In November, the U.S. Food and Drug Administration (FDA) released a warning letter dated September 5, 2025, issued to Fresh and Ready Foods LLC, a firm that was implicated in a multi-state, multi-year listeriosis outbreak.

Between December 2023 and September 2024, ten people were hospitalized and one person died after consuming Listeria-contaminated ready-to-eat (RTE) foods that were produced at Fresh and Ready Foods’ San Fernando, California facility, and were sold in vending machines and breakroom areas in offices and healthcare facilities in multiple states. Cases were reported in California and Nevada. The company voluntarily recalled a range of RTE sandwiches, pastas, and snack trays in May 2025.

FDA identified the issue through environmental monitoring conducted during a site inspection, which resulted in a positive finding for Listeria monocytogenes on a piece of equipment. Whole genome sequencing (WGS) analysis confirmed that the strain of L. monocytogenes found at Fresh and Ready Foods LLC matched the outbreak strain.

The outbreak and investigation were declared over in July 2025. At the time, FDA reported that Fresh and Ready Foods had taken corrective actions, including removing equipment, to ensure ongoing food safety and compliance with FDA guidance, and that the company was working with FDA on corrective and preventive actions.

Recently, FDA released a warning letter issued on September 5 to Fresh and Ready Foods that highlighted violations observed and Listeria-positive samples collected during inspections at its San Fernando facility conducted between March 31 and April 15, 2025.

As a result of these inspections, FDA determined that the company’s RTE sandwiches, salads, wraps, and snacks were adulterated under the Federal Food, Drug, and Cosmetic Act (FFDC). The letter also asserted that, based on its inspectional findings, Fresh and Ready Foods is “neither achieving satisfactory control against the presence of L. monocytogenes within [its] facility nor implementing effective methods and controls to eliminate [L. monocytogenes] or minimize exposure to food and food-contact surfaces.”

Specific concerns listed by FDA in the warning letter include:

• Fresh and Ready Foods did not appropriately evaluate a known or reasonably foreseeable hazard to determine it required a preventive control as required by federal regulations on Hazards Analysis and Risk-Based Preventive Controls. Specifically, the firm did not consider the exposure of its RTE foods to the environment prior to packaging and the products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.
• As evidenced by Listeria-positive environmental samples, Fresh and Ready’s sanitation standard operating procedures (SSOPs) and good manufacturing practices (GMPs) are inadequate. FDA swabs at two locations tested positive for L. monocytogenes: a conveyor belt and roller where in-process RTE sandwiches were placed, and a slicer three-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.

Environmental samples from Fresh and Ready’s facility also tested positive for L. monocytogenes in 2017, at which time the firm promised FDA immediate corrective actions. Additionally, not only did swabs from 2025 test positive for the outbreak strain of L. monocytogenes, but FDA also found an L. monocytogenes isolate that is not associated with the recent outbreak, but is clustered with another clinical isolate, and is therefore capable of causing illness.

Although FDA acknowledged corrective actions Fresh and Ready Foods took in response to these findings, such as disposing of finished product and removing contaminated and hard-to-clean equipment, conducting intensified cleaning and verification swabbing, and updating its food safety plan, FDA’s warning letter underlines that the company has not yet provided:

• Additional information regarding its investigation on identifying the sources of L. monocytogenes to show that it has located and eradicated the harborage site(s), its updated food safety plan, its revised sanitation preventive control program, details regarding its revised environmental monitoring program to identify the target test microorganism, or the analytical methods it will be using
• Associated cleaning and sanitation records to reflect corrective actions
• Training records that demonstrate its employees have been trained in proper sanitation.

“Given the history of Listeria findings in [the] processing environment and most recent inspectional findings, [FDA continues] to be concerned about [the company’s] ability to maintain a sanitary environment, implement an effective sanitation preventive control, and take adequate corrective actions,” the letter says. “[FDA] would encourage [the company] to perform a comprehensive root-cause analysis to identify potential sources and routes of contamination and implement adequate corrective actions based on [the] findings.”