FDA 483 - Seth M.Pollack, M.D. - June 27, 2019

An FDA inspection of Fred Hutchinson Cancer Research Center in Seattle, WA, identified multiple significant deviations in the conduct of a clinical investigation. Key issues included enrolling ineligible subjects, failing to properly re-consent participants, not adhering to protocol-specified procedures, and deficiencies in IRB review and approval processes for informed consent documents and Investigator Brochures. These findings highlight critical lapses in clinical trial oversight and subject protection.