FDA 483 - Jonathan E. Isaacs, M.D. - February 28, 2025

Jonathan E. Isaacs, M.D., a clinical investigator in Richmond, VA, was cited with two observations during an FDA inspection. The firm failed to provide complete temperature logs for an investigational product throughout a clinical trial, hindering record verification. Additionally, a serious adverse event was not reported promptly to the sponsor, exceeding the protocol-specified timeframe.