# FDA 483 - Glanbia Nutritionals, Inc. - August 21, 2020

Source: https://www.globalkeysolutions.net/records/483/glanbia-nutritionals-inc/b6565237-7b96-4a28-ae35-d462d99dab44

> FDA 483 for Glanbia Nutritionals, Inc. on August 21, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glanbia Nutritionals, Inc.
- Inspection Date: 2020-08-21
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Glanbia Nutritionals Inc. in Springfield, MO, was inspected and received a Form 483 with three observations. The inspection revealed significant issues with the firm's hazard analysis and sanitation practices, particularly concerning the control of environmental pathogens like Cronobacter sakazakii in their Vivonex Pediatric Elemental Powder, a product for vulnerable infants. These deficiencies led to product contamination and inadequate preventive controls.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.globalkeysolutions.net/companies/glanbia-nutritionals-inc/17591734-8491-42e8-bff1-957ee35520d9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8