Pilar F. Trueba, M.D. – FDA EIR, Apr 2, 2024

An FDA inspection of Pilar F. Trueba, M.D., located in Miami, FL, was conducted from March 21, 2024, to April 02, 2024. This high-priority inspection focused on the clinical investigator's activities related to two drug protocols, under the regulatory framework of Compliance Program 7348.811, Bioresearch Monitoring Clinical Investigators and Sponsor-Investigators. The inspection encompassed areas such as trial administration, protocols, IRB documentation, subject records, informed consent processes, financial disclosures, and investigational product controls. At the inspection's conclusion, a Form FDA 483, Inspectional Observations, was presented to Dr. Trueba. The main violation observed was the failure to prepare or maintain adequate and accurate case histories, which are crucial for investigation data. Furthermore, a discussion item highlighted a failure to adhere to the study protocol. Dr. Trueba was informed that these conditions, upon further agency review, could be deemed violations of the Federal Food, Drug, and Cosmetic Act, potentially leading to administrative actions, injunctions, civil money penalties, or prosecution by the FDA. Dr. Trueba acknowledged all observations.