FDA 483 - Mead Johnson and Co., LLC - May 31, 2019

An FDA inspection of Maple Island, Inc. in Wanamingo, MN, an infant formula/medical food/food manufacturer, revealed three observations. These included inadequate precautions against allergen cross-contact and contamination during production, failure to maintain a history of recertification for equipment, and issues with equipment design and maintenance leading to potential contamination.