FDA 483 - Valerie K Arnold MD - March 15, 2017

An FDA inspection of Valerie K Arnold MD, operating within CNS Healthcare in Memphis, TN, was conducted from March 13-15, 2017. This pre-announced PDUFA inspection, performed under Compliance Program 7348.811 for Clinical Investigators, aimed to assess compliance with clinical trial regulations. The inspection reviewed two specific protocols, including 100% of source documentation, subject eligibility, informed consent processes, and test article accountability. The regulatory review concluded that no objectionable conditions or significant deficiencies were identified. Study records were found to be complete, legible, organized, and verifiable, with activities conducted in compliance with protocols. Informed consent was properly obtained, and Institutional Review Board (IRB) approvals were maintained. While a minor observation involved a slight discrepancy in blood pressure limit calculations and a single inconsequential data entry error, these were determined to have no impact on the study data. No formal violations requiring corrective action were issued; however, management indicated plans to enhance training on blood pressure chart interpretation for future studies. Regulatory warnings were provided in accordance with district policy.