FDA 483 - ACS DOBFAR SPA - October 29, 2024

An FDA inspection of ACS Dobfar SpA, a sterile drug manufacturer in Castellalto, Italy, revealed deficiencies in procedures designed to prevent microbial contamination of sterile drug products. Observations included degrading gaskets on conveyor wheels and damaged identification labels on electrical wires within manufacturing areas. These findings indicate a need for improved adherence to sterile manufacturing practices.