FDA 483 - Medtronic, Inc. - December 10, 2025

Between December 8 and December 10, 2025, the FDA conducted an inspection of the Medtronic, Inc. manufacturing facility in Minneapolis, Minnesota. The inspection resulted in the issuance of a Form 483 identifying two primary areas of concern regarding the production and quality control of combination drug products. The first major issue involves inadequate laboratory testing to ensure products are sterile and free from contaminants. Specifically, the firm failed to test every batch of certain products for bacterial toxins. Furthermore, sterility testing was performed on a placebo rather than the actual drug product, and the firm failed to use all required growth media types mandated by standard industry testing protocols. The second violation concerns the oversight of raw material suppliers. Medtronic did not sufficiently validate the analytical reports provided by component suppliers, omitting required tests for certain impurities without documented justification. These observations were documented under Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While these findings are not a final agency determination of non-compliance, Medtronic is expected to respond by either contesting the observations or submitting a detailed plan for corrective actions to address these deficiencies in their quality systems and laboratory practices.