Jeni's Splendid Ice Creams is still fighting problems with listeria, a potentially deadly bacteria, according to regulators.
In a warning letter to the company's chief executive, dated Aug. 9, the U.S. Food and Drug Administration said it found a dangerous form of listeria in the company's Columbus, Ohio, manufacturing plant that supplies the base for Jeni's ice creams and frozen yogurts.
Regulators also found "significant" violations of good manufacturing practices spelled out in federal regulations during inspections earlier this year.
"Listeria is so widespread in the natural world, it will inevitably find its way into otherwise clean environments," said Mary Kamm, Jeni's quality leader. Ms. Kamm said the ice-cream maker tests every batch of frozen product it produces in the Ohio facility and doesn't distribute it until tests confirm that no listeria is present. Thanks to the company's sanitation, pathogen testing and other food-safety procedures, she said, "we can assure everyone that the food we produce is absolutely 100% safe."
The Columbus, Ohio, company operates ice-cream shops in seven states from Missouri to California and sells ice cream at Whole Foods Market Inc. and other retailers throughout the country.
The letter comes more than a year after the ice-cream maker pulled its frozen dessert products from grocery stores because of possible listeria contamination.
According to the FDA, two samples taken by inspectors in Jeni's Ohio facility during a January inspection tested positive for pathogenic listeria. The samples came from the floor of the prep room where Jeni's Intelligentsia Black Cat Espresso ice-cream base was being made and from a floor near where utensils and containers were stored.
An inspection last year in the same plant turned up 20 positive samples, after which the company closed its retail stores and voluntarily pulled its frozen-dessert products from supermarkets.
The ice-cream sector has struggled with food safety in recent years. Blue Bell Creameries LP recalled all of its frozen desserts from supermarket shelves last year after the U.S. Centers for Disease Control and Prevention linked its ice cream to three deaths and multiple other illnesses. The company since has resumed sales.
The U.S. Justice Department launched an investigation of Blue Bell's listeria outbreak. The status of the probe is unclear, and Blue Bell previously has declined to comment. It didn't immediately respond to a request for comment Wednesday.
According to the FDA's August warning letter to Jeni's, the listeria strain found earlier this year matches the one discovered in the plant and the company's ice cream last year, indicating the potentially deadly pathogen has been present in the facility since 2015.
The? FDA said its findings indicate Jeni's sanitation procedures historically have been insufficient "to control, reduce, or eliminate" listeria from its facility.
The agency's warning letter pointed to other violations that could lead to food contamination. For example, the FDA said that while bases for Buttermilk Yogurt, Brambleberry Crisp and Intelligentsia Black Cat Espresso were being made, a dust-like substance was present on the fan of a cooling unit mounted in a room where containers and utensils are washed and stored.
Jeni's responded to the FDA's concerns in March and April, telling regulators that it had taken steps, such as updating its cleaning procedure, and made plans to sample air units for bacteria. The FDA said it would determine whether these actions were sufficient during its next inspection.
The boutique frozen-dessert company must take "prompt action" to address all violations. The FDA said that if the company fails to do so, it could result in further enforcement actions, such as seizure or injunction.
According to the FDA, Jeni's took "extensive corrective actions" after its run-in with regulators in 2015, including temporarily ceasing production to perform a deep clean and sanitize the plant and hiring a sanitation consultant. The company also has made production changes since then, making only base flavors in its Ohio plant and shipping them to co-manufacturers for use in ice cream, frozen yogurt and sorbet, the FDA said.
Listeria is a pernicious pathogen that thrives in cool, wet environments. It doesn't typically cause serious illnesses in healthy people but poses a threat to pregnant women, newborns, older adults and people with weakened immune systems.
Write to Jesse Newman at firstname.lastname@example.org