FDA 483 - Elizabeth Plimack, MD, MS - September 26, 2019

An FDA inspection of Elizabeth Plimack, MD, MS in Philadelphia, PA, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. This included failures to submit tumor tissue for biomarker analysis, collect various blood specimens, and perform electrocardiograms for multiple study subjects as required by the protocol. These deviations indicate a significant lack of adherence to the established investigational plan.