FDA 483 - Mead Johnson and Co., LLC - January 10, 2024

Mead Johnson and Co., LLC in Wanamingo, MN, received a Form 483 with three observations related to infant formula manufacturing. The inspection revealed significant issues with process controls, including repeated Cronobacter species findings in high hygiene areas, inadequate environmental monitoring, and failure to follow water leak and deviation procedures. Additionally, the firm was cited for insufficient qualified personnel and failure to ensure proper cleaning and sanitization of food-contact and non-food-contact surfaces, with several repeat observations from previous inspections.