FDA 483 - Drissana T. Tran, MD - October 11, 2024

An FDA inspection of Drissana T. Tran, MD, a clinical investigator operating at Salem Free Clinic in Salem, OR, revealed a significant failure in maintaining adequate and accurate case histories for a human clinical study under an IND. Specifically, the investigator failed to document assessments of adverse event relatedness to the study drug for numerous adverse events experienced by all 19 subjects. This indicates a serious lapse in record-keeping for clinical trial data.