FDA 483 - MABXIENCE S.A.U. - April 07, 2025

The FDA inspection of mAbxience S.A.U. in Garin, Argentina, revealed significant deficiencies in its drug substance manufacturing operations. The firm failed to optimize its manufacturing processes, leading to bioburden control issues, and exhibited inadequately maintained facilities and equipment. Furthermore, the inspection identified shortcomings in environmental control, validation activities, adherence to standard operating procedures, and laboratory controls, indicating a broad lack of control over critical quality systems.