FDA 483 - Cassie L. Blanchard, PhD - June 13, 2023

An FDA inspection of Cassie L. Blanchard, PhD, a clinical investigator in Berlin, NJ, revealed significant deviations from investigational plans and inadequate record-keeping. Observations included failures to conduct subject assessments according to protocol and a lack of contemporaneous completion or source records for case histories. These findings indicate serious concerns regarding the integrity and conduct of clinical studies.