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

Source: https://www.keypedia.com/records/483/mead-johnson-company-llc/e52a0cfc-97f8-4f23-a847-d82e953d41fd

> FDA 483 for Mead Johnson & Company, LLC on January 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2025-01-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

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## Related Officers

- [Stephen G. Mclane](https://www.keypedia.com/people/stephen-g-mclane/1103fa08-f9ca-4ebb-99e2-86e0b1795dcf)
- [Hassan Ali](https://www.keypedia.com/people/hassan-ali/25c81f87-114f-4385-b361-b7df1d0ca638)
- [Danny Turovskiy](https://www.keypedia.com/people/danny-turovskiy/45d8db95-d749-4fb0-ba1f-c7906c5e5825)
- [CEO/CFO](https://www.keypedia.com/people/nelson-a-rodriguez/51bf64d1-1e75-4b5f-a37a-3ee9d996986b)
- [Brian J. Davis](https://www.keypedia.com/people/brian-j-davis/549057ed-e548-4747-b71f-2deb62d6b59f)

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