FDA 483 - Eli Lilly and Company - February 11, 2026

Eli Lilly and Company in Concord, NC, a sterile drug manufacturer, received a Form 483 with three observations. The inspection revealed deficiencies in process validation for drug products, inadequate validation of sterilization processes for aseptic filling equipment, and insufficient qualification of an automated visual inspection machine for particulate matter. These issues indicate a lack of robust controls to ensure drug product quality and sterility.