FDA EIR - Eli Lilly And Company - March 16, 2023

An FDA inspection of Eli Lilly and Company's facility at 59 Moore Dr, Durham, NC, was conducted from March 13 to March 16, 2023. This comprehensive inspection, initiated by the Center for Drug Evaluation and Research, focused on injectable delivery devices and sterile-filled small volume parenteral drugs. The inspection was performed under various regulatory frameworks, including Compliance Policy Guidance Manuals and the Guide to Inspections of Quality Systems (QSIT level 2). Inspectors assessed the firm's readiness for commercial manufacturing, conformance to application, and data integrity. Key quality subsystems reviewed included Management Controls, Design Controls, Corrective and Preventive Action (CAPA), and Production and Process Controls. Upon conclusion, no Form FDA 483, Inspectional Observations, was issued, signifying that no significant violations were identified. The inspection result was classified as "No Action Indicated" (NAI). While no specific corrective actions were mandated, management was reminded of its ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act to prevent potential future enforcement actions.