The Food and Drug Administration inspected the food manufacturing facility of Fresh & Ready Foods LLC in San Fernando, CA, from March 31 to April 15, 2025, according to a warning letter issued Sept. 5 and made public this past week.
The firm manufactures ready-to-eat (RTE) sandwiches, salads, wraps, snack items, and entrees. The inspection was initiated as part of a multistate foodborne outbreak investigation of Listeria monocytogenes (L. monocytogenes) linked to your RTE foods.
According to the Centers for Disease Control and Prevention, as of July 24, 2025, 10 people from two states had been infected with the outbreak strain of L. monocytogenes. All 10 patients required hospitalization and one died. Both the CDC and FDA determined that products from your processing facility made the patients sick.
During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes in your facility.
At the conclusion of the inspection, FDA issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. We received your firm’s emailed responses to the FDA-483 and sample results on May 1, 2025, May 5, 2025, May 7, 2025, and May 14, 2025, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and provide detailed information describing the findings at your facility.
FDA’s most recent inspection included the collection of environmental swabs on March 31, 2025, during the production of RTE sandwiches and wraps; (redacted) of one (redacted) swabs were confirmed positive for L. monocytogenes.
This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in (redacted) environmental swabs, which included a swab collected from a direct food-contact surface taken from a mixing bowl. You promised immediate corrective actions at that time.
Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the environmental samples collected at your facility during our 2025 and 2017 inspections represent (redacted) strains of L. monocytogenes.
“The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts have been inadequate to effectively control or prevent L. monocytogenes in your facility so as to prevent contamination of food. Our findings indicate that your firm is neither achieving satisfactory control against the presence of L. monocytogenes within your facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces,” according to the warning letter.
“Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and cross-contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to apply controls or take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”
Given the history of Listeria findings in your processing environment and most recent inspectional findings, we continue to be concerned about your ability to maintain a sanitary environment, implement an effective sanitation preventive control, and take adequate corrective actions.
The complete warning letter is available here.
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