Alison C. Bested, MD – FDA 483, Jun 12, 2026

An FDA Form 483 was issued to Alison C. Bested, MD, a Sponsor-Investigator in Davis, FL, following an inspection of a clinical investigation. The inspection revealed significant non-compliance, including the failure to submit an Investigational New Drug (IND) application prior to conducting the study. Additionally, the firm failed to maintain adequate case histories and investigational product records, and the study was not conducted according to the investigational plan, leading to subject overdosing and unreported adverse events.