FDA 483 - Kennedy, Philip R.

An FDA inspection conducted from October 2-16, 2019, at Philip R. Kennedy, M.D., PhD's facility in Duluth, GA, identified nine significant observations on a Form FDA 483 regarding an investigational device study. Dr. Kennedy, serving as a Sponsor-Investigator, was cited for non-compliance with regulations governing clinical investigations. The primary violations centered on a pervasive lack of Institutional Review Board (IRB) oversight and inadequate study monitoring, including no documented continuing IRB review since 2002 and no monitoring activities since 2009, despite ongoing subject participation—a repeated observation. Dr. Kennedy also failed to secure informed consent for post-mortem tissue collection and neglected to notify the FDA and IRBs about device repairs or disposals within the stipulated 30 working days. Other critical issues, many of which were repeated from a previous inspection, included the absence of written monitoring procedures, failure to submit annual progress reports to FDA and IRBs for numerous years (2010-2018), and the untimely reporting of serious adverse events within 10 working days. Furthermore, essential study records, such as informed consent and medical documents, were not consistently maintained, and financial disclosure agreements from all participating investigators were lacking. Corrective actions are required to rectify these systemic deficiencies, focusing on establishing comprehensive IRB approval and continuing review processes, implementing robust study monitoring, ensuring proper informed consent, timely reporting of all adverse events and device modifications, maintaining accurate and complete study records, and securing all necessary financial disclosures.