FDA 483 - Mead Johnson & Company, LLC - January 10, 2024

Mead Johnson & Company, LLC, an infant formula manufacturer in Zeeland, MI, was cited for failing to conduct operations under conditions and controls necessary to minimize the potential for food contamination. An employee was observed manually adding an ingredient by placing a bag directly onto a blender chute grate that had existing powder, which violated the firm's own work instructions. This indicates a significant lapse in contamination control during the manufacturing process.