Eli Lilly Italia SPA – FDA 483, Feb 10, 2023

Eli Lilly Italia S.p.A. in Sesto Fiorentino, Italy, was issued a Form FDA 483 with two observations following an inspection from February 2-10, 2023. The inspection revealed issues with equipment design leading to black particle generation and a lack of comprehensive quality risk assessment. Additionally, the firm failed to establish or follow adequate written procedures for production and process controls, impacting aseptic process simulation, revalidation, system qualification, filter drying, and equipment maintenance, raising significant concerns about product quality and control.