FDA 483 - Jason A. Ohayon, MD - November 12, 2025

An FDA inspection of Jason A. Ohayon, MD, a clinical investigator in Hamilton, ON, revealed a failure to conduct a clinical study according to good clinical practices. The site did not follow the investigational plan and maintain adequate case histories for pharmacokinetic sample processing and shipment. This included a lack of records for sample handling and improper co-shipment of primary and backup samples.