FDA 483 - Lumicell, Inc. - August 18, 2023

Lumicell, Inc. in Newton, MA, was inspected from August 14-18, 2023, regarding an investigational study. The inspection revealed that proper monitoring of the study was not ensured, including incomplete reports and follow-up letters for site visits. Additionally, a medical monitoring plan was not established until several months after subjects began receiving injections, indicating a significant lapse in clinical trial oversight.