483
Eli Lilly and CompanyEli Lilly and Company – FDA 483, Sep 11, 2025
Record Details
Eli Lilly and Company in Pleasant Prairie, WI, was inspected and received a Form 483 with two observations related to quality control and aseptic processing. The firm failed to thoroughly investigate unexplained discrepancies and lacked adequate procedures to prevent microbiological contamination of sterile drug products. These issues indicate significant concerns regarding the firm's quality system and sterile manufacturing practices.
View Company Profile
ID · f9031c95-8ad0-4123-b05c-2737507e5cf4
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.