# FDA 483 - Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. - July 22, 2022

Source: https://www.globalkeysolutions.net/records/483/mead-johnson-nutricionales-de-mexico-s-de-rl-de-cv/5e694e28-44c8-4770-824d-e370914c8f1a

> FDA 483 for Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V. on July 22, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mead Johnson Nutricionales de Mexico, S. de R.L. de C.V.
- Inspection Date: 2022-07-22
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Mead Johnson & Company, an infant formula manufacturer in Ciudad Delicias, Mexico, revealed a significant lapse in temperature monitoring for thermal processing equipment. Specifically, the firm failed to adequately monitor and document HTST pasteurizer temperatures, a critical control point for infant formula base preparation. This indicates a potential risk to product quality and safety due to inadequate process control.

## Related Officers

- [Rene M Arangua](https://www.globalkeysolutions.net/people/rene-m-arangua/6340dadc-e7ce-4441-beaa-f47d4666859f)
- [investigator](https://www.globalkeysolutions.net/people/richard-g-fochesato/0d802787-3bc0-43bc-a1dc-90dee648290b)
- [Kibily D. Dembele](https://www.globalkeysolutions.net/people/kibily-d-dembele/50512b91-e9d9-4b83-affc-da9bfef2df16)

Company: https://www.globalkeysolutions.net/companies/mead-johnson-nutricionales-de-mexico-s-de-rl-de-cv/7ad52e7b-f861-4932-8402-1daa67dbaf98

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1