FDA 483 - Waylis Therapeutics - February 12, 2026

Waylis Therapeutics LLC in Rahway, NJ, was inspected by the FDA, revealing a significant deficiency in their post-marketing surveillance procedures. The firm lacked written procedures for monitoring and reconciling adverse drug experiences, especially those reported through their patient access and affordability programs for most of their products. This indicates a failure to establish proper processes for handling critical safety information.