FDA 483 - FreshRealm, Inc - October 20, 2025
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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.
ID · 16d0dcb7-78bb-4db5-aa39-9d73f229e8ff