FDA 483 - Eli Lilly & Company - October 06, 2023

Eli Lilly and Company in Indianapolis, Indiana, received a Form 483 with three observations related to sterile drug product manufacturing. The observations highlight deficiencies in preventing microbiological contamination, inadequate sterilization process validation, and an unoptimized drug product fill process leading to encrustation. These issues indicate significant concerns regarding aseptic processing and product quality control.