Americo F. Padilla, M.D./Miami Dade Medical Research Institute – FDA Warning Letter, Feb 16, 2024

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Dr. Padilla following an inspection of their clinical site conducted from February 1 to February 16, 2024. The inspection, part of the Bioresearch Monitoring Program, identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 312, specifically concerning human subject protection and informed consent.

The main issue was the failure to obtain legally effective informed consent for two pediatric subjects enrolled in Protocol (b)(4), an investigational drug study, prior to their participation. Consent forms were improperly signed by a sibling and an uncle, neither of whom were the subjects" legal guardians, and proper parental permission was secured 9-10 months after the subjects were already enrolled. This violation of 21 CFR part 50, which governs informed consent for human subjects, especially for vulnerable pediatric populations, jeopardized the rights and welfare of these subjects.

While Dr. Padilla submitted a response outlining corrective and preventive actions, the FDA found it lacked sufficient detail to adequately assess its effectiveness in preventing future systemic failures. The Warning Letter emphasizes Dr. Padilla"s ultimate responsibility as the clinical investigator to ensure full compliance with all applicable FDA regulations, urging a comprehensive address of all deficiencies.