483
ACS DOBFAR SPAACS DOBFAR SPA – FDA 483, Oct 29, 2024
Record Details
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.
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ID · ea51aa34-127c-4143-906e-6aca74b897f0
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