FDA 483 - Herman Ayvazyan, M.D. - January 25, 2024

Herman Ayvazyan, M.D. in East Providence, RI, was inspected by the FDA from January 18-25, 2024, as a clinical investigator. The inspection revealed a significant issue regarding the maintenance of adequate case histories, specifically the permanent de-identification of informed consent forms for a clinical study. This indicates a serious lapse in record-keeping and subject protection protocols.