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

Jonathan E. Issacs, M.D. in Richmond, VA, received an FDA Form 483 following an inspection from February 24-28, 2025. The inspection revealed two significant issues related to clinical trial conduct. Observations included a failure to provide temperature logs for an investigational product and a delay in reporting a serious adverse event to the sponsor.