Mead Johnson & Company, LLCJanuary 10, 2025

FDA 483 - Mead Johnson & Company, LLC - January 10, 2025

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An FDA inspection of Mead Johnson & Company, LLC in Zeeland, MI, from November 2024 to January 2025, revealed a repeat observation regarding the firm's failure to establish adequate process controls for infant formula manufacturing. The facility showed significant environmental contamination, with multiple swabs testing positive for Cronobacter spp. in high hygiene areas and observed water pooling, indicating a serious risk of product adulteration.

Company: Mead Johnson & Company, LLC
Inspection Date: January 10, 2025
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations III
People: Stephen G. Mclane
Hassan Ali
Danny Turovskiy
Nelson A. Rodriguez (CEO/CFO)
Brian J. Davis

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ID · e52a0cfc-97f8-4f23-a847-d82e953d41fd