Eli Lilly and Company – FDA 483, Feb 11, 2026

Eli Lilly and Company in Concord, NC, a sterile drug manufacturer, received a Form 483 with three observations during an FDA inspection. The firm was cited for failing to establish adequate written procedures for process validation across all drug product strengths and for lacking proper validation of aseptic and sterilization processes. Additionally, the firm did not adequately qualify an automated visual inspection machine used for in-process controls, indicating significant deficiencies in their manufacturing and quality control systems.