FDA 483 - Evan Russell, DO - October 10, 2025

An FDA inspection of Evan Russell, DO NKC Health Medical Group, conducted from October 6-10, 2025, identified several significant compliance deficiencies documented in a Form 483. The observations relate to the conduct of a clinical investigation and adherence to regulations governing human subject protection. Key issues included a failure to promptly report an unanticipated problem—specifically, a seven-month screening hold due to enrollment and compliance concerns—to the Institutional Review Board (IRB), contrary to regulatory requirements and the site's own procedures. The investigation was also found not to be conducted according to the approved plan, as two subjects were enrolled without meeting critical inclusion criteria, and 19% of data queries, some over 180 days old, remained unaddressed. Additionally, inadequate investigational drug accountability records were observed, with no disposition records available for one subject. Finally, the facility implemented changes to research activity, specifically a new study protocol, without obtaining prior IRB approval. The medical group is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations for clinical trials and human subject protection.