Francesco Muntoni, M.D. – FDA 483, May 3, 2019

This FDA Form 483 was issued to Francesco Muntoni, M.D., a clinical investigator in London, United Kingdom, following an inspection related to a clinical trial for Duchenne Muscular Dystrophy. The inspection revealed significant deviations from the investigational plan, including improper timing of muscle biopsies, unblinding of study drug information, and incorrect subject dosing. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding documentation for muscle biopsy sample shipments.