FDA WARNING_LETTER - Jule's Foods - May 24, 2021

The FDA inspected a ready-to-eat (RTE) vegan cashew brie products manufacturing facility from April 21 to May 24, 2021, as part of a multi-state *Salmonella* outbreak investigation. The Centers for Disease Control and Prevention (CDC) reported 20 people from 4 states infected with *Salmonella* serotypes (Duisburg, Urbana, Leiden, Vinohrady, Chester, and Typhimurium).

FDA found four of these *Salmonella* serotypes (Urbana, Leiden, Vinohrady, and Chester) in environmental swabs, vegan cashew brie varieties, and/or incoming cashew pieces at the facility. Epidemiologic and laboratory evidence indicates the RTE vegan cashew brie products are the likely source of the outbreak.

The products are deemed adulterated under sections 402(a)(4) and 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions and bearing a poisonous substance. Introducing adulterated food into interstate commerce violates section 301(a) of the Act.

Specific *Salmonella* strains isolated include: * *Salmonella* Leiden: Found on a table holding a mixer in Kitchen (b)(4), used after fermentation. The facility admitted to not regularly cleaning this table. * *Salmonella* Urbana: Isolated from incoming raw organic cashew pieces and RTE