FDA 483 - ENDO USA, Inc. - June 05, 2025
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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.
ID · 47c8a26f-ab58-4b6b-b78a-4e26fd6d36c3