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FDA has its hands full with 10 open investigations


new outbreak of infections from Listeria monocytogenes has been reported by the FDA, bringing the agency’s number of open investigations to 10.

The Food and Drug Administration reports that it has begun on-site inspection and sample testing, but it has not found a specific source for the Listeria. It has not initiated traceback efforts. The agency reports there are six confirmed patients in the outbreak, but has not revealed their ages or the states where they live.

In other outbreak news, the patient count in an outbreak caused by Salmonella Mississippi has increased to 102 from the 100 patients reported a week ago.  The agency has not made public where the patients live or their ages. The FDA has not identified a source of the pathogen but has initiated traceback efforts. The agency has not reported what food or foods are being traced.

Other outbreaks with active FDA investigations

  • For a Salmonella Senftenberg outbreak from a not yet identified food, the patient count is steady at 27. Traceback has begun but FDA has not reported what is being traced.
  • For a Salmonella Typhimurium outbreak from a not yet identified food, the patient count is steady at 78. Traceback, on-site inspection and sample analysis has been initiated, but the FDA has not reported what is being traced or tested or where the inspection is taking place.
  • For a Cyclospora outbreak the patient count remains steady 79. Traceback has begun but the FDA has not reported what is being traced.
  • For another Cyclospora outbreak the patient count has remained steady at 42. Traceback has begun but the FDA has not reported what is being traced. Similarily, sample testing has begun but the agency has not reported what is being tested. 
  • An investigation related to adverse effects associated with Daily Harvest brand frozen Leeks & Lentils Crumbles is ongoing. The company has received more than 470 complaints of illnesses and as of its most recent report on July 29 the FDA had received 329 complaints. Some of the patients have gone into liver failure and at least 25 have had to have their gallbladders removed. The FDA is working on traceback efforts and has begun on-site inspection and product testing. Some testing has revealed that tara flour is an ingredient unique to the Daily Harvest crumbles product and could be related to the illnesses.
  • In an ongoing outbreak of infections caused by E. coli O157:H7 the FDA has initiated sample collection and analysis. The outbreak, reported by the CDC as being linked to lettuce on Wendy’s sandwiches, has sickened at least 84 people. The four-state outbreak has sickened more people according to the state counts, but all of the reports have not reached the CDC. Wendy’s has stopped serving the romaine-iceberg lettuce hybrid on sandwiches in several states, according to a statement from the company.
  • The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
  • An outbreak of infections from Cronobacter in four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.


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