FDA Investigator Alexander M Kay

Alexander M Kay has inspections in 9 countries as of 15 Nov 2023. Alexander M Kay has collaborated with a combinined 5226 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
382
Last Inspection Date:
15 Nov 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, India, Thailand, Ecuador, Dominican Republic, China, Poland, Bulgaria, Russian Federation
Co-Investigator(s):
Abby M Miller, Adamsr, Alexandra B Pitkin, Alicia A Borg Borm, Amber M Howell, Andrea A Branche, Andrew K Haack, PhD, Anita Narula, PhD, Armando Chavez, MS, Ashar P Parikh, Ashleigh P Barkans, Astrida B Mattson, Ava M Bowman, Avery J Dennis, Barbara D Wright, Barbara J Rincon, Barbara Janine Breithaupt, Barbara T Carmichael, Belinda E Clifton, Benjamin W Anderson, Billi Jom Johnson, Blake R Jensen, Bowman, Bradley Dworak, PhD, Brenda L Reihing, Brent W Higgs, Brentley S Collins, Brian E Thompson, Brittany R Laymon, Bruce R Burrell, Bryan Baker, Bryan J Love, Bryce A May, Bush, Carl A Anderson, Carol F Robinson, Carolyn J Cook, Carr Sharpe, Caryn M Mcnab, Cassandra L Winters, Ce'nedra M Martin, Celena Ngo, Celeta S Coves, Celia L Hutchinstein, Celia L Silverstein, Chorng M Cheng, Christian D Lynch (CDL), Christina L Norton, Christine A Harman, PhD, Christopher S Genther, Christopher T Middendorf, Clinton R Vanblaricom, Connie P Rezendes, Connie P Rezenes, Courtney N Long, Craig T Rybus, Creighton T Tuzon, Crystal A Harlan, Cynthia J Lee, MS, Cynthia L Gorveatt, Dan G Eisenbrey, Daniel L Aisen, Daniel W Cline, David Serrano, David Y Hernandez, Dawn E Barkans, Deborah A Nebenzahl, Debra J Fracassa, Dellarese L Herbert, Denise L Burosh, Dennis G Kawabata, Dennis R Hudson, Devon M Shoop, Dewey W Darold, Dianna D Wardlow Dotter, Dirk L Lincoln, Dolores E Price, Don H Bark, PhD, Donald W Jehn, Edward D Harris, Edward J Janik, Edwin Melendez, Eileen A Liu, Elizabeth E Hart (ASCP), MT, Elizabeth S Howell, Elmina E Akwo, Emal Wahab, Emily B Camire, Eric T Huebler, Erica R Mahone, Erin L Nagel, Garrad R Poole, Gene D Arcy, Gene R Gunn, Gerard Pde Leon, Gina C Collins, Gloria A Milster, Gloria J Baca, MS, Graham N Giesen, Hanna L Potter, Harmon M Blanch, Hasan A Irier, PhD, Heika R Bounds, Heika R Tait, Herminio C Francisco, Hugh Grimoldby, Hung V Le, Ismael Olvera, IV, Jack L Christy, Jacqueline Mdiaz Albertini, James C Henry, James D Eildreth, James D Hildreth, James I Vik, James P Stallings, Jane M Kreis, Jason T Lovelady, Jean Brewer, Jeannine K Wooten, Jeff A Gard, Jeff M Uriarte, Jeffrey D Varelman, Jeffrey J Leclair, Jennifer A Baker, Jennifer L Bridgewater, Jennifer L Jager, Jennifer L Sheehan, Jessica B Clark, Jessica L Walters Moell, Jessie E Morris, Jinnie Kokiatkulkij, Joey V Quitania, John A Daubenspeck, John A Iwen, John E Emmert, Jonathan T Little, Jose O Caraballo Rivera, Joseph C Yen, Juanita Banuelos, Judy C Nepsa, Julian C Hanson, Ka L Wong, Kaarin M Slotte, Karen J Bak, Karen M Cooper, Kari M Johansen, Kate L Allen, Kathryn A Krentz, Kay, Kellie L Westerbuhr, Kelly D Moore, Kelsey A Hustedt, Kelsey M Bishop, Kenneth O Gee, PhD, Kevin T Gerrity, Kham Phommachanh, Kimberly A Dux, Kimberly Lewandowski Walker, Kimberly M Lichter, Kip J Hanks, Kirtida Patel, Kristin M Abaonza, Kurt M Hafer, Laura E Garcia, Laura E Hausch, Laura Kathryn, Laurel A Beer, Lauren E Swantko, Laurissa S Flowers, LCDR Debra Emerson, Leena Thomas, Leeterry Moore, Leslie W Gilbert, Lester O Boian, Leya A Grosch, Lilly O Barton, Lisa K Capron, Lisa M Althar, Lori A Gioia, Lori J Silverstein, Lorna F Jones, LTJG Bradley E Benasutti, Lucas B Leake, Lynda L Perry, PhD, Mai Hang, Marc A Jackson, Jr, Marco A Solorio, Margo C Jones, Margo Cl Jones, Maria Pkelly Doggett, MBA, Marianne Allen, Marijo B Kambere, PhD, Marion W Nadeau, Mariza M Jafary, Mark C Saale, Mark E Imsland, Mark E Moen, Mark W Babbitt, Marlene L Davis, Marsha L Mccauley, Mary Ewilkerson Brinsko, Maxine H Wong, Michael J Schibi, Michael S Hudson, Mihaly S Ligmond, Mikel T Wright, Mohsen Rajabi Abhari, FDA, Monica R Maxwell, Mpris Inspector, Nancy A Saxenian Emmons, Nancy E Doyle, Naveen B Walker, Neil J Traaen, Nianna C Burns, Nichole A Broadhacker, Nicola M Fenty Stewart, Nicole M Bell, Omotunde O Osunsanmi, Ounchith J Phabmixay, Paul F Rader, Paul M Chefor, Paula A Trost, Paula J Wilkerson, Peter Kessler, PhD, Peter T Regan, Philippe A Cornet, Phillip J Sample, Prabhu P Raju, Rachelle M Deskins, Randy L Self, Raymond W Brullo, Rebecca Rodriguez, Rebecca T Davis, Richard G Runyon, Richard Heath Coats, Richard J Bashay, Richard T Riggie, Richard W Tubb, Richmond K Yip, Robert B Shibuya, MD, Robert C Hoover, Robert D Tollefsen, Robert J Vezzetti, Robert S Sweeton, Rocco C Black, Roger F Zabinski, Ruben C Ayala, PharmD, S Lori Brown, PhD MPH, Sangeeta M Khurana, PhD, Sangeeta M Rataul, Sarah A Palmer, Sarah J Cullen, Savini, Scott A Nabe, Scott B Laufenberg, Scott Reynolds, Sean P Desbrow, Shannon J Hall, Shelagh D Schopen, Shelley H Beausoleil, Sherri N Rohlf, MD, Sonia R Peterson, State Agency, Stephanie E Hubbard, Stephen R Souza, Sundy Ven, Sunitha K Rajaram, PhD, Susan F Laska, MS, Susan M Miller, Tara A Marshall, Tawny L Colling, Terri L Dodds, Terry L Dodds, Thao T Kwan, Thea C Grome, Theressa B Smith, Thomas J Arista, Thunder N Dunkijacobs, Timothy C Grome, Timothy D Evans, Timothy S Williamson, Tina S Roecklein, Tracy K Li, Travis S Bradley, Trushani T Desai, Uttaniti Limchumroon (Tom), Vanessa Y Gelsey, PhD, Vanessa Y Jacobs, Victoria V Bot, Wayne F Larson, Willis L Hicks, Xiomara Copeland, Young M Choi, PhD, Young M Yoon, Yvette Mlacour Davis, Yvonne C Wilkes, Zachary P Wachlarowicz

Alexander M Kay's Documents

Publish Date Document Type Title
July, 2003 EIR BioLife Plasma Services, L.P. - EIR, 2003-07-25
December, 2010 FDA 483 Jubilant HollisterStier LLC - Form 483, 2010-12-15
July, 2003 EIR Biomat USA, Inc. - EIR, 2003-07-10
July, 2012 EIR Xtant Medical Holdings Inc - EIR, 2012-07-26
October, 2003 FDA 483 The American National Red Cross - Form 483, 2003-10-20
October, 2014 EIR Bloodworks - EIR, 2014-10-15
December, 2003 EIR Biomat USA, Inc. - EIR, 2003-12-04
October, 2002 FDA 483 Pasco Corporation of America - Form 483, 2002-10-11
April, 2009 EIR James W. Baker, MD Clinical Investigator - EIR, 2009-04-14
May, 2015 EIR Jinming Liu - EIR, 2015-05-08
April, 2009 FDA 483 James W. Baker, MD Clinical Investigator - Form 483, 2009-04-14
September, 2003 EIR Bloodworks - EIR, 2003-09-12
April, 2015 EIR Institutional Review Board of Billings Inc - EIR, 2015-04-02
April, 2009 FDA 483 Response James W. Baker, MD Clinical Investigator - Form 483R, 2009-05-29
April, 2015 FDA 483 Institutional Review Board of Billings Inc - Form 483, 2015-04-02
June, 2002 EIR Noonan, Michael J Md - EIR, 2002-06-21
October, 2003 FDA 483 Response The American National Red Cross - Form 483R, 2003-11-14
February, 2013 FDA 483 Bloodworks - Form 483, 2013-02-15
December, 2012 FDA 483 Sightlife - Form 483, 2012-12-17
October, 2014 FDA 483 Bloodworks - Form 483, 2014-10-15
December, 2003 FDA 483 Response Biomat USA, Inc. - Form 483R, 2004-01-26
May, 2015 FDA 483 Weimin Li - Form 483, 2015-05-17
November, 2010 FDA 483 Kentucky Blood Center Inc - Form 483, 2010-11-05
May, 2015 FDA 483 Jinming Liu - Form 483, 2015-05-08
December, 2003 FDA 483 Biomat USA, Inc. - Form 483, 2003-12-04
October, 2014 FDA 483 Response Bloodworks - Form 483R, 2014-10-31
February, 2013 FDA 483 Response Bloodworks - Form 483R, 2013-03-05
July, 2012 FDA 483 Xtant Medical Holdings Inc - Form 483, 2012-07-26
September, 2003 FDA 483 Response Bloodworks - Form 483R, 2003-09-30
September, 2003 FDA 483 Bloodworks - Form 483, 2003-09-12
September, 2013 EIR Biomat USA, Inc. - EIR, 2013-09-23
January, 2004 FDA 483 Oregon Health & Science University - Form 483, 2004-01-14
September, 2013 FDA 483 Biomat USA, Inc. - Form 483, 2013-09-23
May, 2015 FDA 483 Response Jinming Liu - Form 483R, 2015-05-20
October, 2003 EIR The American National Red Cross - EIR, 2003-10-20
July, 2008 FDA 483 Creative Testing Solutions - Form 483, 2008-07-28

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