FDA 483 - Aldeyra Therapeutics, Inc. - April 28, 2023

An FDA inspection of Aldeyra Therapeutics, Inc. in Lexington, MA, a sponsor of clinical studies, revealed a significant failure in ensuring proper monitoring of a study. Specifically, the monitor failed to identify multiple discrepancies where Multi-Symptom Visual Analog Scale (VAS) scores were incorrectly measured and reported in the electronic data capture system for several subjects. This indicates issues with data integrity and oversight in their clinical trial processes.