483
Mead Johnson & Company, LLCFDA 483 - Mead Johnson & Company, LLC - July 06, 2022
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Mead Johnson and Company LLC in Zeeland, MI, an infant formula manufacturer, received a Form 483 with two observations. The inspection revealed a failure to establish adequate process controls, specifically regarding root cause analysis for Cronobacter environmental monitoring out-of-specification results. Additionally, the firm failed to maintain its building in a clean and sanitary condition, with rust and chipping paint observed in high hygiene zones.
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