FDA EIR - Michele Sewell - August 19, 2013

An FDA inspection was conducted at Michele Sewell, MD, located at Stonecrest Pediatric and Adult Medicine in Lithonia, GA, from June 17 to August 19, 2013. This high-priority, for-cause inspection was initiated by the Good Clinical Practice Enforcement Branch of the FDA's Office of Scientific Investigations, under Compliance Program 7348.811 for Clinical Investigators, due to reported significant non-compliance at the site. The inspection focused on two GlaxoSmithKline studies concerning Type 2 Diabetes Mellitus.

The review encompassed study administration, Institutional Review Board (IRB) approvals, subject selection, informed consent, data evaluation, adverse event reporting, and investigational product accountability. The inspection revealed significant deficiencies, leading to the issuance of a Form FDA 483, Inspectional Observations. Key violations included the failure to conduct investigations in accordance with the signed investigator statement and study plan, a lack of adequate and accurate case histories, and the failure to promptly report unanticipated problems involving risk to human subjects to the IRB.

During the closeout meeting, discussions with management emphasized the need for proper documentation of study procedures, counseling subjects on adherence, and thorough evaluation of adverse events. This marked Dr. Sewell's first FDA inspection.