FDA 483 - Eugia US Manufacturing LLC - December 22, 2023

Eugia US Manufacturing LLC in East Windsor, NJ, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed a dysfunctional quality control unit, inadequate aseptic processing controls, and unsuitable facility conditions. Furthermore, the firm demonstrated poor computer system controls, uninvestigated product deterioration, and scientifically unsound laboratory testing practices.