FDA 483 - Brien E. Pierpont, M.D. - February 26, 2026

An FDA inspection of Advance Medical Research, Inc. in Saint Petersburg, FL, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to conduct investigations in accordance with the signed statement of investigator and investigational plan, leading to issues with subject eligibility, incorrect treatment stratification, and missing laboratory samples. These findings indicate a failure to adhere to study protocols and regulatory requirements.