FDA 483 - George Timothy Kelly. M.D. - February 15, 2024

An FDA inspection of G. Timothy Kelly, M.D. in Las Vegas, NV, revealed significant deviations from study protocols and inadequate record-keeping for investigational products. Observations included failures in conducting required subject analyses and assessments, issues with eligibility determination, and poor investigational drug accountability. These findings indicate a lack of adherence to clinical investigation standards.