FDA 483 - Mead Johnson and Co., LLC - November 14, 2025

Between October 27 and November 14, 2025, the FDA inspected the Mead Johnson & Company, LLC facility in Wanamingo, Minnesota, which manufactures infant formula and medical foods. The inspection resulted in nine major observations regarding the safety and quality of the production environment. Key violations centered on inadequate sanitation and microbial control. Investigators found that the firm failed to validate cleaning procedures, leading to amino acid cross-contamination between different products. Furthermore, the facility reported eight positive tests for Cronobacter sakazakii but failed to follow established protocols for remediation. Water leaks and backups in hygiene zones were also poorly documented and managed. Physical contamination was a significant concern, with reports of metal shavings and plastic bag parts found in finished formula. The FDA also noted that equipment maintenance was insufficient; specifically, production lines were not properly cleaned after repairs, and the building itself had structural defects—such as ceiling joint displacements—remedied only with non-cleanable plastic shrouding and tape. Additionally, the high-hygiene production area lacked necessary handwashing facilities. These observations were recorded under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While these findings do not represent a final agency determination of non-compliance, the company is expected to respond. Mead Johnson must submit a formal response to the FDA detailing completed or planned corrective actions to ensure the facility meets safety standards for sensitive food production.