FDA 483 - Mead Johnson and Co., LLC - January 30, 2025

Mead Johnson & Company, LLC in Wanamingo, MN, was inspected and cited for significant deficiencies in process controls, sanitation, and personnel qualifications related to infant formula manufacturing. The inspection revealed repeat observations concerning microbial contamination risks, inadequate cleaning validation leading to product carryover, and insufficient controls for preventing foreign material contamination. These issues indicate a moderate to severe level of non-compliance impacting product quality and safety.