FDA 483 - Eli Lilly and Company - November 26, 2024

During an inspection conducted from November 18 to November 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Eli Lilly and Company's facility in Concord, NC. The inspection, which focused on device assembly and packaging, identified a significant observation related to equipment design and validation. Specifically, the FDA noted that equipment used for manufacturing, processing, packing, or holding drug products was not of appropriate design to facilitate operations for its intended use. The primary concern highlighted was that the temperature mapping verification for storage units, used for semi-finished syringes (a drug product), was found to be inadequate. The load pattern simulation used during this verification process was not representative of the firm's full load conditions, potentially impacting product quality and stability. This FDA Form 483 serves as an official communication of inspectional observations, indicating potential deviations from established quality system requirements for drug manufacturing. While not a final determination of non-compliance, it necessitates a response from Eli Lilly and Company. The company is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure all equipment is suitably designed and validated for its intended use, thereby maintaining product quality and regulatory compliance.