FDA 483 - Mead Johnson & Company, LLC - December 07, 2025

Mead Johnson & Company, LLC in Zeeland, MI, received a Form 483 for failing to establish adequate process controls to prevent infant formula adulteration from microorganisms. This is a repeat observation, with FDA swabs repeatedly testing positive for Cronobacter spp. in high hygiene areas of the dryer room, and pooling water observed on the floor. These conditions indicate significant microbiological control issues within the facility.