FDA EIR - Ian M. Baird MD - July 10, 2019

An FDA inspection of Dr. Ian M. Baird MD at Remington-Davis Clinical Research was conducted from July 1-10, 2019. This was a directed follow-up inspection under Compliance Program 7348.811 for Clinical Investigators, aimed at verifying corrective actions implemented since a 2017 inspection classified as "Official Action Indicated" (OAI). The previous OAI stemmed from the clinical investigator's failure to adhere to the investigational plan, specifically concerning the enrollment of ineligible subjects.The current comprehensive inspection reviewed two clinical protocols, focusing on regulatory records, subject documentation, and Institutional Review Board (IRB) processes. The inspector verified several key corrections: physician investigators now thoroughly review subject eligibility, medical histories are maintained with prohibited medication lists, investigational product accountability logs are accurate, and subject comprehension of consent forms is confirmed through a site-specific procedure.Significantly, no new objectionable conditions were identified during this inspection, and a Form FDA-483 was not issued. This indicates successful implementation of the previously required corrective actions, demonstrating the site's compliance with regulatory standards for clinical investigations. No further immediate regulatory actions were mandated.