FDA 483 - Ascendis Pharma LLC - March 06, 2026

From March 3 to March 6, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of Ascendis Pharma LLC at its facility in Palo Alto, California. The inspection, which focused on the firm"s post-marketing adverse drug experience (PADE) reporting protocols, identified two primary safety reporting violations. First, the company failed to report serious and unexpected adverse experiences within the required 15-day expedited timeframe. A specific instance involved a report of a patient hospitalized after using Yorvipath; although the case contained sufficient clinical detail to be considered valid, the company dismissed it and three other social media-sourced reports without proper medical review. Second, the FDA found that Ascendis Pharma lacked formalized written procedures for the systematic surveillance and reporting of adverse experiences discovered via social media for its products, SKYTROFA and YORVIPATH. These observations were issued under the Federal Food, Drug, and Cosmetic Act to ensure the firm maintains adequate oversight of patient safety. While these findings do not constitute a final agency determination, the company is expected to respond with a corrective action plan or documentation addressing these deficiencies to ensure future compliance with safety monitoring standards.