FDA 483 - Caron Jacobson, Md - December 16, 2020

An FDA inspection of Caron Jacobson, Md, a clinical investigator in Boston, MA, revealed two observations. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding the timing of diagnostic CT scans. Additionally, the firm failed to maintain accurate case histories, as C-Reactive Protein test results were entered into the electronic data capture system with incorrect units.