FDA 483 - Mohammed Ansari - September 16, 2021

An FDA inspection of Texas Tech University Health Sciences Center in Lubbock, TX, identified a significant issue with the timely reporting of Serious Adverse Events (SAEs). The clinical investigator failed to adhere to the investigational plan and internal procedures, resulting in multiple instances of delayed SAE reporting to the Institutional Review Board (IRB). This indicates a lapse in human subject protection protocols.