FDA 483 - Eli Lilly and Company - September 11, 2025

Eli Lilly and Company in Pleasant Prairie, WI, was inspected and received a Form 483 with two observations related to quality control and aseptic processing. The firm failed to thoroughly investigate unexplained discrepancies and lacked adequate procedures to prevent microbiological contamination of sterile drug products. These issues indicate significant concerns regarding the firm's quality system and sterile manufacturing practices.