"We have an obligation to make sure that foods are safe for people to consume. The FDA moved quickly after an L. mono outbreak to get the company to recall and destroy all its cheese products and cease production to prevent any more tainted food from harming consumers," says FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. "FDA investigators also found unsanitary conditions at Vulto Creamery's facility and this consent decree prevents the company and its owner from resuming operations until they can demonstrate to the FDA that their products are safe."

Vulto Creamery's ready-to-eat cheeses are considered adulterated because they contain L. mono—a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis. In addition, the products were prepared, packed and/or held under unsanitary conditions and the food may have become contaminated with filth or otherwise be harmful to health.

Before the company can resume operations, the consent decree requires it, among other things, to retain an independent laboratory to collect and analyze environmental and finished samples for the presence of L. mono, retain an independent expert and develop a program to control L. mono, and eliminate unsanitary conditions at its facility.

Earlier this year, the FDA, in collaboration with the Centers for Disease Control and Prevention, state and local officials, investigated a multi-state outbreak of listeriosis that was eventually linked to soft cheese produced by Vulto Creamery. Eight people were infected from four states, and two people died.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.

For more information: FDA form 483 inspection report, www.fda.gov