Harinath Sheela, MD – FDA 483, Jul 2, 2026

An FDA inspection of Harinath Sheela, MD in Orlando, FL, revealed significant deficiencies in maintaining adequate and accurate case histories for clinical trials. The firm failed to ensure subject eligibility through consistent documentation, lacked proper record-keeping for procedures, and exhibited multiple data discrepancies and non-contemporaneous data entry. These issues raise serious concerns about the integrity and reliability of the clinical trial data.