FDA Launches Onsite Inspections in Two Active Outbreak Probes
FDA inspectors are on site at undisclosed locations in a 13-case raw milk cheese E. coli outbreak and an 11-case Listeria outbreak with no known source.
The FDA has begun onsite inspections in two separate outbreak investigations: an E. coli O26:H11 outbreak tied to unpasteurized grass-fed raw milk cheeses that has sickened at least 13 people across nine states, and a Listeria monocytogenes outbreak of unknown origin with 11 patients.
The cheese outbreak involves Sierra Nevada Nevada Graziers grass-fed raw milk cheeses distributed nationwide. The FDA has not disclosed which facility or location inspectors are visiting.
Eight of the 13 patients required hospitalization. Three developed hemolytic uremic syndrome, a complication that causes kidney failure and can lead to brain damage or death. Confirmed cases span California, Colorado, Georgia, Kentucky, Michigan, Nevada, Oregon, Tennessee and Utah.
What do we know about the Listeria outbreak?
The second investigation involves Listeria monocytogenes infections with no identified food source. The FDA reports 11 patients but has not released their ages or locations. The agency previously initiated traceback efforts but has not said what food it is tracing. Onsite inspections are underway at an undisclosed location.
What caused the 38-case E. coli O157:H7 outbreak?
In a separate investigation, the FDA has confirmed the source of 38 E. coli O157:H7 infections: ready-to-eat, multi-ingredient chicken wraps. Neither the FDA nor the USDA — which holds jurisdiction because the product contains chicken — has disclosed the brand or where the wraps were sold.
The FDA has opened an onsite inspection at an undisclosed location. The implicated wraps were pulled from the market before the outbreak link was confirmed and are now past their shelf life, according to the agency. The USDA has posted no independent information on the outbreak, linking only to the FDA's outbreak table. The FDA continues to investigate whether contamination occurred at the ingredient level.
Has the Salmonella outbreak been resolved?
An outbreak of Salmonella I 4,[5],12:i:- has ended, though the FDA's investigation remains active. The outbreak sickened 43 people; the agency has not revealed patient ages or locations. Inspectors are conducting onsite inspections, traceback and sample testing, but the FDA has not reported where the inspections are occurring, what food is under traceback, or what is being tested.
For foodservice operators, the cheese outbreak carries direct menu implications: any operator sourcing Sierra Nevada Graziers raw milk cheeses should verify inventory and supplier documentation, as the products were distributed nationwide. The ongoing ingredient-level probe into the chicken wraps signals that suppliers to the ready-to-eat category could still face scrutiny as the FDA works to pinpoint where contamination entered the supply chain.
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