# FDA 483 - Mead Johnson & Company, LLC - July 06, 2022

Source: https://www.keypedia.com/records/483/mead-johnson-company-llc/a36be431-a173-46a8-bab0-42dcdc31f3cf

> FDA 483 for Mead Johnson & Company, LLC on July 06, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2022-07-06
- Product Type: other
- Office Name: Chicago District Office
- Summary: 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.

## Related Documents

- [483 - 2025-12-07](https://www.keypedia.com/records/483/mead-johnson-company-llc/5de80e8c-0370-4d00-be76-f3f03b2eae75)
- [483 - 2023-10-20](https://www.keypedia.com/records/483/mead-johnson-company-llc/fc533774-5c9d-4fa6-9165-0ac256f1e4e2)
- [483 - 2025-01-10](https://www.keypedia.com/records/483/mead-johnson-company-llc/90ce374f-b9fd-4db0-9715-a756cb58da5f)
- [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

- [Brittany A. Mckenzie](https://www.keypedia.com/people/brittany-a-mckenzie/4f504ac7-a258-4144-b14c-19d9d139a549)
- [Investigator](https://www.keypedia.com/people/daniel-b-arrecis/d418d5a0-aa4c-4408-9f73-3fe668d97cdd)

Company: https://www.keypedia.com/companies/mead-johnson-company-llc/ce8174b8-a793-423e-a864-edaf39f12a80

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669