Eli Lilly & Company – FDA EIR, May 18, 2023

An FDA "For Cause" inspection was conducted at Eli Lilly & Company's Indianapolis Device Assembly and Packaging facility from May 15 to May 18, 2023. This inspection was a directed follow-up prompted by complaints regarding Kwik-pen type products sticking or jamming. Eli Lilly & Company manufactures drug, biologic, and medical device combination products, with the inspection specifically focusing on the Kwik-pen insulin delivery system and its associated quality systems.

The regulatory review thoroughly assessed the company's corrective and preventive action (CAPA) system, complaint handling, nonconformance controls, design controls, manufacturing controls, process validations, test method validations, and supplier controls. Significantly, the inspection concluded without any formal FDA 483 Inspectional Observations being issued.

However, one discussion item was presented to management, concerning whether the firm's complaint data analysis, which primarily used the number of complaints rather than the number of affected units, accurately reflected the actual rate of device defects. While Eli Lilly & Company provided rationale for their current approach, they acknowledged the discussion point and indicated they would consider methodological changes for certain failure modes where unit count might offer a more precise representation.