FDA Enters Consent Decrees with Cheese and Fish Companies Over Listeria Contamination

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.

12 April 2012 --- 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 report problems with FDA-regulated products to their district office consumer complaint coordinator.

The news comes as a California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to be contaminated with Listeria monocytogenes (L. mono) bacteria.
 
According to a complaint for permanent injunction filed by the Department of Justice on behalf of the FDA, Yamaya USA, Inc., of Torrance, Calif., and its president, Daigo Irifune, prepared and processed fish and fish products under conditions that contributed to widespread L. mono contamination in their facility
 
The complaint alleges that Yamaya also failed to comply with FDA’s current good manufacturing practice (CGMP) and seafood hazard analysis critical control point (HACCP) regulations.

Under the terms of the consent decree, Yamaya must meet several FDA food safety requirements before it can resume manufacturing and distributing fish and fish products. The consent decree also requires that the firm destroy all foods that are currently in process or ready for shipment, and it must clean and sanitize the facility until laboratory results confirm no further L. mono contamination.
 
The firm must also hire a sanitation and food safety expert to develop and implement a Listeria monitoring program and a HACCP plan, and it must hire an outside auditor to conduct inspections of the facility at least once every three months for three years and once every year for two years after that, for a total of five years of auditing inspections.
 
The consent decree was signed by Judge John F. Walter of the U.S. District Court for the Central District of California on April 5, 2012.
 
No illnesses have been reported to date implicating Yamaya’s products.