FDA 483 - Mead Johnson & Company, LLC - December 01, 2023

Mead Johnson & Company LLC in Zeeland, MI, received a Form 483 for failing to establish adequate process controls to prevent microbial adulteration of infant formula. The inspection revealed repeated Cronobacter sakazakii contamination in the processing environment, linked to insufficient cleaning after contractor work. This is a repeat observation, indicating persistent and serious issues with environmental control.