FDA 483 - Richard H. Hass, M.D. - May 13, 2022

Richard H. Haas, M.D., a Sponsor Investigator in La Jolla, CA, was cited for inadequate investigational drug disposition records during an FDA inspection. The inspection revealed discrepancies between dispensed drug quantities and subject maintenance dose logs, as well as incomplete records for the destruction of returned investigational drug kits. These findings indicate significant issues with drug accountability and record-keeping in clinical trials.