FDA 483 - Diana P Castro, MD - November 26, 2025

An FDA inspection of Diana P Castro, MD, a clinical investigator in Flower Mound, TX, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to ensure subjects met eligibility criteria and did not adhere to protocol-required assessments and timelines. Additionally, the inspection found multiple instances of incomplete, inaccurate, and non-contemporaneous documentation in case histories, raising concerns about data integrity and overall study oversight.