FDA 483 - Mead Johnson & Company, LLC - July 06, 2022

Mead Johnson and Company LLC in Zeeland, MI, an infant formula manufacturer, received a Form 483 with two observations. The inspection revealed a failure to establish adequate process controls, specifically regarding root cause analysis for Cronobacter environmental monitoring out-of-specification results. Additionally, the firm failed to maintain its building in a clean and sanitary condition, with rust and chipping paint observed in high hygiene zones.