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

This FDA Form 483 was issued to Eli Lilly and Company, a drug product manufacturer located at Lilly Corporate Center, Indianapolis, Indiana 46285. The inspection was conducted from October 2, 2023, to October 6, 2023, by the Division of Biotechnology Manufacturing. Mr. Matt Edwards, Sr. Vice President - Indianapolis Parenteral Operations, was the recipient of the report.

The inspection revealed three observations:

1. **Procedures to prevent microbiological contamination of sterile drug products are not established or followed.** * Stopper contact surfaces are not maintained as sterile. The stopper assembly and addition of stoppers are followed by stoppering machine inability testing and removal of stoppers, with cleaning/sanitization of stopper contact surfaces, excluding certain areas. This process provides only a sanitized surface, not a sterile one. * During setup of the drug product fill line equipment on October 2, 2023, good aseptic practice was not observed. A component was mounted to the fill line, with its surface touched by sanitized gloved hands, rather than limiting handling to the designated handle. Additionally, a non-sterile gown touched a sanitized surface within the Grade A area.

2. **Validation designed to prevent microbial contamination of sterile drug products does not include adequate validation of the sterilization process.** * The sterile drug product includes a component approximately [b](4) in