FDA 483 - FreshRealm, Inc - October 20, 2025

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.