PharmD, Laura M Howard, Laura Schankweiler, Laurie A Haxel, Laverne Puckett, Lawrence H Patrick, LCDR Chad N Thompson, Leena Thomas, Leeterry Moore, Linda M Sacco, Lisa Harlan, Lisa Mathew, Loretta J Miller, LTJG Matthew R Palo, Luis A Carrion, Margaret E Sarles, Marianna Sala Rhatigan, Marie Elena C Puleo, Mary Alice Papdimitriou, Mary M Finn, Meisha A Mandal, Melissa B Libby, Mercy O Quagraine, Meredith P Soehl, Investigator, Michael G Sinkevich, Michael R Dominick, Mizanne E Lewis, Mohammad Heidaran, PhD, Monika Borkowska, Mpris Inspector, Nancy L Meade, Neil J Bonzagni, PhD MPH, Nerizza B Guerin, Nicholas C Mendiola, Nicholas E Squillante, Patrick A Bowen, Patty P Kaewussdangkul, Paul E Stein, Paul Mouris, Perez, Perry T Nichols, Peter Abel, Peter M Trunk, Peter R Caparelli, Preston M Lee, Randi Lynn Bodoh, Randi Lynn Spencer, Robert J Veitch, Robert W Mcdowell Jr, Roger J Adams, Ronald Ifraimov, Russ E Davis, Samina S Khan, Sandra D Thompson, Sarah A Meehan, Sarah Forney, Sasha M Latonis, Satheesh Thomas, Shantel S Tobias, Shari L Kahn, Sherona A Ryder, Shreya Shah, Simone E Pitts, Sonia E Ortiz, Stanley Noneze, State Agency, Stephanie T Durso, Sunita Vij, Susan D Yuscius, Tammy S Notto, Tara G Bizjak, Tara K Carmody, Thomas J Mooney, Thomas P Hansen, Uduak M Inokon, Valerie A Potopsingh, Valerie C Reed, Valerie Grecek Trinh, Valerie J Grecek Trinh, Vien Q Le, Vincent T Duncan, Wayne J Meyer, Wendy M Stone, William P Chilton, Xiaokuang Lai, PhD, Young M Yoon, Yvonne C Wilkes, Yvonne M Santiago

Amy W Yan Mai's Documents

Publish Date Document Type Title
August, 2018 EIR New York Blood Center, Inc. Donor Center of NYBC - EIR, 2018-08-06
May, 2023 FDA 483 Montefiore Medical Center - Form 483, 2023-05-18
November, 2006 FDA 483 Corwood Labs Inc - Form 483, 2006-11-30
November, 2021 FDA 483 Rockefeller Fertility Center - Form 483, 2021-11-05
March, 2013 FDA 483 Mercy Medical Center - Form 483, 2013-03-11
January, 2023 FDA 483 Island Reproductive Services - Form 483, 2023-01-26
December, 2018 FDA 483 Genesis Fertility & Reproductive Medicine - Form 483, 2018-12-21
January, 2015 FDA 483 American Infertility of New York, P.C. - Form 483, 2015-01-14
September, 2022 FDA 483 The New York Fertility Center - Form 483, 2022-09-23
November, 2022 FDA 483 Neway Medical, P.C. - Form 483, 2022-11-08
August, 2009 FDA 483 New York Blood Center, Inc. - Form 483, 2009-08-13
March, 2023 FDA 483 New York Blood Center, Inc. Donor Center of NYBC - Form 483, 2023-03-30
February, 2004 EIR Sandra C. Belmont, M.D. - EIR, 2004-02-10
February, 2004 FDA 483 Sandra C. Belmont, M.D. - Form 483, 2004-02-10
December, 2006 FDA 483 Rti Donor Services, N.e. Division - Form 483, 2006-12-19
August, 2022 FDA 483 Michael A. Werner MD PC/dba M.A.Z.E Laboratories - Form 483, 2022-08-19
March, 2006 FDA 483 Rti Donor Services, N.e. Division - Form 483, 2006-03-23
March, 2013 EIR Mercy Medical Center - EIR, 2013-03-11
May, 2014 EIR IVF New York - EIR, 2023-08-16
February, 2010 EIR IVF New York - EIR, 2023-08-16
August, 2019 FDA 483 CCRM New York - Form 483, 2019-08-21
October, 2023 FDA 483 Newark Beth Israel Medical Center - Blood Bank - Form 483, 2023-10-13
January, 2024 FDA 483 Generation Next Fertility - Form 483, 2024-01-12

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