Last week, Blue Bell Creameries agreed to plead guilty to charges that the company shipped contaminated products linked to a 2015 Listeria outbreak. Also, the company’s former president was charged in connection with a scheme to cover up the incident.
A U.S. Department of Justice press release describes the Texas-based ice cream manufacturer’s guilty plea to two misdemeanor counts of distributing adulterated ice cream products. Blue Bell must pay a criminal fine and forfeiture amount totaling $17.25 million. The company also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding the ice cream products manufactured under unsanitary conditions and sold to federal facilities. The total $19.35 million is the second largest amount ever paid in the resolution of a food safety matter.
Blue Bell is accused of distributing ice cream products that were manufactured under unsanitary conditions and contaminated with Listeria monocytogenes, a violation of the Food, Drug, and Cosmetic Act.
In February 2015 when Texas state officials notified Blue Bell that two of its ice cream products made in their Brenham, TX, facility had tested positive for the presence of Listeria, the company directed its delivery route drivers to remove all remaining stock of the two implicated products from store shelves instead of issuing a recall or formally notifying customers about the potential health hazard.
Two weeks after initially hearing from Texas officials about positive Listeria samples, Blue Bell was notified once again about a third product that contained Listeria. Again, Blue Bell chose not to issue any recall or notification to customers.
In March 2015, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) conducted tests, finding that the Listeria strain found in one of Blue Bell’s products was the same strain that sickened five patients in a Kansas hospital. This prompted FDA, CDC, and Blue Bell to issue product recalls. Further testing also detected Listeria in yet another product made at an Oklahoma Blue Bell plant, prompting a second recall to be issued that same month.
Records show that FDA inspections in March and April 2015 revealed sanitation issues at the Texas and Oklahoma facilities where Blue Bell’s contaminated products were manufactured. Inspection records documented problems with the hot water supply and deteriorating factory conditions that could lead to unsanitary circumstances.
Blue Bell temporarily closed all of its plants in April 2015 for cleaning and other updates. Since then, the company has enhanced its sanitation methods and started a program to conduct Listeria testing prior to shipment.
Blue Bell’s former president, Paul Kruse, was simultaneously charged with seven felony counts related to allegedly concealing from customers what the company knew about Listeria contamination in its products. Besides directing Blue Bell employees to remove potentially contaminated products from store freezers without issuing a formal recall, Kruse also allegedly told employees to cite unspecified manufacturing issues if customers inquired about missing product in stores.
The civil False Claims Act settlement with the company resolves allegations that Blue Bell shipped ice cream products manufactured in unsanitary conditions to U.S. facilities and later failed to abide by contractually required recall procedures when its employees removed products from federal purchasers’ freezers without properly disclosing details about the potentially contaminated ice cream to the appropriate federal officials.
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FDA Report Shows Blue Bell Food Safety Violations Dating Back 8 Years
