FDA 483 - Daniel Norman, M.D. - October 17, 2023

The FDA inspection of Daniel Norman, M.D., Clinical Investigator, identified a critical failure in maintaining accurate and complete case histories for a clinical study involving an investigational drug. The firm failed to properly document adverse events for multiple subjects in the required system, despite these events being noted in the source records. This indicates a significant lapse in adherence to study protocol and data integrity during clinical investigations.