‘Objectionable Conditions’ in Bioresearch Monitoring Inspection

A 5/12-5/16/2025 FDA Bioresearch Monitoring Program inspection at the clinical trial site maintained by Dr. Bertrand Cole in Portsmouth, NH, found objectionable conditions in two clinical investigations. A 2/2 Warning Letter says Cole failed to ensure that the investigation was conducted according to the investigational plan.

In the letter, FDA acknowledges the corrective and preventive actions the clinical site has taken, but finds that Cole’s response to the inspection was inadequate because he did not include sufficient details about the training or procedures implemented at the site to prevent similar violations in the future. The response also did not provide sufficient details about how Cole, as the clinical investigator, will ensure adequate oversight of study procedures.

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