‘Objectionable Conditions’ at Clinical Investigation Site

A 10/18/21-10/29/21 FDA Bioresearch Monitoring Program inspection at a clinical site maintained by Dr. Adarsh Daswani in La Palma, CA, found “objectionable conditions” in his conduct of a clinical investigation of an investigational drug. A 12/14/22 Warning Letter says it appears that Daswani failed to adhere to applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. The letter says Daswani failed to ensure that the investigation was conducted according to the investigational plan.

“We emphasize that your failure to conduct the clinical study in accordance with the protocol raises significant concerns about your protection of the study subjects enrolled at your site, and also raises concerns about the validity and integrity of the data collected at your site,” FDA says.

Daswani was told to respond with specific actions he has taken to prevent similar violations in the future.