FDA 483 - Patrick Odia, MD - February 16, 2024

An FDA inspection of Patrick Odia, MD in Houston, TX, a clinical investigator site, revealed a significant issue regarding the conduct of an investigation. The primary finding was that the investigator failed to adequately supervise the study, specifically concerning the assessment of subject eligibility by a sub-investigator. This indicates a lack of adherence to the signed statement of investigator and the investigational plan.