FDA 483 - Mark V. DiBuono, MD - May 31, 2024

An FDA inspection of Mark V. Dibuono, MD, a clinical investigator in Staten Island, NY, revealed significant deviations from an investigational plan. The firm failed to adhere to protocol exclusion criteria by enrolling a subject with an excessive BMI and did not follow stopping criteria for another subject who met the specified weight loss threshold, continuing to administer investigational product in both instances. These findings indicate a failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan.