FDA EIR - Wayne Farnsworth, MD - June 27, 2023

An FDA inspection of Wayne Farnsworth, MD, a clinical investigator in Rockville, MD, was conducted from June 20 to June 27, 2023. This routine inspection, performed under the Federal Food, Drug, and Cosmetic Act (FFDCA) for Investigational New Drug (IND) applications and compliance program 7348.811, revealed significant regulatory issues. The primary violation, documented on an FDA-483, highlighted that the investigation was not conducted according to the signed statement of investigator and investigational plan (21 CFR 312.60). Specifically, approximately 111 protocol-required assessments were missed after Dr. Farnsworth became the Principal Investigator, with representative samples confirming missing source documentation. Additionally, two discussion items were raised: a failure to promptly report an aggregate of missed subject assessments to the Institutional Review Board (IRB), and delayed notification to the IRB concerning a fourth subject affected by suspected scientific misconduct. This misconduct involved a former site manager falsifying patient assessment records for subjects who were hospitalized, out of the country, or deceased. Dr. Farnsworth committed to providing a written response to the FDA-483 within 15 business days. He also pledged to investigate and improve internal procedures for IRB reporting and assess further corrective actions regarding the discussion item findings.