FDA 483 - Saranya Chumsri MD - September 10, 2020

An FDA inspection of Saranya Chumsri MD, a Sponsor-Investigator in Jacksonville, FL, revealed a significant failure to adhere to human subject protection protocols. The firm failed to promptly report critical information, specifically findings from a Data Safety Monitoring Committee re-audit and the temporary closure of a clinical study, to the Institutional Review Board (IRB). This oversight led to the IRB suspending subject enrollment for the study, highlighting a serious lapse in regulatory compliance.