FDA 483 - Mead Johnson and Co., LLC - April 07, 2022

An FDA inspection of Mead Johnson and Co., LLC in Wanamingo, MN, an infant formula manufacturer, revealed a significant issue with equipment design and maintenance. Inspectors observed the use of orange tape as a temporary fix for broken gaskets on a nitrogen gassing chamber, which is not an easily cleanable surface. This condition indicates a failure to ensure equipment is of appropriate design to facilitate cleaning and maintenance.