‘Objectionable’ Clinical Trial Practices at Florida Clinic

A 6/8-6/23/20 FDA Bioresearch Monitoring Program inspection at a Palmetto, FL, medical practice operated by Evelyn Lopez-Brignoni found objectionable conditions in the practice’s conduct of two clinical trials. A 3/2 Warning Letter says the practice “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.” The letter said Lopez-Brignoni failed to ensure that the investigation was conducted according to the investigational plan.

FDA acknowledges the corrective actions the practice has taken for staff training and the documentation of sponsor communication by site staff. The agency asked that Lopez-Brignoni specify the actions taken as a clinical investigator to prevent similar violations in the future. “We cannot undertake an informed evaluation of your written response until you submit this information,” the letter says.