FDA 483 - Americo F. Padilla, MD - February 16, 2024

An FDA inspection conducted between February 1 and February 16, 2024, at a facility overseen by Clinical Investigator Americo F. Padilla, identified significant deficiencies in the conduct of a Phase 3 clinical trial (Protocol BHV3000-315) evaluating migraine prevention in children and adolescents. The inspection revealed three primary observations.

First, proper documented parental or legally authorized representative consent was lacking for seven out of fifteen minor subjects screened, violating 21 CFR 50.27, which mandates documented permission for children's participation in clinical investigations. Second, the study was not conducted in strict accordance with the approved investigational plan. This included the randomization of two subjects who did not meet inclusion/exclusion criteria (being from the same household), one subject receiving incorrect investigational product kits, and another subject's Week 14 visit remaining incomplete as per protocol requirements.

Finally, the clinical investigator failed to prepare and maintain adequate and accurate case histories. Crucial pre-randomization laboratory results (serum pregnancy test, urine drug screen) were missing for two subjects, and essential protocol-required laboratory results (such as Liver Function Tests, Chemistry, and Urinalysis) were absent for four subjects. These observations highlight an urgent need for the clinical investigator to address these issues to ensure regulatory compliance and the integrity of the clinical study.