FDA 483 - Eli Lilly & Company - May 20, 2025

Eli Lilly & Company in Indianapolis, IN, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in manufacturing process controls, including inadequate automated visual inspection qualification and aseptic processing validation. Other issues included a failure to validate supplier test results for critical components, insufficient cleaning and maintenance procedures, and incomplete quality control unit procedures regarding complaint investigations.