A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permanent injunction with the U.S. Food and Drug Administration.
Del Bueno, of Grandview, Wash., which processes a variety of cheeses and distributes them to specialty grocery stores and restaurants, and owner Jesus Rodriguez, agreed to terms of the consent decree entered by U.S. District Judge Lonny R. Suko of the Eastern District of Washington, on April 3.
Under the consent decree, Del Bueno cannot process or distribute food until it demonstrates that it has developed a control program to eliminate Listeria monocytogenes from its production facility and products. Listeria is a foodborne pathogen that can cause serious illness and death.
Del Bueno must, among other actions, hire an independent laboratory to collect and analyze samples for the presence of Listeria, retain an independent sanitation expert, develop a program to control Listeria for all employees in both English and Spanish, and destroy all food items currently in the facility. Once the company is permitted to resume operations, the FDA may still require the company to recall products or cease production if future violations occur.
“When a company continues to produce food that presents a risk for consumers, the FDA will take action,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “We will not hesitate to protect the public’s health.”
FDA and Washington State Department of Agriculture (WSDA) inspections since 2009 have documented numerous deficiencies in Del Bueno’s processing facility. In addition, FDA laboratory testing since 2010 also found Listeria monocytogenes in Del Bueno’s finished cheese products and in the Del Bueno facility. Both the FDA and the WSDA repeatedly advised Del Bueno and its owner of the unsanitary conditions at the facility.
Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes can cause fatal infections in young children, frail or older people, and others with weakened immune systems. Although healthy individuals may experience only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection in pregnant women can cause miscarriage and stillbirth.
In 2010, Del Bueno cheese was linked to a case of listeriosis in Washington state. Although no illnesses have been reported in 2012 from Del Bueno products, individuals who have eaten these products and experience any of the symptoms of listeriosis listed above should contact their health care professional. Consumers can report2 problems with FDA-regulated products to their district office consumer complaint coordinator.
For more information:
- Warning letter3 to Del Bueno, April 1, 2011
- Del Bueno recalls cheese4, November 17, 2010
- Del Bueno recalls queso fresco casero5, September 16, 2010
- Del Bueno recalls queso fresco6, April 6, 2010
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: FDA
