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

An FDA inspection of Americo F. Padilla, MD in Miami, FL, a clinical investigator, revealed significant deficiencies in the conduct of clinical investigations involving children and adolescents. The firm failed to properly document parental consent for minor subjects, did not adhere to the investigational plan regarding subject eligibility and study procedures, and lacked adequate and accurate case histories with required laboratory results.