483
Mead Johnson & Company, LLCMead Johnson & Company, LLC – FDA 483, Dec 1, 2023
Record Details
Mead Johnson & Company LLC in Zeeland, MI, received a Form 483 for failing to establish adequate process controls to prevent microbial adulteration of infant formula. The inspection revealed repeated Cronobacter sakazakii contamination in the processing environment, linked to insufficient cleaning after contractor work. This is a repeat observation, indicating persistent and serious issues with environmental control.
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ID · 94090418-5899-41fe-bb58-7cb10e122ee0
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