FDA 483 - Aslan T Turer, M.D. - August 16, 2023
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An FDA inspection of Aslan T Turer, M.D. in Dallas, TX, from August 8-16, 2023, revealed significant deficiencies in maintaining adequate case histories for a clinical study on Hypertrophic Cardiomyopathy. The clinical investigator failed to properly document reviews of laboratory reports, ECGs, echocardiograms, dose adjustments, and adverse event inquiries for study subjects. These issues indicate a lack of adherence to protocol requirements and proper record-keeping practices.
ID · 43c7e98b-ac0a-493e-a05e-a72806d4f102