FDA 483 - Ranee Mehra, M.D., Clinical Investigator - February 11, 2014

An FDA inspection of Fox Chase Cancer Center in Philadelphia revealed that an investigation was not conducted in accordance with the investigation plan. Specifically, issues were noted with patient inclusion criteria documentation, incomplete CT/MRI scan assessments, and missing ECGs for multiple patients. These deficiencies indicate a failure to adhere to study protocol and proper data collection procedures.