The FDA has released Form 483 as part of its investigation into the Raw Farm raw cheese E. coli O157:H7 outbreak. The form confirms that Raw Farm raw cheese was the source of that outbreak. Lab tests did find a different strain of Shiga Toxin producing E. coli (STEC) in shredded raw milk Cheddar cheese produced by that farm, but that strain is linked to a 2025 outbreak.
The case count by state is: California (7), Florida (1), and Texas (1). The patient age range is from 1 to 28 years, with the median age of 2. More than half of the patients are under the age of five. Illness onset dates range from September 1, 2025 to February 20, 2026. Of the eight patients who gave information to public health officials in interviews, three have been hospitalized, for a hospitalization rate of 37.5%. One person has developed hemolytic uremic syndrome (HUS), a type of kidney failure. Of the seven people who had information about what they ate before they got sick, all seven reported consuming Raw Farm dairy products.
The form states that, based on the combined epidemiologic, limited traceback, and laboratory data, raw cheddar cheese and raw milk from RAW FARM, LLC were confirmed as the outbreak vehicles. Epidemiologic analysis and a limited traceback investigation identified that farm as the common supplier for raw cheddar cheese products that were consumed by or served to the cases in this outbreak.
Full scope, for cause inspections with sample and data collection were performed at three of the farm’s locations. Inspectors found inadequate maintenance of equipment, lack of retentive controls, and unsanitary handling of product during processing and production.
