FDA 483 - Unknown Company - February 12, 2026

Between February 9 and February 12, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of the corporate headquarters of Waylis Therapeutics LLC in Rahway, New Jersey. The inspection identified a critical gap in the company"s safety monitoring systems regarding post-marketing oversight. Specifically, the FDA observed that Waylis Therapeutics has failed to develop and implement written procedures for the surveillance of adverse drug experiences. Although the company manages Patient Access and Affordability Programs for 14 of its 15 products, it lacks formal protocols for monitoring, reporting, or reconciling side effects and health complaints received through these specific patient-facing programs. This deficiency suggests that potential safety signals may not be effectively captured or analyzed. These observations were recorded under the regulatory authority of the Federal Food, Drug, and Cosmetic Act. While this Form 483 represents the investigator"s findings and not a final agency determination of non-compliance, Waylis Therapeutics is expected to address these concerns. The company must implement corrective actions, such as establishing robust surveillance and reconciliation procedures for all patient programs, and is encouraged to submit a formal response to the FDA detailing their plan to resolve these procedural issues.