Eli Lilly & Company – FDA 483, 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.
ID · 885fecd9-f6cd-48fd-90eb-66d12ec35d07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.