# FDA 483 - Mead Johnson & Company, LLC - August 26, 2021

Source: https://www.keypedia.com/records/483/mead-johnson-company-llc/dd17fedc-2f7d-4c4e-a567-bdf541396176

> FDA 483 for Mead Johnson & Company, LLC on August 26, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson & Company, LLC
- Inspection Date: 2021-08-26
- Product Type: other
- Office Name: Chicago District Office
- Summary: Mead Johnson Nutrition, an infant formula manufacturer in Evansville, IN, received a Form 483 with three observations. The inspection revealed issues with the accurate and easy readability of temperature-indicating devices, inadequate record-keeping for critical factors in the scheduled process, and insufficient frequency of recording operating conditions to ensure commercial sterility. These findings highlight deficiencies in process control and documentation for infant formula production.

## Related Documents

- [EIR - 2015-08-21](https://www.keypedia.com/records/eir/mead-johnson-company-llc/caed12c1-5ecf-4b7d-b7d4-d304d6aaada7)
- [EIR - 2021-08-26](https://www.keypedia.com/records/eir/mead-johnson-company-llc/e6120b19-1bcd-4d43-9281-f072674b62ca)

## Related Officers

- [Elizabeth P. Mayer](https://www.keypedia.com/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)
- [Investigator](https://www.keypedia.com/people/daniel-b-arrecis/d418d5a0-aa4c-4408-9f73-3fe668d97cdd)

Company: https://www.keypedia.com/companies/mead-johnson-company-llc/dc12f814-07fa-44a7-acf5-2a858f28dd53

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