WARNING LETTER

Barcelona Nut Company Inc. MARCS-CMS 721619 — March 03, 2026

Delivery Method:: VIA ELECTRONIC DELIVERY
Product:: Food & Beverages

Recipient:: Recipient Name

Anthony Tsonis; Recipient Title

Owner; Barcelona Nut Company Inc.; 500 S. Fulton Avenue
Baltimore, MD 21223-3423
United States; tonyt@barcelonanut.com

Issuing Office:: Human Foods Program; United States

March 3, 2026

WARNING LETTER

Re: CMS 721619

Dear Mr. Tsonis:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) foods manufacturing and repacking facility for nuts, seeds, candies and trail mixes, located at 500 S Fulton Avenue, Baltimore, MD, from May 29 through June 26, 2025. During our inspection, 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).

Based on FDA's inspectional findings, we have determined that the RTE nut and seed 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 may have been 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 a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. An amended FDA-483 was issued on July 2, 2025, to address corrections on the form. We received your written responses on July 3 and July 9, 2025, describing your planned and implemented corrective actions, including updates to your hazard analysis. Based on our review of the inspectional findings and your responses, we are issuing this letter to advise you of our concerns and provide detailed information describing the findings at your facility. We address your response below.

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

Your significant violations are as follows:

1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they required preventive controls, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis for oil roasting did not identify allergen cross-contact as a hazard requiring a preventive control. Your facility operates a (b)(4) oil roaster, which is used to roast products with different allergen profiles, including cashews, peanuts, almonds, and sunflower kernels in the same oil. At the end of the production day after oil roasting has concluded, (b)(4). You replace the oil after approximately (b)(4) lbs. of product have been roasted.

Your July 3, 2025, written response shows your revised hazard analysis now includes allergen cross-contact as a hazard with the control measure, “(b)(4)” and a revised roasting log with the instruction to “(b)(4).” However, filtration using a (b)(4) inch ((b)(4) μm) pore-size wire cloth would not sufficiently remove peanut or tree nut proteins that may be present in the roasting oil. Roasting even small quantities of peanuts or cashews in oil can result in significant protein transfer to the oil, and the amount of protein transferred increases with the number of batches processed. Given that your facility processes up to (b)(4) lbs. of product in the same oil before replacement, substantial amounts of allergen proteins could accumulate in the oil over multiple production runs. Therefore, your proposed corrective action would not significantly reduce the risk of allergen cross-contact. More effective control measures, such as oil replacement between different allergen products or the use of filtration treatments that have been demonstrated to remove allergen proteins¹ would be necessary to adequately address this hazard.

2. Your written process preventive control procedures were not appropriate to significantly minimize or prevent hazards requiring preventive controls, as required by 21 CFR 117.135(c)(1). Specifically, your CCP Monitoring and Frequency revised March 13, 2019, for the roasting of peanuts shows the critical limits “(b)(4)” with “(b)(4)”, which is not sufficient for the reduction of Salmonella on peanuts. Your July 3, 2025, written response shows that your revised CCP Monitoring and Frequency dated July 3, 2025, included roasting times of a minimum of (b)(4) minutes and a maximum of (b)(4) minutes, and temperatures of “(b)(4)” Fahrenheit; however, these parameters still do not ensure an adequate lethality treatment for the reduction of Salmonella. You did not provide any validation data for your roasting process or scientific justification demonstrating that your process parameters are adequate to ensure a safe product. See 21 CFR 117.160.

Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B)

3. You did not take effective measures to exclude pests from your facility to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, FDA Investigators observed a dead rodent, insects, and apparent rodent excreta pellets (REPs) too numerous to count (TNTC) on food-contact surfaces, equipment, and food production areas. These findings were:

On June 26, 2025, a dead rodent and fly pupae were observed in a bucket on the floor by the oil roaster for cashews, peanuts, almonds, and sunflower kernels.
On June 26, 2025, approximately (b)(4) apparent REPs were observed in the food-contact bucket elevator of the roasting machine.
On May 29, 2025, the following conditions were observed:
o Apparent REPs TNTC were observed with loose sunflower seeds on the bottom two layers of plastic wrapping around bags on (b)(4) pallets of (b)(4)-pound bags of sunflower seeds, stored in the warehouse.
o (b)(4) apparent REPs were observed on plastic dividers where clean inverted food-contact buckets were placed on rolling carts in the roasting room.
o Approximately (b)(4) apparent REPs were observed on top of the roasting machine by the saltshaker motor in the roasting room.
o Apparent REPs TNTC were observed along the walls of the roasting room and inside catch bins on the floor under the roasting machine.

During the inspection, you stated that you voluntarily destroyed eight bags of CHS Processed Sunflower Seeds Lot#(b)(4) due to apparent REPs on the bags and within the shrink wrap; one roll of food-contact film for Barcelona MOJO Trail Mix where apparent REPs were observed at the interior of the paper tube; and one roll of food-contact film for Royal Farms Dark Chocolate Blueberry Acai with apparent REPs observed near the film. However, your written response did not address how you will mitigate the pest infestation issue throughout your facility that poses a serious contamination risk to your food products, equipment, and production areas.

4. You did not clean food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food as required by 21 CFR 117.35(d). Specifically, you package products with different allergen profiles on the same packaging machine and after cleaning was confirmed as completed on the Tron packaging line prior to changing from cashews to chocolate products on June 18, 2025, cashew residues remained in the hopper and on the flexible tube that delivers product to the packaging film. You did not submit a response to this observation.

5. Your plant was not constructed to facilitate maintenance and sanitary operations and permit taking of adequate precautions to reduce the potential for contamination as required by 21 CFR 117.20(b) and 21 CFR 117.20(b)(2). Specifically, you use overhead canopy shields as a cover for exposed sections of food processing equipment from the wooden ceiling of the approximately 150-year-old building. During the inspection, FDA investigators observed food containers being opened with in-process product outside the area protected by overhead canopy shields, prior to filling the hopper. Additionally, floors were not constructed in a manner that they are adequately cleanable and kept in good repair, as required by 21 CFR 117.20(b)(4). On the second floor, the wooden floors were observed to have holes and to be heavily splintered, preventing adequate cleaning and creating potential sources of contamination.

In response to this observation, your July 9, 2025, written response states that buckets, boxes, and rework packaging will only be opened at the hopper area under the canopy, and that the upstairs floor is being cleaned, sanded, and finished to a smooth surface. However, this response is inadequate. You did not address the fundamental structural and sanitation deficiencies identified in the approximately 150-year-old building, particularly the exposed wooden ceilings over food production areas. The proposed procedural changes do not resolve the underlying construction issues that prevent the facility from facilitating proper maintenance and sanitary operations.

6. You did not take reasonable measures and precautions related to personnel practices, as required by 21 CFR 117.10. Employees working in direct contact with food, food-contact surfaces, and food-packaging materials did not conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food. Specifically, the following employee practices were observed:

On June 18, 2025, an employee with a beard was observed not wearing a beard net while filling hoppers with in-shell peanuts.
On June 11, 2025, two employees were observed wearing necklace in the production area while your facility was packaging unsalted cashews.

You did not submit a response to this observation.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that 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 applicable 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 including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

We also have the following comments:

Your hazard analysis did not identify recontamination with environmental pathogens as a hazard requiring a preventive control. Your facility manufactures RTE nuts and seeds that are exposed to the environment during (b)(4) steps. Your Plant Manager stated that (b)(4), the RTE nuts and seeds are allowed to cool on a cooling conveyor exposed to the environment before being stored in containers. The RTE products are (b)(4) at the (b)(4) table in batch sizes between (b)(4) lbs. and (b)(4) lbs. The product is exposed to the (b)(4) table for approximately (b)(4) during the (b)(4) process. The packaged food does not receive any further lethal treatment.

Your July 3, 2025, written response regarding your proposed control measure of transferring product to buckets at (b)(4)°F and storing them in an air-conditioned warehouse does not address how you will prevent environmental pathogen contamination during the (b)(4) process when RTE products remain exposed. Furthermore, your firm collects a total of (b)(4) swabs annually to test for Listeria and Salmonella. If your products are RTE and recontamination with environmental pathogens is a hazard that requires a preventive control, FDA would expect your firm to have a sanitation preventive control program that includes a robust environmental monitoring program to verify the effectiveness of the sanitation preventive control.

Please notify FDA in writing within fifteen (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 fifteen (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: Tracy Li, Compliance Officer, via email at tracy.li@fda.hhs.gov. If you have any questions regarding this letter, you may contact Tracy Li, Compliance Officer, via email at tracy.li@fda.hhs.gov. Please include reference CMS 721619 in submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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1 For example, several published scientific studies have shown that use of filters with pore sizes of less than or equal to 25 μm was effective in minimizing levels of peanut or tree nut proteins in oils that are reused during nut roasting.