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

The FDA issued a Form 483 to Mehran Michael Bahrami, M.D., following an inspection that revealed significant deficiencies in the conduct of clinical investigations. Key issues included failure to obtain informed consent, inadequate oversight of study procedures leading to protocol deviations, and poor record-keeping practices. These findings indicate a lack of adherence to regulatory requirements for human subject protection and data integrity in clinical trials.