November 29, 2021

Jule’s Foods FDA Warning Letter Details Salmonella Contamination

A Jule’s Foods FDA warning letter details the Salmonella contamination found at that company’s facility, after inspections were launched in relation to a multistate outbreak that sickened at least 20 people in four states and hospitalized five. The outbreak was declared over in early July 2021.

Jule's Foods FDA Warning Letter Details Salmonella Contamination

The facility is located at 2790 Loker Avenue West in Carlsbad, California. The FDA inspected the facility from April 21 to May 24, 2021. The outbreak included six Salmonella serotypes. Four of those serotypes were found in an environmental swab taken from the company’s vegan cashew brie, the vegan cashew brie varieties, and/or the incoming cashew pieces used to make these products. The CDC and FDA determined, based on epidemiologic and laboratory evidence, that the RTE vegan cashew brie products produced at that facility are the likely source of the Salmonella outbreak.

The four strains include Salmonella Leiden, which was found on the top of a table that holds a mixer in one of the facility kitchens. The company stated that they do not regularly clean that table and do not know the cleaning frequency by others who share that kitchen.

Salmonella Urbana was found in two intact samples of incoming raw organic cashew pieces. The California Department of Public Health found Salmonella Urbana in four samples of the ready to eat Jule’s Brie and Jule’s Truffle Brie. And the Tennessee Department of Health found Salmonella Urbana in one sample of Jule’s Truffle Brie.

Salmonella Chester was isolated from one sample of Jule’s Brie by California officials. Whole genome sequencing found that four clinical isolates were genetically identical to the strain of Salmonella Chester found in that sample, but there was no food history or traceback information available for those isoaltes.

Finally, Salmonella Vinohrady was isolated from one sample of Jule’s Black Garlic Brie that was aging at the facility. It was also found in Jule’s Brie collected from a retail location by California officials, and found in sample of Jule’s Truffle Brie collected at a retail location by Tennessee officials.

Raw materials must either not contain levels of pathogens that may render the food injurious to human health, or they must be pasteurized or treated during manufacturing so they are no longer contaminated with enough bacteria that would cause the product to be adulterated. The company did not treat the cashews so they no longer contained Salmonella, according to the warning letter.

The company responded to FDA requests with a cashew supplier Certificate of Analysis which is allegedly for a different lot of cashew pieces than the subject lot from which the FDA isolated Salmonella Urbana. The supplier was allegedly not controlling the hazard of Salmonella in raw cashews, so Jule’s Foods should not have relied on their testing to address the Salmonella hazard.

The company was asked to respond about specific steps taken address violations in the Jule’s Foods FDA warning letter. Supporting information and documentation were also requested.

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