FDA 483 - Tran-Johnson, Tram K. - February 01, 2019

An FDA inspection of Ryan-Johnson, Tram K., a clinical investigator in San Diego, revealed two significant observations. The firm failed to report adverse effects related to an investigational drug to the sponsor, including severe orthostatic hypotension, syncope, and worsening drowsiness. Additionally, the firm failed to maintain adequate case histories, specifically by not transcribing a subject's history of suicide ideation into study records.