Eugia US Manufacturing LLCDecember 22, 2023

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

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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.

Company: Eugia US Manufacturing LLC
Inspection Date: December 22, 2023
Product Type: Drugs
Office: New Jersey District Office
People: Yoriann M. Cabrera Bartolomei
Ruben C. Quintana
Daniel L. Zheng (M.S., Consumer Safety Officer at FDA)
James R. Birkenstamm

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ID · b4c5710f-9221-4deb-b08c-7ad35c549b99