FDA 483 - Ashok Muthukrishnan, M.D. - June 02, 2025

An FDA inspection of Florida Theranostics (Ashok Muthukrishnan, M.D.) in Jupiter, FL, identified a significant issue with the conduct of a clinical study. The investigation was not performed in accordance with its approved plan, specifically regarding subject eligibility. Four out of six enrolled subjects were found to be ineligible due to unmet inclusion/exclusion criteria and a failure to perform required screening procedures.