FDA WARNING_LETTER - Jensen Farms - September 10, 2011

On October 18, 2011, the FDA issued a Warning Letter to Jensen Farms following a September 10, 2011 inspection of their produce packing facility in Granada, Colorado. This inspection was prompted by epidemiological and traceback investigations linking cantaloupe from Jensen Farms to a nationwide listeriosis outbreak, which, as of October 11, 2011, had sickened 116 people in 25 states and resulted in 23 deaths.

FDA laboratory analyses of cantaloupe samples from the facility found five out of ten positive for *Listeria monocytogenes*, with four matching outbreak strain cluster #2 and one matching cluster #4. This renders the cantaloupes adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)].

Furthermore, environmental swabs revealed widespread contamination: 13 of 39 swabs were positive for outbreak strains of *Listeria monocytogenes* (11 matching cluster #2, one matching cluster #4, and one matching cluster #3), and one swab was positive for a non-outbreak strain. These positive swabs were from food contact or adjacent surfaces, indicating poor sanitary practices. Consequently, the cantaloupe packed at the facility is also adulterated under Section 402(a