FDA 483 - ENDO USA, Inc. - June 05, 2025

An FDA inspection of ENDO USA, Inc. in Rochester, MI, a biological drug manufacturer, revealed a significant issue with aseptic processing. Procedures designed to prevent microbiological contamination of sterile drug products were not followed. Specifically, operators were observed talking and moving hands in a fast, non-deliberate motion in Grade (b) (4) manufacturing areas during filling operations, indicating a breakdown in aseptic technique.