FDA 483 - Mead Johnson and Co., LLC - January 09, 2023

An FDA inspection of Mead Johnson and Co., LLC in Wanamingo, MN, revealed significant deficiencies in their infant formula manufacturing processes. The firm failed to implement adequate process controls to prevent Cronobacter sakazakii contamination, leading to positive product and environmental samples without proper investigation. Additionally, issues were identified with personnel hygiene practices and the maintenance and sanitation of equipment and surfaces, increasing the risk of product adulteration.