Eli Lilly & Company – FDA 483, Jun 16, 2023

An FDA inspection of Eli Lilly and Company's drug product manufacturing facility in Indianapolis, Indiana, revealed three observations. Deficiencies included failure to follow sanitization procedures for equipment in critical areas, inadequate laboratory practices for test sample traceability, and insufficient validation of sterilization equipment. These issues highlight concerns with adherence to established procedures and validation protocols critical for drug product quality and purity.