La Cabana Food Distributing, Inc.

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July 29, 2026

WARNING LETTER

Re: CMS # 724211

Dear Mr. Gonzalez:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) manufacturing facility, located at 649 Benet Rd, Oceanside, CA 92058 from November 12, 2025 through December 5, 2025. During the 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 regulations (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 the RTE cooked salsa and uncooked sauce products manufactured in your facility 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 FDA’s regulations through links on FDA’s homepage at www.fda.gov.

At the conclusion of the inspection, FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. On December 29, 2025, we received your firm’s response to the FDA-483 via email, describing corrective actions taken and planned by your firm. Based on our review of the inspectional findings and the response that you provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We discuss your response below.

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

1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they require preventive controls, as required by 21 CFR § 117.130(a)(1).

Specifically, your hazard analysis for refrigerated “Salsas (Cooked)” (e.g., Salsa Verde Cups) states “Biological: None Identified” at (b)(4) steps including “(b)(4)”. It does not specify that the hazard of contamination with environmental pathogens, such as L. monocytogenes, is a hazard requiring a preventive control at these steps. Environmental pathogens are a foreseeable hazard at each of the above-mentioned steps because RTE food is handled by employees while being exposed to the environment. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens (e.g., L. monocytogenes) at the aforementioned stages as a hazard requiring a preventive control (e.g., 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)).

We note that you established sanitation controls for other stages of the process, in addition to an environmental monitoring procedure to verify the effectiveness of your sanitation program. However, your environmental monitoring procedure titled “STANDARD OPERATING PROCEDURE, Environmental Monitoring, QA: 2.4.8 -01” did not identify:

• L. monocytogenes as a test microorganism
• the test(s) to be conducted, including the analytical method(s), for environmental pathogens or appropriate indicator organisms
• the laboratory conducting the testing

In addition, in practice, you did not test your environmental samples for L. monocytogenes or an appropriate indicator organism for this pathogen.

FDA collected environmental sample # 1284450 at your facility on November 18, 2025. FDA analysis revealed the presence of L. monocytogenes, an environmental pathogen. The positive swabs were recovered from non-food contact surface areas in your production environment, including the scale surface used to weigh buckets and tubs which hold ingredients, wheels and surfaces on carts, and the floor. 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.

Whole genome sequencing (WGS) analysis was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental swabs. Based on the results of the WGS analysis, as of December 23rd, 2025, the isolates represent a single unique strain of L. monocytogenes that does not match, or cluster with, any other isolates in the public NCBI Pathogen Detection database. We advised you of the importance of these WGS results via a conference call on January 8, 2026.

The presence of L. monocytogenes in your facility demonstrates that your sanitation efforts have been inadequate to significantly minimize or prevent L. monocytogenes in your facility. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementation of 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 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 grow (i.e., harborage sites), and to apply controls or take 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.

Your written response does not demonstrate that you have eradicated the L. monocytogenes in your production environment. Although your “001-CAPA” documentation notes that you have implemented certain corrective and preventive actions, such as “Clean-up documentation, visual inspection, scheduled swabbing for Listeria Monocytogenes,” and you attached a new “SSOP For Bins or Totes” and a “Listeria Control Program SQF Module 2 V.9”, it is unclear whether you have conducted any intensified cleaning and sanitizing of the affected surfaces that tested positive for L. monocytogenes or if you conducted resampling. Your written response states that a “Listeria Sampling Map” was included in the attachments, but we are unable to locate this attachment. You attached a document titled “Environmental Testing Areas” which appears to be a checklist for “Environment or Equipment to be swabbed” on a (b)(4) basis, but it is not filled. Therefore, it is unclear whether you have implemented the use of this document. Your written response also includes a revised Environmental Monitoring Program titled "Environmental Monitoring… SQF Module 11 V.9" which provides instruction on who should collect environmental samples (including for L. monocytogenes) and how they should be collected, but it still does not include the test(s) to be conducted.

Supply-Chain Program (21 CFR Part 117, Subpart G)
2. Your supply-chain program did not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required by 21 CFR § 117.410(c).

Specifically, your hazard analysis for refrigerated "Sauces (Uncooked)" appropriately identified a biological hazard (e.g., Salmonella) in ingredients at dry receipt as requiring a supply-chain-applied control. RTE produce ingredients (e.g., tomatoes and jalapeño peppers) have been associated with vegetative bacterial pathogens such as Salmonella. You do not apply a kill step to these produce ingredients for your uncooked salsa.

You receive RTE produce ingredients from a packinghouse. You informed our investigators that the packinghouse also de-stems the produce, but you weren’t sure if they conduct other activities such as a produce wash. Your hazard analysis specifies the control measures for biological pathogen contamination at dry receipt as: “Supply-chain; Supplier Preventive COA. Incoming materials inspection procedure. Rejection of loads deemed to be of risk.” Also, your “Approved Supplier Program, QA 2.3.4-01” requires that raw materials be inspected against (among other things) a Certificate of Analysis and checks for unsealed containers and other indications that food safety may have been adversely impacted. Reviewing supplier COAs and in-facility inspections are not appropriate controls for ensuring that biological pathogen contamination at dry receipt has been significantly minimized or prevented, for the produce you use as RTE ingredients. Given that neither you nor the packinghouse are seemingly implementing appropriate controls, the appropriate entities to implement a supply-chain-applied control for the biological pathogen contamination hazard for such ingredients in this case are the farms that grow the ingredients.

For example, your supply-chain program did not provide assurance that your identified hazard of biological pathogen contamination was significantly minimized or prevented for the following RTE produce ingredients:

a. You received tomatoes from a packinghouse and used them in the production of (b)(4), lot #(b)(4), on (b)(4). The tomatoes were grown on a farm in (b)(4).

b. You received jalapeño peppers from a packinghouse and used them in the production of (b)(4), lot #(b)(4), on (b)(4). The jalapeño peppers were grown on a different farm in (b)(4).

If a supply-chain-applied control is applied by an entity other than your supplier, you must (1) verify the supply-chain-applied control; or (2) obtain documentation of an appropriate verification activity from another entity, review and assess the entity's applicable documentation, and document that review and assessment (see 21 CFR § 117.405(c)). In this circumstance, for example, if a supply-chain-applied control is applied by the farm, you could conduct an onsite audit of the farm’s supply-chain-applied control (since vegetative bacterial pathogens in RTE produce such as tomatoes and jalapeño peppers are hazards that can cause serious adverse health consequences or death). Alternatively, another entity (e.g., the packinghouse) could conduct such an audit, and you could review and assess the applicable audit documentation and document your review and assessment.

Your written response attached documents titled “Approved Supplier Program SQF Module 2 V.9” and “Supplier Self-Assessment Form SQF Module 11 V.9”, which relate to approval, monitoring, and verification procedures for your suppliers. However, the provided documents do not provide assurance that the hazard of biological pathogen contamination requiring a supply-chain-applied control has been significantly minimized or prevented for RTE produce ingredients.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
3. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4). For example:

a. On November 20, 2025, multiple uncovered cases of peppers were stored under the (b)(4) fan in the (b)(4) room. FDA investigators observed condensate dripping from the unit onto the peppers.

b. On November 12, 2025, (b)(4) cases of de-stemmed Anaheim peppers were stacked on top of each other in the Freezer room. The peppers were stored under the (b)(4) fan where there were visible frozen condensate icicles originating from the (b)(4) unit. The upper case of peppers was uncovered, and FDA investigators observed visible frozen condensate on top of the exposed peppers.

Your written response included the documents titled “002-CAPA Condensate Icicles In Freezer” and “003-CAPA Condensate in Produce Room” which indicate you have corrected the issues related to the frozen condensate leaking from the (b)(4) in your freezer room and the leaking condensate from the (b)(4) fan in your (b)(4) room. FDA will verify the effectiveness of these corrective actions during the 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. Failure to adequately address this matter 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.

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 written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Daniel Johnson, Compliance Officer, at Daniel.Johnson@fda.hhs.gov. If you have any questions regarding any issues in this letter, please contact Daniel Johnson via email at: Daniel.Johnson@fda.hhs.gov. Please reference CMS #724211 on any submissions within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program