FDA 483 - Eli Lilly & Company - October 17, 2022

Eli Lilly and Company in Indianapolis, Indiana, received three observations during an FDA inspection concerning deficiencies in their manufacturing processes. The observations highlight issues with aseptic technique during drug product filling operations, including improper handling of sterile components and inadequate sanitization practices. Additionally, the firm's disinfection efficacy study was found to be insufficient in supporting observed sanitization procedures.