Issues at San Francisco Research Institute

A 4/9-4/17/2024 FDA Bioresearch Monitoring Program inspection at the San Francisco Research Institute operated by Dr. Mark Savant found the site did not adhere to the law and regulations governing the conduct of clinical investigations and the protection of human subjects in its conduct of a clinical investigation of an investigational drug. A 6/26 Warning Letter says the specific violations were:

• failure to ensure that the investigation was conducted according to the investigational plan; and
• failure to obtain informed consent consistent with regulations.

The letter acknowledges the corrective and preventive actions that Savant and the site have taken and plan to take, but says the response is inadequate because it did not provide sufficient detail about the policies, procedures, and training plan being implemented at the site to prevent similar violations in the future.

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