Warning Letter to Bedner – Let’s stop producing Salmonella Cucumbers

WARNING LETTER

November 17, 2025

Re: 706726

Dear Mr. Bedner,

The U.S. Food and Drug Administration (FDA or we) conducted an inspection of your farm located at 10066 Lee Road, Boynton Beach, FL, from April 1, 2025, through April 3, 2025, in response to the 2024 multi-state outbreak of human infections with Salmonella Africanaand Salmonella Braenderup during which FDA also conducted an inspection of your farm from June 5, 2024, through June 7, 2024.

As described below, based on the 2024 and 2025 multi-state outbreak investigations of Salmonella linked to cucumbers from your farm, and positive environmental and product samples containing multiple strains of Salmonella, the cucumbers you grow and pack 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 Salmonella, a human pathogen. Further, based on analytical results of cucumbers collected by FDA on May 15, 2025, FDA determined that your cucumbers are adulterated within the meaning of section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that your cucumbers yielded multiple strains of Salmonella, and these cucumbers were shipped in interstate commerce. It is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. 331(a). You can find the Act and FDA regulations and the applicable regulations through links on FDA’s home page at www.fda.gov.

After the inspection of your farm, FDA notified you of sample results on April 16, April 21, and April 29, 2025. We received your written responses on May 16, 2025, and June 25, 2025, describing your corrective actions. We address your written responses below.

2025 FDA inspection at Bedner Growers, Inc.
On April 2, 2025, FDA collected Sample 1148702 consisting of (b)(4) environmental swabs from your cucumber packing line. FDA analyzed Sample 1148702 and determined that (b)(4) of the (b)(4) swabs, representing food contact surfaces, were positive for Salmonella. Whole Genome Sequencing (WGS) analysis revealed that, as of May 7, 2025, (b)(4) isolates matched (b)(4) 2025 clinical isolates in the National Center for Biotechnology Information’s (NCBI) database that were uploaded April 25, 2025, or later. The same (b)(4) isolates from sample 1148702 were pathogens associated with illness in the 2025 multi-state outbreak investigation of human infections with SalmonellaMontevideo described below.

2025 multi-state outbreak of human infections with Salmonella Montevideo
FDA and the Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, investigated illnesses in a multistate outbreak of SalmonellaMontevideo infections. CDC’s epidemiologic investigation concluded that cucumbers were the outbreak vehicle. FDA’s traceback investigation determined cucumbers grown at your farm were the source the outbreak illnesses. As of May 30, 2025, forty-five people from eighteen states were infected with the outbreak strain, and sixteen people have been hospitalized.

As part of FDA’s investigation, on May 15, 2025, FDA collected Sample 1298712, cucumbers determined to have been grown at your farm, from a distribution center in Pennsylvania. Salmonella was detected and WGS analysis determined that two isolates from this sample matched the Salmonella Montevideo outbreak strain. In addition, multiple other strains of Salmonella were detected which matched other isolates in the National Center for Biotechnology Information’s (NCBI) database, including isolates from the 2024 multistate outbreak of human infections with Salmonella Africana and SalmonellaBraenderup, and an isolate from a 2024 cucumber sample collected by the Pennsylvania Department of Agriculture, which was also determined to have been grown at your farm.

FDA’s Evaluation of Your Written Responses
On May 16, 2025, FDA received your written response, describing corrective actions taken by your farm since April 14, 2025. We note that your written response lacked supporting details, or evidence of implementation, except for a letter from the University of Florida, dated May 12, 2025, which describes the 3rd party sampling effort that occurred at your farm on April 16, 2025. As such, we note the following:

• You stated that you have conducted environmental samples which include soil samples, leaf tissue samples, equipment samples, product samples, and water samples. The collection method, lab analysis method, and results were not provided. You did not provide information regarding when these samples were collected, what your rationale was for collecting them, what steps you would have taken depending on the analysis outcome, and if sampling will continue during the 2026 growing and harvesting season as part of your farm’s effort to “(b)(4).” We are unable to determine the adequacy of these corrective actions.
• You provided a letter from the University of Florida, dated May 12, 2025, which describes the 3rd party sampling effort that occurred at your farm on April 16, 2025. We recognize that these swabs were collected after the [cucumber] line had been cleaned and sanitized. You did not provide information regarding how the [cucumber] line was cleaned and sanitized, or if the sanitation protocol used was representative of a routine cleaning, or representative of what will occur during the next growing and harvesting season. You did not provide information regarding whether cucumbers were processed on the [cucumber] line prior to cleaning it, and if the quantity of cucumbers were representative of a normal production run.
• You also stated that, (b)(4) on your cucumber line, (b)(4). No additional supportive documentation was provided. Our findings of Salmonella on food contact surfaces of your cucumber packing line, as well as on cucumbers grown at your farm, after your corrective actions were taken, demonstrate that your corrective actions were not adequate.
• You stated that (b)(4). We will verify these corrections during a follow-up inspection of your farm.
• You stated that you (b)(4). You did not provide your rationale for this change, how you have implemented this change, and how you have trained your employees based on this change. We will verify these corrections during a follow-up inspection of your farm.
• You referenced a “(b)(4)” and “(b)(4)” in your written response. These documents were not received so we cannot further evaluate these documents or the subsequent implementation. We will verify these actions during a follow-up inspection of your farm.

In addition, on June 25, 2025, FDA received a letter from you titled, “(b)(4)”, noting that your 2025 season has ended, that you will not be renewing your land leases for 2026, and that you will not be growing produce for wholesale distribution. You did not provide information regarding whether you will continue to grow on land that is not leased (other properties), whether your land leases could potentially be renewed after 2026, whether you will continue to grow for retail distribution, or what your plans are for your cucumber packing line, where we detected the 2025 outbreak strain of Salmonella Montevideo. FDA cannot assess the scope or impact of your future operations based on the limited information provided in your letter. Regardless of your stated intentions, you must ensure that any continuing business operations comply with all applicable requirements of the Produce Safety Rule and the Act.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your farm 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 your farm 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 if criteria and conditions warrant.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter, of the specific steps and corrections 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will do so.

Please send your reply to the U.S. Food and Drug Administration, Attention: Joel Merriman, Compliance Officer, via email at Joel.Merriman@fda.hhs.gov. If you have any questions about the content of this letter, please contact Joel Merriman at 301-796-5255.

Sincerely,
/S/

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

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/warning-letter-to-bedner-lets-stop-producing-salmonella-cucumbers/