Auxilium Pharmaceuticals, Inc. – FDA 483, Jun 5, 2026

An FDA inspection of Endo USA, Inc. in Horsham, PA, an API manufacturer, revealed significant deficiencies in laboratory controls and quality unit procedures. The firm's validated test method for an API impurity assay was found to be scientifically unsound and unreliable, with a low success rate despite previous corrective actions. Additionally, the Quality Unit failed to consistently follow established procedures for validation maintenance, cleaning validations, and stability testing, indicating a systemic breakdown in quality assurance.