FDA EIR - Mead Johnson & Company, LLC - January 14, 2019

An abbreviated FDA inspection was conducted at Mead Johnson Nutrition in Zeeland, Michigan, on January 14, 2019. This directed inspection was initiated by the FDA's CORE team to investigate specific lots (ZP7EJF and ZP8GMB) of Enfamil Premium Gentlease Infant Formula for potential Clostridium botulinum contamination. This investigation was related to a broader inquiry involving another lot (EE7LHQ) manufactured at their Evansville, Indiana, facility. During the inspection, the FDA reviewed batch records and test results for the implicated lots and conducted a brief facility walkthrough. No Good Manufacturing Practice (GMP) deficiencies were observed, and an FDA Form 483, Inspectional Observations, was not issued. Furthermore, no new discussion items were conveyed to management from this inspection. Key observations included that Mead Johnson Nutrition does not directly test finished infant formula for Clostridium botulinum, relying on indirect testing for sulfite-reducing clostridia. Routine testing for Bacillus cereus and Clostridium perfringens is also not performed for infant formula destined for the U.S. market, as these are not considered "regulated organisms" by the CFR for this market. Environmental testing for C. botulinum is not conducted. Post-inspection, the firm provided requested raw material lists, which confirmed no common raw material lots between the Zeeland and Evansville facility's implicated products. No formal corrective actions were required as a result of this specific inspection.