FDA 483 - Patrick S. Lynch, MD - April 19, 2021

An FDA inspection of Patrick S. Lynch, MD in Houston, TX, revealed significant deficiencies in clinical trial conduct. Observations included failures to promptly report serious adverse events to the sponsor, non-adherence to the study protocol regarding subject assessments, and improper documentation of informed consent forms. These findings indicate a need for improved oversight and adherence to regulatory requirements for clinical investigations.