Mark Clemens M.D. – FDA 483, Aug 6, 2026

An FDA inspection of Mark Clemens M.D. in Houston, TX, a clinical investigator, revealed significant deviations from investigational plans and applicable FDA regulations. The firm failed to report serious adverse events to the sponsor within the required timeframe and did not return explanted investigational devices for evaluation as mandated by protocol. These findings indicate a moderate level of non-compliance in clinical trial conduct.