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

ENDX USA, Inc., a biological drug manufacturer in Rochester, MI, was inspected by the FDA. The inspection revealed a critical issue where procedures designed to prevent microbiological contamination of sterile drug products were not followed. This was evidenced by operators exhibiting non-compliant behaviors, such as talking and making non-deliberate hand movements, in a Grade (b) (4) manufacturing area during filling operations, indicating a potential risk to product sterility.