FDA 483 - Stephen K. Tyring, MD, PhD - September 20, 2018

An FDA inspection of Stephen K. Tyring, MD, PhD in Houston, TX, revealed significant deficiencies in clinical trial conduct. Observations included failure to follow the investigational plan regarding efficacy assessments and the use of medical scribes, leading to concerns about data integrity. Additionally, the firm failed to promptly report a serious adverse event to the trial sponsor as required by the protocol.