FDA 483 - Sait Ashina, M.D. - April 08, 2025

Dr. Sait Ashina, M.D., a clinical investigator in Boston, MA, was cited for significant deviations from investigational plans and inadequate record-keeping during an FDA inspection. The inspection revealed failures to adhere to study protocols, including enrolling ineligible subjects and not completing required monitoring, as well as issues with maintaining complete and timely case histories. These findings indicate serious deficiencies in the conduct and documentation of clinical trials.