FDA WARNING_LETTER - Americo F. Padilla, MD - February 16, 2024

The FDA issued a Warning Letter to Dr. Padilla following an inspection from February 1 to February 16, 2024, under the Bioresearch Monitoring Program. The inspection revealed non-adherence to the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312, specifically regarding informed consent.

The primary violation was the failure to obtain legally effective informed consent for pediatric subjects in Protocol (b)(4), a clinical trial for children and adolescents aged 6 to under 18, classified under 21 CFR 50.52. The IRB required parental/guardian permission documented per 21 CFR 50.27.

Specifically, Subject (b)(6) was enrolled on October 10, 2022, with a sibling signing consent, but parental permission was not obtained until approximately 10 months later. Subject (b)(6) was enrolled on November 16, 2022, with an uncle signing consent, but parental permission was not obtained until approximately 9 months later.

Dr. Padilla's February 28, 2024, response attributed the issue to documentation errors and proposed corrective actions including obtaining retrospective parental consent and implementing new procedures for verifying legal guardianship and separate parental permission forms. However, the FDA found the response inadequate, lacking sufficient detail on how proper documentation for minors' consent would be ensured and how the quality assurance process