William E. Kirby, MD – FDA EIR, Aug 4, 2016

An FDA inspection was conducted at William E. Kirby, MD, located at Simon Williamson Clinic, PLLC, from August 1-4, 2016. This initial, high-priority inspection was assigned by the Center for Biologics Evaluation and Research (CBER) to assess the clinical investigator's conduct of an Investigational New Drug (IND) study evaluating a new vaccine. The regulatory framework for this inspection involved compliance with FDA regulations governing clinical trials, specifically under the Prescription Drug User Fee Act (PDUFA). The inspection comprehensively reviewed 32 subject binders, informed consent forms, drug accountability logs, monitoring records, and financial disclosures. A notable finding was that no deficiencies were identified, and consequently, no FDA-483 (Inspectional Observations) was issued. The inspector did seek clarification on the Institutional Review Board (IRB) approval process, specifically regarding expedited reviews for subsequent study sites, but this point was resolved with clarification from the IRB during the inspection. Given the absence of findings, no specific required actions were mandated for the company. At the conclusion of the inspection, Dr. Kirby was informed of the FDA's potential enforcement actions for non-compliance, such as warning letters or disqualification of data or the investigator, emphasizing responsibilities even in a compliant inspection.