FDA 483 - Richard D. Guyer, MD - February 10, 2020

An FDA inspection of Richard D. Guyer, MD, a clinical investigator in Plano, TX, revealed significant deficiencies in conducting a clinical investigation. The firm failed to adhere to the signed investigator's agreement and study protocol, leading to issues with subject eligibility and the proper reporting of adverse events. These findings indicate a lack of control over critical aspects of clinical trial conduct.