FDA EIR - Eli Lilly And Company - January 13, 2022

An FDA inspection of Eli Lilly and Company was conducted from January 4 to January 13, 2022. This high-priority surveillance inspection, overseen by the CDER Office of Scientific Investigations, aligned with Compliance Program 7348.810 for Sponsors and Contract Research Organizations. The inspection primarily focused on the company's New Drug Application (NDA 215866) for Tirzepatide (MOUNJARO), a medication for type 2 diabetes, reviewing three pivotal clinical trial protocols (SURPASS 2, 3, and 5) across multiple investigator sites. While no formal FDA Form 483 (Inspectional Observations) was issued, the inspection concluded with a "Voluntary Action Indicated" (VAI) classification. Key findings discussed with the firm included the ineffective validation of the Interactive Web Response System (IWRS) used in the Tirzepatide studies, which presented potential risks to subject safety and data integrity. Additionally, inadequate monitoring practices were identified at one clinical site, specifically concerning the review of subjects' medical history records. It was also noted that two study sites failed to provide necessary local laboratory certifications during the COVID-19 period. The VAI classification signifies that Eli Lilly is expected to undertake voluntary corrective actions to address these identified deficiencies and ensure ongoing compliance with regulatory standards.