# FDA 483 - Mead Johnson and Co., LLC - January 30, 2025

Source: https://www.keypedia.com/records/483/mead-johnson-and-co-llc/32322b34-b2aa-4f3b-ae33-8720f8aa9c70

> FDA 483 for Mead Johnson and Co., LLC on January 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson and Co., LLC
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Mead Johnson & Company, LLC in Wanamingo, MN, was inspected and cited for significant deficiencies in process controls, sanitation, and personnel qualifications related to infant formula manufacturing. The inspection revealed repeat observations concerning microbial contamination risks, inadequate cleaning validation leading to product carryover, and insufficient controls for preventing foreign material contamination. These issues indicate a moderate to severe level of non-compliance impacting product quality and safety.

## Related Documents

- [483 - 2019-05-31](https://www.keypedia.com/records/483/mead-johnson-and-co-llc/75b6a556-204f-4810-b422-0d7dc6d42376)
- [EIR - 2021-07-23](https://www.keypedia.com/records/eir/mead-johnson-and-co-llc/a1d3792d-b586-45f9-9cc6-0e354b04f0d0)
- [483 - 2022-04-07](https://www.keypedia.com/records/483/mead-johnson-and-co-llc/61c40cd5-7219-45b5-8af4-ccc5af768218)
- [483 - 2023-01-09](https://www.keypedia.com/records/483/mead-johnson-and-co-llc/6ba7c3a4-d1ea-4ed3-b53f-bab301c50dfa)
- [483 - 2024-01-10](https://www.keypedia.com/records/483/mead-johnson-and-co-llc/e5e698c7-106e-4376-a81a-0c0edff072ed)

## Related Officers

- [Consumer Safety Officer/Investigator](https://www.keypedia.com/people/bing-lin/7037e34a-15df-4e81-bd35-bd91b9ab167a)
- [Elizabeth P. Mayer](https://www.keypedia.com/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)

Company: https://www.keypedia.com/companies/mead-johnson-and-co-llc/a2fd5250-46e4-4ba7-8db0-2a4db3d32372

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d