FDA 483 - ENDO Pharmaceuticals Solutions, Inc. - January 17, 2025

ENDO U.S.A Inc. in Cranbury, NJ, a sterile manufacturer, was inspected by the FDA from January 7-17, 2025. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the qualification and use of reference standard Fourier Transform Infrared (FT-IR) spectroscopy data for identifying incoming materials and finished drug products. These issues indicate a failure to ensure the identity, strength, quality, and purity of components and drug products.