Naseem Jaffrani BIMO Violation

A 2/14-3/13/2025 FDA Bioresearch Monitoring Program inspection at a clinical site operated by cardiologist Naseem Jaffrani in Alexandria, LA, found he did not follow statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. A 5/4 Warning Letter says Jaffrani failed to ensure that an investigation was conducted according to the investigational plan.

The letter acknowledges the corrective and preventive actions Jaffrani has taken and plans to take, but says his response to the form FDA-483 inspection findings is inadequate because he did not provide sufficient details on how he, as the lead investigator, will ensure adequate supervision and oversight of study personnel to whom he has delegated study procedures and tasks, and how he will prevent similar violations from occurring in the future.

Jaffrani was told to respond with a list of specific actions he is taking to prevent the violations from recurring in the future.