FDA EIR - Saadeh, Ghandi, M.D. - February 04, 2009

An FDA inspection was conducted at the clinical research site of Dr. Ghandi M. Saadeh, M.D., located in Norfolk, VA, associated with Sentara Medical Group/Norfolk Diagnostic Center. The inspection, which spanned from December 8, 2008, to February 4, 2009, focused on three clinical research protocols involving investigational new drugs, under the FDA's Clinical Investigators Compliance Program 7348.811. The inspection revealed significant violations related to the integrity of study data and conduct. Key issues included the failure to maintain adequate and accurate case histories, missing or photocopied subject diaries with allegations of fabrication, and unaccounted-for study medications. Furthermore, the report documented instances of fabricated laboratory results, enrollment of subjects taking prohibited medications, and broader scientific misconduct such as fabricating source documents, electronic case report forms, and falsifying diaries and enrollment criteria. These issues led to the premature discontinuation of Dr. Saadeh's participation in two of the three clinical studies by their respective sponsors. During the close-out meeting, Dr. Saadeh acknowledged and agreed with all findings presented in the FDA 483 Inspectional Observations, stating he was already aware of the problems through internal audits. He committed to implementing standard operating procedural changes. While a formal response to the FDA 483 was noted as the site's prerogative, the seriousness of the findings underscores the necessity for comprehensive corrective actions to ensure compliance with good clinical practices.