In a warning letter dated Nov. 17, the Food and Drug Administration outlined problems at Bedner Growers Inc. of Boynton Beach, Florida, which sold cucumbers linked to salmonella outbreaks in 2024 and 2025. The agency determined that the manufacturer violated federal law.
The FDA inspected the company's farm from April 1 to April 3, 2025, in response to a multi-state outbreak of salmonella in humans in 2024. Africana and Salmonella Braenderup, during which the FDA also inspected your farm from June 5 to June 7, 2024.
As described below, based on investigations into Salmonella outbreaks associated with cucumbers from your farm in several states in 2024 and 2025, as well as positive environmental and product samples containing multiple strains of Salmonella, the cucumbers you grow and package are adulterated because they were prepared, packaged or stored in unsanitary conditions, which may have resulted in them being contaminated with Salmonella, human pathogen. Additionally, based on the analytical results of the cucumbers collected by the FDA on May 15, 2025, the FDA has determined that your cucumbers are adulterated because multiple strains of Salmonella were found in your cucumbers and those cucumbers were shipped into interstate commerce.
Following an inspection of your farm, FDA notified you of the sample results on April 16, 21, and 29, 2025. We received your written responses on May 16, 2025 and June 25, 2025 describing your corrective actions. We will review your written responses below.
2025 inspection
On April 2, 2025, the FDA collected a sample consisting of (edited) ecological brush strokes from your cucumber packaging line. The FDA analyzed the sample and determined that (edited) belonging (edited) swabs representing food contact surfaces were positive for Salmonella. Whole genome sequencing (WGS) analysis showed that as of May 7, 2025. (edited) isolates are the same (edited) 2025 clinical isolates in the National Center for Biotechnology Information database. Same (edited) isolates from the sample were pathogens associated with disease during the investigation of a multi-state Salmonella Montevideo human outbreak in 2025.
Multistate outbreak in 2025
The FDA and the Centers for Disease Control and Prevention, in collaboration with state and local partners, have been investigating illnesses caused by the Salmonella Montevideo outbreak in several states. A CDC epidemiological investigation concluded that cucumbers were the source of the outbreak. An FDA investigation found that cucumbers grown on your farm were the source of disease outbreaks. As of May 30, 2025, 45 people from eighteen states have been infected by the outbreak strain, and sixteen people have been hospitalized.
As part of the FDA's investigation, on May 15, 2025, the FDA collected samples of cucumbers determined to have been grown on your farm from a distribution center in Pennsylvania. Salmonella was detected and WGS analysis showed that two isolates from this sample matched the Montevideo strain of Salmonella causing the outbreak.
In addition, numerous other strains of Salmonella were found that matched other isolates in the National Center for Biotechnology Information database, including isolates from a multi-state outbreak of Salmonella Africana and Salmonella Braenderup in humans in 2024, and an isolate from a 2024 cucumber sample collected by the Pennsylvania Department of Agriculture that was also found to have originated on your farm.
FDA Evaluation of Your Written Responses
On May 16, 2025, FDA received your written response describing the corrective actions taken by your farm since April 14, 2025. We note that your written response did not provide supporting details or evidence of implementation other than a May 12, 2025 letter from the University of Florida describing a third party sampling attempt that occurred on your farm on April 16, 2025.
Let us note the following:
You stated that you took environmental samples, including soil samples, leaf tissue samples, equipment samples, product samples, and water samples. Collection method, laboratory analysis method and results were not provided. You have not provided information about when these samples were collected, what your rationale for collecting them was, what steps you would take based on the results of the analysis, and whether sampling will continue through the 2026 growing and harvest season as part of your farm's efforts to “(edited)” We cannot determine the adequacy of these corrective actions.
You provided a letter dated May 12, 2025 from the University of Florida describing a third party sampling attempt conducted at your farm on April 16, 2025. We understand that these swabs were collected after the cucumber production line was cleaned and disinfected. You did not provide information about how the cucumber production line was cleaned and sanitized, or whether the sanitation protocol used was representative of routine cleaning or representative of what will happen during the next growing and harvesting season. You did not provide information about whether the cucumbers were processed on the cucumber production line before it was cleaned or whether the number of cucumbers was representative of a normal production run.
You also stated that (edited) on your cucumber line, (edited). No additional supporting documents were provided. Our results of detecting Salmonella on the food contact surfaces of your cucumber packaging line, as well as on cucumbers grown on your farm, after you took corrective actions, indicate that your corrective actions were inadequate.
You stated that (edited). We will review these fixes during a follow-up audit of your farm.
You stated that you (edited). You have not provided a rationale for this change, how you implemented it, and how you trained your employees based on this change. We will review these fixes during a follow-up audit of your farm.
You referred to “(edited)” And “(edited)” in your written response. These documents were not received, so we cannot further evaluate these documents or subsequent implementation. We will review these actions during a subsequent inspection of your farm.
Additionally, on June 25, 2025, FDA received a letter from you informing you that your 2025 season had ended, that you would not be renewing your land lease for 2026, and that you would not be growing produce for wholesale sale. You have not provided information about whether you will continue to grow on land that is not leased (other properties), whether your land lease could potentially be extended beyond 2026, whether you will continue to grow for retail, or what your plans are for your cucumber packaging line where we discovered an outbreak of the Montevideo strain of Salmonella in 2025. FDA cannot estimate the scope or impact of your future activities based on the limited information provided in your letter. Regardless of your stated intentions, you must ensure that any ongoing business operations comply with all applicable requirements of the Product Safety Regulations and the Law.
The full version of the warning letter is available Here.
