FDA 483 - ENDO USA, Inc. - October 20, 2025

An FDA inspection of ENDO USA, Inc. in Rochester, MI, a sterile drug manufacturer, revealed significant deficiencies in its manufacturing operations. Observations included inadequately designed equipment leading to aseptic breaches, failures in preventing microbiological contamination through deficient aseptic process simulations and environmental monitoring, and a visual inspection program that could not consistently detect product defects. The firm also failed to thoroughly review unexplained discrepancies, impacting product quality and patient safety.