FDA EIR - Robert Michael Murray, MD - September 14, 2006

The FDA conducted an unannounced inspection of Dr. Robert Michael Murray, a Clinical Investigator in Homewood, AL, from September 11-14, 2006. The inspection, conducted under Compliance Program 7348.811 for Clinical Investigators, focused on a study involving an investigational drug for acute bacterial sinusitis. The primary violation identified was a failure to conduct the investigation in accordance with the investigational plan, resulting in the issuance of an FDA-483, List of Inspectional Observations. Specifically, four out of ten subjects enrolled by sub-investigators at an affiliated site did not meet the study's inclusion criteria. Dr. Murray, the Principal Investigator, demonstrated a lack of adequate oversight over these sub-investigators, admitting he was not in regular communication with them, nor aware that screening x-rays for their subjects were re-read by a second radiologist to alter initial findings and allow enrollment. This included subjects with initially normal x-rays or pre-existing exclusionary conditions being improperly enrolled. Additional concerns involved potentially unreported concomitant medications and adverse events. The inspection underscored Dr. Murray's ultimate responsibility under the regulatory framework of 21 CFR 312.60 for all aspects of the study, even when tasks are delegated. While no specific 'required actions' beyond the FDA-483 are explicitly detailed, the expectation is for Dr. Murray to address these observations and enhance his oversight and adherence to the investigational plan to ensure subject safety and data integrity in future clinical trials.