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

Source: https://www.keypedia.com/records/483/mead-johnson-company-llc/94090418-5899-41fe-bb58-7cb10e122ee0

> FDA 483 for Mead Johnson & Company, LLC on December 01, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2023-12-01
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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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Company: https://www.keypedia.com/companies/mead-johnson-company-llc/ce8174b8-a793-423e-a864-edaf39f12a80

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0