FDA 483 - Amanda L. Cox, MD - May 10, 2024

An FDA inspection of Mount Sinai Kravis Children's Hospital identified a significant issue in a clinical investigation involving children. The principal investigator failed to consistently obtain permission from both parents for enrolled subjects, which is a requirement per institutional review board approval and for the COVID-19 addendum to informed consent forms. This indicates a critical lapse in ensuring proper informed consent for pediatric participants.