FDA 483 - Adam Peyton, D.O. - October 26, 2023

An FDA inspection of Northeast Clinical Research Center, LLC in Bethlehem, PA, a clinical investigator site, revealed significant deviations from investigational plans and good clinical practices. Observations included investigations not conducted according to the signed statement of investigator, with unqualified personnel performing safety assessments and physical examinations, and a lack of proper clinical investigator oversight. Additionally, the firm failed to maintain adequate and accurate case histories and source documentation regarding study activities and informed consent processes.