FDA Investigator Linda S Leja

Linda S Leja has conducted inspections on 44 sites in 9 countries as of 25 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
44
Last Inspection Date:
25 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100005223
Countries of Inspections:
United States of America, Canada, Denmark, Germany, Italy, Czechia, Russian Federation, Netherlands, Switzerland
FDA Investigators that have inspected at least one site in common with Linda S Leja:
Andrew K Haack, PhD, Andrew R Wasko, Anita Narula, PhD, Astrida B Mattson, Barbara Janine Breithaupt, Brenda L Reihing, Carl A Anderson, Charles R Bonapace, PhD, Connie P Rezendes, Ct Viswanathan, PhD, Cynthia L Gorveatt, Dawn E Barkans, Dolores E Price, Donald B Mckechnie, Dov H Pluznik, PhD, Dr. Mark J Seaton, PhD, Dr. Zhou Chen (nmi), MD PhD, Dylan D Yao, MD, PhD, Erin M Mcdowell, Gajendiran Mahadevan, PhD, Gloria J Baca, MS, Grace P Santos, Heika R Bounds, Heika R Tait, Hugh M Mcclure, II, Jacqueline A O'shaughnessy, PhD, James M Kewley, Jane M Kreis, John A Iwen, Joseph P Iser, MD, Julia E Chervoni, Julian C Hanson, June H Wetherington, Kathryn A Krentz, Lawrence Y Lee, PhD, Lisa K Capron, Lori J Silverstein, Maria Pkelly Doggett, MBA, Marijo B Kambere, PhD, Mark W Babbitt, Michael C Rogers, Michael F Skelly, PhD, Mikel T Wright, Mohsen Rajabi Abhari, FDA, Nancy A Saxenian Emmons, Nancy E Byerly, Paul M Kawamoto, Paula A Trost, Randy L Self, Richard S Andros, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Rocco C Black, S Lori Brown, PhD MPH, Sangeeta M Khurana, PhD, Sharon I Gundersen, Sherri N Rohlf, MD, Sripal R Mada, PhD, Stanley B Eugene, BS, BME, Stephanie A Slater, MS, Sunitha K Rajaram, PhD, Susan D Yuscius, Susan E Molchan, MD, Susan T Hadman, Terri L Dodds, Vanessa Y Gelsey, PhD, Veronica L Bush, Virgilio F Pacio, CSO, Xikui Chen (nmi), PhD

Linda S Leja's Documents

Publish Date Document Type Title
October, 2001 FDA 483 Fred Hutchinson Cancer Research Center - IRB - Form 483, 2001-10-26
December, 2000 FDA 483 Altasciences Preclinical Seattle, LLC - Form 483, 2000-12-19
August, 2000 FDA 483 SNBL USA Biosupport , Ltd. - Form 483, 2000-08-10
April, 2000 FDA 483 Pascal Company, Inc. - Form 483, 2000-04-25
April, 2000 EIR Pascal Company, Inc. - EIR, 2000-04-25
March, 2001 FDA 483 Response Algorithme Pharma Inc. - Form 483R, 2001-03-23
October, 2001 EIR Pascal Company, Inc. - EIR, 2001-10-22
June, 2000 EIR Peter Haeck - EIR, 2000-06-22
June, 2000 EIR Dr. Klein - EIR, 2000-06-15
June, 2001 FDA 483 Response Fred Hutchinson Cancer Research Center - IRB - Form 483R, 2001-08-01
February, 2000 FDA 483 University of Washington - Form 483, 2000-02-23
August, 2000 FDA 483 Comprehensive Clinical Development Northwest, Inc - Form 483, 2000-08-07
April, 2001 FDA 483 Thomas M. Kennefick, M.D. - Form 483, 2001-04-20
December, 2000 EIR Altasciences Preclinical Seattle, LLC - EIR, 2000-12-19
January, 2001 EIR Ricks Warren, Ph.D. - EIR, 2001-01-05
April, 2000 EIR Immunex Corp. - EIR, 2000-04-05
August, 2000 EIR SNBL USA Biosupport , Ltd. - EIR, 2000-08-10
April, 2001 EIR Thomas M. Kennefick, M.D. - EIR, 2001-04-20
August, 2000 EIR Comprehensive Clinical Development Northwest, Inc - EIR, 2000-08-07
February, 2001 FDA 483 Cook David M. M.D - Form 483, 2001-02-02
July, 2000 EIR Irina Y. Demidova - EIR, 2000-07-25
February, 2001 EIR Cook David M. M.D - EIR, 2001-02-02
October, 2001 EIR Dana C. Matthews, MD/PI - EIR, 2001-10-26
July, 2000 FDA 483 Response Irina Y. Demidova - Form 483R, 2000-07-06
June, 2001 FDA 483 Fred Hutchinson Cancer Research Center - IRB - Form 483, 2001-06-27
November, 2001 EIR Johnson Edward G Dvm - EIR, 2001-11-01
June, 2000 EIR Italo Fumagalli - EIR, 2000-06-29
July, 2001 EIR Peter Gebuhr, M.D. - EIR, 2001-08-02
June, 2001 EIR Fred Hutchinson Cancer Research Center - IRB - EIR, 2001-06-27
March, 2001 FDA 483 Algorithme Pharma Inc. - Form 483, 2001-03-09
June, 2000 FDA 483 Response Peter Haeck - Form 483R, 2000-08-17
March, 2001 EIR Algorithme Pharma Inc. - EIR, 2001-04-02
July, 2001 EIR Dr. Z. Krska - EIR, 2001-07-19
February, 2000 EIR Thomas Winter, M.D. - EIR, 2000-02-23
June, 2000 FDA 483 Response Dr. Klein - Form 483R, 2000-09-05
September, 2001 EIR Arifulla Khan MD - EIR, 2001-09-21
July, 2001 FDA 483 Peter Gebuhr, M.D. - Form 483, 2001-07-13
September, 2001 FDA 483 Arifulla Khan MD - Form 483, 2001-09-21
June, 2000 FDA 483 Response Italo Fumagalli - Form 483R, 2000-06-29

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