FDA 483 - Sanofi S.r.l. - May 22, 2023

During an inspection from May 12-22, 2023, Sanofi S.p.A in Anagni, Italy, was cited for significant deficiencies in its aseptic processing procedures and aseptic process simulations. The firm failed to establish and follow procedures to prevent microbiological contamination of sterile drug products and conducted simulations that did not fully represent actual manufacturing conditions. These issues indicate a risk to the sterility and quality of drug products.