Fresh & Ready Foods, LLC
Outcome
FDA issued a warning letter on September 5, 2025, after an L. monocytogenes outbreak linked to the firm's ready-to-eat sandwiches and snack items caused 10 illnesses, 10 hospitalizations, and 1 death in California and Nevada; the firm failed to provide adequate corrective action documentation following the outbreak.
Details
Fresh & Ready Foods, LLC — Listeria / FSMA Warning Letter (2025)
Outcome: FDA issued a warning letter on September 5, 2025, citing Listeria monocytogenes contamination, FSMA preventive control violations, and inadequate corrective actions following an outbreak that killed one person and hospitalized ten others in California and Nevada.
Fresh & Ready Foods, LLC operates a ready-to-eat food manufacturing facility at 1145 Arroyo Ave, Units A-C, San Fernando, California 91340. The facility produces sandwiches, salads, wraps, snack items, and entrees distributed to vending machines, hospitals, cafeterias, and retailers in California, Nevada, Arizona, and Washington. FDA, CDC, and state partners investigated a multistate outbreak of Listeria monocytogenes occurring between December 2023 and September 2024; ten people in California and Nevada were infected, all were hospitalized, and one person died.
FDA inspected the facility from March 31 to April 15, 2025. Environmental swabs tested positive for L. monocytogenes on a conveyor belt and roller where in-process RTE sandwiches were placed, and on a slicer used to cut component ingredients for sandwiches and wraps. The firm issued a voluntary recall in May 2025 of products with Use By dates from April 22 to May 19, 2025. However, FDA's warning letter cited the firm for failing to provide updated food safety plans, revised sanitation preventive controls, cleaning and sanitation records, or employee training records in its corrective action response — violations of 21 CFR Part 117.
Notably, FDA records show that environmental samples from the same facility had tested positive for L. monocytogenes in 2017, indicating that the contamination risk had been present for nearly a decade without adequate corrective action. The September 2025 warning letter was issued through Compass Group USA, which distributes Fresh & Ready Foods products to institutional customers.
Primary Source: Compass Group USA - 709592 - 09/05/2025 | FDA Warning Letter
How Crucible Prevents This
Environmental Listeria positives were documented at this same facility as far back as 2017. The recurrence in 2023–2025 indicates a persistent sanitation gap that was never formally closed. Crucible's DECISIONS log with recurring session-gate review of open pathogen findings would have required documented resolution of the 2017 finding and establishment of a verified corrective action plan — preventing a decade of intermittent risk from culminating in a fatal outbreak.
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