FDA 483 - Anish J. Thomas, M.D. - January 31, 2025

An inspection of Anish J. Thomas, M.D., a clinical investigator in Saint Louis, MO, revealed significant deficiencies in clinical trial conduct. Observations included inaccurate and incomplete subject case history records, with numerous discrepancies between eCRF data and source documentation. Additionally, the firm failed to conduct investigations according to the investigational plan, specifically regarding medication recording, required blood draws, and timely reporting of Serious Adverse Events.