FDA 483 - Stephen G. Thein, Ph.D. - April 25, 2025

Pacific Research Network (PRN) in San Diego, a clinical investigator, was cited for failing to conduct an investigation in accordance with its investigational plan. Specifically, participants who tested positive for cannabinoids were allowed to continue in a study without termination or proper reporting. Additionally, the firm implemented changes in research activity without prior Institutional Review Board (IRB) approval.