Eli Lilly & Company – FDA EIR, Oct 21, 2022

An FDA pre-license inspection of Eli Lilly & Company's Indianapolis facility took place from October 17 to October 21, 2022. This inspection supported specific drug product applications and was conducted under the regulatory framework of CPGM 7346.832 (Preapproval Inspections) and ICH Q7, scrutinizing areas such as Quality, Facilities, Production, Materials, Laboratory Control, and Packaging/Labeling systems. The inspection identified three main violations, leading to the issuance of an FDA Form 483. These included deficient aseptic technique during drug product filling operations. Furthermore, the facility's aseptic processing areas, specifically the Vial Filling and other filling lines, were found to have inadequate processes for personnel monitoring following critical Restricted Access Barrier System (RABS) activities. The third observation highlighted that the company's disinfectant efficacy study did not adequately support the sanitization procedures observed during the setup and production of drug product filling operations. The inspection concluded with an "Official Action Indicated" (OAI) classification, signifying that significant regulatory action is warranted. Eli Lilly & Company is now required to provide a response and implement comprehensive corrective actions to address these critical observations, ensuring adherence to good manufacturing practices for their pharmaceutical products.