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

An FDA Establishment Inspection was conducted at Eli Lilly and Company's facility located at 59 Moore Dr, Durham, NC, from March 13 to March 16, 2023. This comprehensive inspection, guided by the Center for Drug Evaluation and Research and various Compliance Policy Guidance Manuals (CPGM) and the Guide to Inspections of Quality Systems (QSIT), focused on an Injectable Delivery Device (IDD) and sterile-filled small volume parenteral drug (SVS) manufacturing processes.

The inspection aimed to assess the firm's readiness for commercial manufacturing, conformance to its application, and data integrity. Key quality subsystems reviewed included Management Controls, Design Controls, Corrective and Preventive Action (CAPA), and Production and Process Controls, along with assembly and packaging processes.

Significantly, no Inspectional Observations (Form FDA 483) were issued at the close-out of the inspection, indicating that no deficiencies were identified. Consequently, the inspection was classified as "No Action Indicated" (NAI). Eli Lilly and Company was reminded of its ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act to avoid potential enforcement actions such as seizure, injunction, or civil/criminal penalties. No specific violations or required corrective actions resulted from this particular inspection.