# FDA 483 - FreshRealm, Inc - October 20, 2025

Source: https://www.keypedia.com/records/483/freshrealm-inc/16d0dcb7-78bb-4db5-aa39-9d73f229e8ff

> FDA 483 for FreshRealm, Inc on October 20, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FreshRealm, Inc
- Inspection Date: 2025-10-20
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of FreshRealm, Inc. in Lancaster, TX, revealed a significant deficiency in their written supply-chain program. The firm failed to ensure that hazards were minimized for high-risk ingredients, specifically by not obtaining complete Certificates of Analysis and using ingredients that tested positive for Listeria monocytogenes. Additionally, non-ready-to-eat spinach was used in ready-to-eat products without proper processing, indicating a serious food safety concern.

## Related Officers

- [Vitaliy N. Guyvan](https://www.keypedia.com/people/vitaliy-n-guyvan/875994cd-30d6-432c-af4e-577056be9f67)
- [Mark T Cragen](https://www.keypedia.com/people/mark-t-cragen/13952d96-ff49-4a1a-898b-ae3a1768c908)
- [Nazira Akram](https://www.keypedia.com/people/nazira-akram/fcf65d3c-ec92-4d2e-ac0d-4f0ec6878768)
- [Cristina Alicea Matos](https://www.keypedia.com/people/cristina-alicea-matos/39c7cda2-53ce-4a0e-9737-d7328cf69998)

Company: https://www.keypedia.com/companies/freshrealm-inc/324c3d41-283c-4a89-a4e1-ed978dc7be1c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab
