FDA 483 - ACS Dobfar SpA

An FDA inspection of ACS Dobfar SpA in Albano S.A. (BG) Italy revealed significant deficiencies in operator qualification and quality control processes. Operators performing critical in-process control testing had not been re-evaluated or re-qualified for years, and one was observed making imprecise measurements during sample preparation. Furthermore, the firm failed to initiate corrective actions for persistent operator error trends identified in 2022 and continuing into 2023, indicating a systemic issue with quality oversight.