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

During an inspection conducted from January 23 to May 31, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Mark V. DiBuono, MD, a clinical investigator. The inspection revealed that the investigation for protocol (b)(4) was not conducted in accordance with the signed statement of investigator and the approved investigational plan. Specifically, the FDA noted two critical deviations. First, a subject was enrolled into the clinical trial despite having a Body Mass Index (BMI) that exceeded the protocol's exclusion criteria. This individual was subsequently given the investigational product and remained active in the study. Second, the investigator failed to implement a stopping criterion mandated by the protocol. A subject's BMI decreased to a point that should have triggered the cessation of dosing, yet the investigational product continued to be administered, and the subject remained on the trial. These observations highlight a failure to adhere to established research protocols, which are crucial for ensuring subject safety and data integrity in clinical trials. As an FDA 483, this document serves as a report of objectionable conditions observed during the inspection, requiring the firm to evaluate these findings and provide a comprehensive response detailing corrective actions. This process is part of the regulatory oversight under the Federal Food, Drug and Cosmetic Act.