FDA 483 - Mead Johnson & Company, LLC - October 20, 2023

The FDA inspection of Mead Johnson & Company LLC in Zeeland, MI, revealed significant deficiencies in their infant formula manufacturing processes. The firm failed to establish adequate process controls to prevent microbial contamination, leading to Cronobacter sakazakii positive products and environmental samples. Additionally, issues were noted with equipment design not facilitating proper cleaning and maintenance, and a general failure to regularly clean, sanitize, and maintain equipment.