FDA EIR - PIL - April 02, 2024

An FDA inspection of Pilar F. Trueba, M.D., a clinical investigator in Miami, FL, was conducted from March 21 to April 2, 2024. This comprehensive inspection, requested by the Center for Drug Evaluation and Research under Compliance Program 7348.811 for Bioresearch Monitoring, reviewed two closed clinical trials. The inspection identified significant issues, resulting in an FDA Form 483, Inspectional Observations, and a discussion item. The primary observation was a "Failure to prepare or maintain adequate and accurate case histories." This included at least 20 subjects having assessment times that were impossibly close, and 26 subjects (all randomized) missing required papers and envelopes for a specific assessment item. A discussion item noted a "Failure to follow the protocol," specifically allowing a subject to proceed in a study despite not meeting inclusion criteria. These findings indicate potential violations of investigator recordkeeping requirements, referencing 21 CFR 312.62(b). Dr. Trueba acknowledged the findings and committed to submitting a written response to the FDA within 15 business days, along with a commitment to maintaining original records and ensuring proper adherence to inclusion/exclusion criteria in future studies. The FDA warned that these conditions could lead to various administrative and legal actions.