FDA 483 - Peter Michael, M.D. - June 11, 2024

The FDA inspected G+C Research Group in Hialeah, FL, a clinical investigator, and found significant deficiencies. Observations included the overdosing of subjects with investigational product and a failure to conduct investigations according to the approved plan. Additionally, the firm failed to maintain adequate case histories, with unassessed laboratory reports and missing source documents for multiple subjects.