Mead Johnson & Company, LLCDecember 1, 2023

FDA 483 - Mead Johnson & Company, LLC - December 01, 2023

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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.

Company: Mead Johnson & Company, LLC
Inspection Date: December 1, 2023
Product Type: Other
Office: Division of Pharmaceutical Quality Operations III
People: Tamayo C. Barnes (Microbiology)
David M. Amy
Christi L. Bellmore (Supervisory Wildlife Inspector, Agriculture Specialist, Animal Health Technician)
Jacob Nwachukwu
Bing Lin (Consumer Safety Officer/Investigator)

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ID · 94090418-5899-41fe-bb58-7cb10e122ee0