FDA 483 - Mehran Michael Bahrami, M.D. - April 19, 2024

During an FDA inspection conducted from April 8 to April 19, 2024, Mehran Michael Bahrami, M.D., a clinical investigator, received a Form FDA 483 detailing significant observations of non-compliance with regulatory requirements for clinical trials. The primary issues centered on fundamental aspects of human subject protection and study conduct. Specifically, the firm failed to obtain proper informed consent from subjects prior to administering investigational products, a direct violation of 21 CFR Part 50. Furthermore, the investigation was not conducted in accordance with the agreed-upon investigational plan, demonstrating inadequate oversight. This included enrolling subjects who met exclusion criteria, improper dosing of investigational products, and conducting virtual visits instead of required in-person safety assessments, leading to missing crucial data. Additionally, laboratory specimens for safety tests were often improperly collected, prepared, or shipped, resulting in invalid or missing test results. The FDA also noted severe deficiencies in record-keeping. Case histories were incomplete, lacked proper attribution, and essential documentation such as IRB approvals for one protocol and comprehensive COVID-19 test details were missing. Critical identifying information on ECG tracings was obliterated. Finally, required investigational records, including case report forms, were not available for review during the inspection. These observations highlight a systemic breakdown in adherence to good clinical practice and regulations, necessitating a comprehensive response from Mehran Michael Bahrami, M.D., outlining corrective actions.