FDA 483 - Charu Aggarwal, MD, MPH, Hematology-Oncology Division - March 28, 2017

An FDA inspection of Charu Aggarwal, MD, MPH, Hematology-Oncology Division in Philadelphia, PA, revealed significant deficiencies in the conduct of a clinical investigation. The principal investigator and staff failed to adhere to the study protocol, lacked adequate oversight, and maintained inadequate and inaccurate case histories. These issues indicate serious non-compliance with clinical trial regulations.