FDA EIR - Mead Johnson and Co., LLC - July 23, 2021

An FDA inspection of Mead Johnson and Co., LLC in Wanamingo, MN, was conducted from July 15-23, 2021. The inspection focused on compliance with Preventive Controls, Sanitary Human Food Operations, Infant Formula, and Medical Foods regulatory frameworks. While many previous issues from a 2019 inspection, including allergen cross-contact precautions and equipment design, were corrected, the firm's slow closure of incident reports remained an unaddressed concern. Although no FDA Form 483 was issued during the current visit, several verbal observations were made. These included facility maintenance concerns like damaged pipe wrap and a suspected roof leak, as well as hygiene issues such as employees handling primary product packaging without proper glove changes. Significant procedural deficiencies were noted in the environmental monitoring program, specifically regarding a lack of defined escalation and response timeframes for Enterobacter findings, and an instance of incorrect retesting following a Cronobacter isolation. Other observations involved incomplete sanitation records, inadequate label control procedures for allergen information, and unreviewed performance qualification reports. Firm management provided assurances that all identified issues would be corrected. The inspection concluded with the collection of infant formula and medical food samples for analysis.