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

An FDA inspection conducted from November 10-12, 2025, identified significant issues at the clinical investigator site of Dr. Jason A. Ohayon in Hamilton, ON. The primary observation was a failure to conduct a clinical study in accordance with good clinical practices, specifically concerning the handling and documentation of pharmacokinetic (PK) samples. The site did not adhere to the investigational plan and failed to maintain adequate case histories. Key violations included the absence of records detailing PK sample processing, such as post-collection centrifugation times, settings, and storage freezer entry/removal. Furthermore, contrary to protocol, primary and backup PK sample aliquots were improperly shipped together for four subjects instead of separately. Discrepancies were also noted in source documents regarding a subject's blood draw, with an unconfirmed modification lacking supporting processing records. These findings indicate a lack of adherence to established protocols for sample management and data integrity, requiring prompt corrective actions to ensure compliance with federal regulations governing clinical trials.