FDA 483 - Shaila U. Gogate, M.D. - April 24, 2025

An FDA inspection of Shaila U. Gogate, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in subject eligibility screening, inadequate review of adverse events, and issues with informed consent and maintaining accurate case histories. These findings indicate a lack of adherence to study protocols and regulatory requirements, potentially impacting data integrity and subject safety.