Physician-Investigator ‘Objectionable Conditions’

An FDA BIMO (bioresearch monitoring program) 4/8-4/19/2024 inspection of three clinical investigations conducted by Dr. Mehran Bahrami in Adventura, FL, found objectionable conditions that indicate he did not adhere to laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A 3/5 Warning Letter cited:

• failure to ensure that the investigation was conducted according to the investigational plan; and
• failure to retain records required to be maintained for two years following the date a marketing application is approved for the drug for the indication for which the drug was investigated or, if no application is filed or approved, for two years after the investigation is discontinued.

Bahrami was told to respond with a list of specific actions he has taken to prevent similar violations in the future.