FDA EIR - Diego A. Rielo, M.D. - June 15, 2024

An FDA inspection of Clinical Investigator Dr. Diego A. Rielo, M.D., operating at Premier Clinical Research Institute in Miami, Florida, was conducted from June 10-14 and June 18-21, 2024. This comprehensive, for-cause inspection fell under the Prescription Drug User Fee Act (PDUFA) and Compliance Program 7348.811 for Bioresearch Monitoring.

The inspection identified significant violations of the Federal Food, Drug, and Cosmetic (FD&C) Act, detailed in a Form FDA 483. Key observations included the failure to conduct investigations in accordance with the signed investigational plan: one subject was enrolled despite not meeting inclusion criteria due to prohibited medication use, and source data (e.g., vitals) were not captured in real-time. Furthermore, the firm failed to maintain adequate and accurate case histories, evidenced by obliterated information on ECG printouts without proper attribution. Other concerns raised during discussions involved delayed subject assessments, improper medical record corrections, missing documentation, and issues with investigational product accountability.

Dr. Rielo was informed that these conditions could result in administrative actions, injunctions, fines, or prosecution. He is required to submit an adequate response to the FDA Form 483 within 15 business days to address the observations and mitigate potential further agency action.