FDA 483 - Mohammad A. Mahmud, M.D.

An FDA inspection of Idalia A. Acosta, MD, a clinical investigator in Miami Lakes, FL, revealed significant deficiencies in the conduct and documentation of a clinical investigation. Observations included the failure to retain complete source data, such as subject diaries and case report forms, and a lack of documentation regarding subject eligibility determinations, which was a responsibility not properly delegated.