Fresh & Ready given FDA Warning Letter after 10 Hospitalized with 1 Death due to Listeria

A total of 10 people infected with the outbreak strain of Listeria were reported from two states. Sick people’s samples were collected from December 3, 2023, to September 9, 2024. Of the 10 people with information available, all 10 were hospitalized. One death was reported from Nevada.

Here is the Warning Letter in full:

September 5, 2025

WARNING LETTER

CMS #709592

Dear Mr. Lonc:

The United States Food and Drug Administration (FDA) inspected your food manufacturing facility, Fresh & Ready Foods LLC, located at 1145 Arroyo Ave, Units A-C, San Fernando, CA 91340, from March 31 to April 15, 2025. Your 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 (CDC), as of July 24, 2025, ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes. On May 10, 2025, your firm recalled RTE foods, including sandwiches and snack items, with “Use By” dates from 4/22/2025 to 05/19/2025 because they had the potential to be contaminated with L. monocytogenes.

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 (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Additionally, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.

Based on FDA’s inspectional findings and analytical results for samples collected from your production environment, we have determined that your RTE sandwiches, salads, wraps, and snacks are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at www.fda.gov.

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. We discuss your responses below.

Multiyear Multistate Outbreak of Listeria monocytogenes Linked to RTE Foods

The FDA, along with CDC and state and local partners, investigated a multiyear, multistate outbreak of L. monocytogenes linked to RTE sandwiches and snack items manufactured by Fresh & Ready Foods, LLC. According to the CDC, as of July 24, 2025, ten (10) people from two (2) states (California and Nevada) have been infected with the outbreak strain of L. monocytogenes. Specimen collection dates range from December 3, 2023, to September 9, 2024. Among the ten (10) people with available information, all were hospitalized and there was one death attributed to listeriosis. Whole Genome Sequencing (WGS) performed on the clinical isolates from the cases in California and Nevada revealed that the clinical isolates match two (2) environmental swabs taken from your production area during the recent FDA inspection of your facility conducted from March 31 to April 15, 2025.

FDA and CDC have determined, based upon the epidemiologic, traceback evidence, and WGS analysis, that RTE foods produced by Fresh & Ready Foods LLC are the likely source of this outbreak. On May 10, 2025, your firm recalled RTE foods, including sandwiches and snack items, with “Use By” dates from 4/22/2025 to 05/19/2025 because they had the potential to be contaminated with L. monocytogenes.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not appropriately evaluate a known or reasonably foreseeable hazard to determine it required a preventive control in your RTE sandwiches, salads, wraps, snacks, and entrees products, as required by 21 CFR 117.130(a)(1). Specifically:

a. Your facility processes refrigerated RTE sandwiches, salads, wraps, snacks, and entrees products that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as L. monocytogenes. You did not appropriately evaluate contamination with environmental pathogens, such as L. monocytogenes, to determine whether it is a hazard requiring a preventive control in your RTE products. Your facility’s written hazard analysis considered biological pathogens such as L. monocytogenes at the RTE product preparation, assembly, and (b)(4) steps but you determined this hazard was not reasonably likely to occur and did not require a preventive control due to your Sanitation Standard Operational Procedures (SSOPs) and Good Manufacturing Procedures (GMPs). However, your RTE products are exposed to the environment prior to packaging and 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. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)). Furthermore, as evidenced by the following analytical results, your SSOPs and GMPs are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of environmental pathogens such as L. monocytogenes, as required by 21 CFR 117.135(c)(3).

Listeria monocytogenes in your facility:
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without adequate controls, it can proliferate in food processing facilities and subsequently contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive, and to apply controls or take corrective actions, as necessary, to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

FDA’s most recent inspection included the collection of environmental swabs on March 31, 2025, during the production of RTE sandwiches and wraps; (b)(4) of one (b)(4) swabs were confirmed positive for L. monocytogenes. The positive findings included the food-contact surfaces of a:

– Conveyor belt and roller where in-process RTE sandwiches were placed.
– Slicer 3-gauge plate/knife cover which is used to slice component ingredients for RTE sandwich and wrap products.

This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in (b)(4) 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 (b)(4) strains of L. monocytogenes, including:

i. (b)(4) of these strains included isolates obtained from (b)(4) environmental swabs collected in 2025 which clustered with ten (10) clinical isolates belonging to the outbreak strain, and (b)(4) other food and environmental [historical/older] isolates, which indicates that this strain of L. monocytogenes is capable of causing illness. 

ii. The second (b)(4) included isolates obtained from (b)(4) environmental swabs collected in 2025 that clustered with (b)(4) clinical isolate, not associated with the above referenced outbreak and (b)(4) other food and environmental isolates. This indicates that this strain of L. monocytogenes is also capable of causing illness.

iii. The third (b)(4) included isolates obtained from (b)(4) environmental swabs collected in 2017 that clustered with (b)(4) other environmental isolates.

We advised you of these WGS results, our inspectional findings, and the outbreak investigation during calls held on April 24, 2025, May 6, 2025, and May 9, 2025. On May 10, 2025, your firm voluntarily recalled all RTE FDA-regulated food products with “Use By” dates from 4/22/2025 to 05/19/2025 due to potential contamination with 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. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. 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. 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.

We acknowledge the corrective actions you have taken in response to these findings. In response to our April 11, 2025, notification about the L. monocytogenes detection in (b)(4)environmental swabs, your firm disposed of finished product manufactured on Line (b)(4)and Slicer (b)(4), and removed and isolated the equipment from the production environment. Additionally, on April 11, 2025, you conducted intensified cleaning of your equipment and production room and conducted verification swabbing which did not detect L. monocytogenes. Further, in response to the issued FDA-483, you indicate that you updated your food safety plan to identify the hazard of recontamination with environmental pathogens at the (b)(4) step, you ceased production on April 26, 2025, conducted a full facility cleaning and sanitation on April 26 through April 28, 2025, conducted environmental swabbing, and retained a third-party consultant on May 5, 2025 to review your facility’s sanitation processes. Additionally, you assessed the cleanability of equipment and removed conveyor belts which were deemed difficult to clean between April 11 and May 3, 2025, and you expanded the use of cleaning and sanitation chemicals following training from your sanitation chemical provider.

However, you have not provided any additional information regarding your investigation on identifying the sources of L. monocytogenes to show that you have located and eradicated the harborage site(s), your updated food safety plan, your revised sanitation preventive control program, details regarding your revised environmental monitoring program to identify the target test microorganism, and the analytical methods you will be using. You also did not provide any of your associated cleaning and sanitation records to reflect your corrective actions, and you did not provide any training records that demonstrate your employees have been trained in proper sanitation.

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. We would encourage you to perform a comprehensive root-cause analysis to identify potential sources and routes of contamination and implement adequate corrective actions based on your findings. Furthermore, we encourage you continue to identify potential harborage sites in your processing environment and implement the necessary methods and controls to ensure L. monocytogenes does not contaminate your environment or your RTE food products. You should implement and monitor your sanitation preventive control and verify it is working through a robust environmental monitoring program with associated aggressive corrective actions when Listeria is found in your facility environment. We remind you that environmental sampling is most effective at identifying pathogens when extensive sampling occurs several hours into production, because production activities may dislodge pathogens from harborage sites. You should continue to implement the necessary methods and controls to ensure foodborne pathogens do not contaminate your environment or your RTE food products. Your record keeping will be critical to demonstrate your implementation of these corrective actions consistently over time. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.

b. You did not appropriately evaluate physical hazards such as metal, to determine whether it is a hazard requiring a preventive control in your RTE products. Your hazard analysis for sandwiches, vegetarian wraps, vegetarian salads, vegetarian snacks, and nonmeat entrees considered the physical hazard of metal at the RTE products preparation and (b)(4) steps and determined it was not a hazard reasonably likely to occur because you have a pre-requisite GMP program. You perform visual inspections of metal surfaces and utensils and conduct periodic metal detector checks for lines with metal detectors during operations.

You did not have adequate controls in place, as evidenced by missing metal lacing segments observed on Lines (b)(4) conveyor belts on March 31, 2025. Further, product manufactured on Line (b)(4) did not pass through a metal detector. Missing metal lacing segments is a repeat observation from our previous inspection of your facility.

We acknowledge your May 1, 2025, response states you purchased additional metal detectors in September 2024 (prior to the recent inspection) and plan to place metal detectors at the end of every conveyor belt, beginning with conveyor belts with metal lacings. However, your response does not indicate whether you will identify the physical hazard of metal as requiring a preventive control and establish and implement a preventive control program to control this hazard. We will assess the adequacy of your corrective actions during our next inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comments:

• You did not appropriately evaluate the hazard of biological pathogens associated with your ingredients as a known or reasonably foreseeable hazard requiring a preventive control, although you have a vendor approval program for ingredients. Your facility produces ready-to-eat products containing ingredients with reasonably foreseeable biological hazards (specifically, chilled RTE produce) that do not undergo a validated (b)(4) step or other adequate lethality treatment within your facility to eliminate these identified hazards. Therefore, for those ingredients, you are required to establish and implement a supply chain program to comply with 21 CFR 117.405(a)(1). This requirement includes verifying that your suppliers maintain appropriate controls for these biological hazards and maintaining adequate documentation to demonstrate such supplier verification activities.
• Non-pathogenic Listeria species has been found in your environment for a number of years. In 2017, Listeria innocua (L. innocua), a non-pathogenic Listeria species, was confirmed in (b)(4) swabs. Further, in 2018 L. innocua was confirmed in (b)(4)environmental swabs and Listeria welshimeri (L. welshimeri), a non-pathogenic Listeria species, was confirmed in (b)(4) environmental swabs. And in 2011, L. innocua was confirmed in (b)(4) environmental swabs. The presence of Listeriaspecies such as L. innocua and L. welshimeri suggests that conditions also are suitable for survival and/or growth of L. monocytogenes, which, as noted above, has been found in your facility.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Shannon J. Hall, Compliance Officer, Human Foods Program, Office of Compliance and Enforcement, Office of Compliance Intervention and Consultation – Division of Recalls and Emerging Issues, 5001 Campus Drive, College Park, MD 20740 or via email (preferred) at shannon.hall@fda.hhs.gov. If you have any questions, you may contact Compliance Officer Hall at shannon.hall@fda.hhs.gov. Please reference CMS #709592 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Priya Rathnam
Acting Office Director
Office of Compliance Intervention and Consultation
Office of Compliance and Enforcement
Human Foods Program

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/fresh-ready-given-fda-warning-letter-after-10-hospitalized-with-1-death-due-to-listeria/