# FDA 483 - Mead Johnson & Company, LLC - October 20, 2023

Source: https://www.keypedia.com/records/483/mead-johnson-company-llc/fc533774-5c9d-4fa6-9165-0ac256f1e4e2

> FDA 483 for Mead Johnson & Company, LLC on October 20, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2023-10-20
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspection of Mead Johnson & Company LLC in Zeeland, MI, revealed significant deficiencies in their infant formula manufacturing processes. The firm failed to establish adequate process controls to prevent microbial contamination, leading to Cronobacter sakazakii positive products and environmental samples. Additionally, issues were noted with equipment design not facilitating proper cleaning and maintenance, and a general failure to regularly clean, sanitize, and maintain equipment.

## Related Documents

- [483 - 2025-12-07](https://www.keypedia.com/records/483/mead-johnson-company-llc/5de80e8c-0370-4d00-be76-f3f03b2eae75)
- [483 - 2025-01-10](https://www.keypedia.com/records/483/mead-johnson-company-llc/90ce374f-b9fd-4db0-9715-a756cb58da5f)
- [483 - 2022-07-06](https://www.keypedia.com/records/483/mead-johnson-company-llc/a36be431-a173-46a8-bab0-42dcdc31f3cf)
- [483 - 2024-01-10](https://www.keypedia.com/records/483/mead-johnson-company-llc/aba0312c-fa93-493c-9065-f77850f61f84)
- [483 - 2023-12-01](https://www.keypedia.com/records/483/mead-johnson-company-llc/94090418-5899-41fe-bb58-7cb10e122ee0)

## Related Officers

- [Chase S. Baldwin](https://www.keypedia.com/people/chase-s-baldwin/0fe03d57-1eeb-4e0e-b417-c926f4bb216e)
- [Emily E. Krumel](https://www.keypedia.com/people/emily-e-krumel/21f9f34a-0535-4e31-84cb-f3331d2f8cdd)
- [issuing_officer](https://www.keypedia.com/people/evan-m-kupper/3705892a-1bbc-49ad-a39e-e2c78ae181ce)
- [Hassan M. Fakhreddine](https://www.keypedia.com/people/hassan-m-fakhreddine/4c94cc1c-ea8d-42f8-a4b3-d7858569c1ff)
- [issuing_officer](https://www.keypedia.com/people/logan-m-ebeling/546c6a0d-664e-4189-b02b-2f8c1c05a640)

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