"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 Salmonella Montevideo described below.""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 Salmonella Braenderup, 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.""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."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bedner-growers-inc-706726-11172025
WARNING LETTER
Bedner Growers, Inc.
MARCS-CMS 706726 — November 17, 2025
WARNING LETTER
Bedner Growers, Inc.
MARCS-CMS 706726 — November 17, 2025