FDA NEWS RELEASE
For Immediate Release: Oct. 8, 2009
Update: On November 3, 2009, Judge Maria-Elena James in the Northern District of California entered a consent decree of permanent injunction in this case. The defendants are now prohibited from processing and distributing food until they demonstrate to the FDA that their facility and processing equipment are suitable to prevent contamination in the food that they process, prepare, store, and handle. The defendants must, among other provisions in the consent decree, retain an independent laboratory to collect and analyze samples for the presence of Listeria monocytogenes (L. mono.), retain an independent sanitation expert, and develop a program to control L. mono. at their facility that is accessible to all employees in both English and Spanish. Under the consent decree, once operations resume, the FDA may require the company to stop production and conduct a recall of distributed products if the Agency discovers future violations.
Media Inquiries: Stephanie Kwisnek, 301-796-4737, Stephanie.Kwisnek@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA
FDA Takes Enforcement Action against Ready-to-Eat Sandwich Manufacturer
Company allegedly failed to correct violations
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop the company from manufacturing, producing, and selling adulterated food products.
The complaint also names Rel's Vice President, Peder Scott Sorensen, and two managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares, processes, and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts, and gas stations in Nevada and California.
The government's complaint, filed this week in the U.S. District Court, Northern District of California, alleges that Rel's has an extensive history of operating under insanitary conditions. The complaint states that Rel's has produced and distributed ready-to-eat sandwiches contaminated with Listeria monocytogenes (L. mono). Listeriosis, the illness caused by L. mono, can cause fatal infections in young children, the elderly, and individuals with weakened immune systems, and pregnant women may suffer miscarriages or stillbirths as a result of the infection.
The complaint alleges that FDA investigators have found L. mono inside Rel's production facility on numerous occasions since 2002. Additionally, routine laboratory testing by the Department of Defense and the California Department of Public Health, Food and Drug Branch (CFDB) found L. mono in the company's processing plant and finished sandwiches. Based on recent laboratory analyses, CFDB has embargoed and seized all in-process and finished products inside the facility.
The FDA and CFDB inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found poor employee sanitation practices and inappropriately maintained facility and manufacturing equipment, including excessive condensation dripping onto food contact surfaces.
“Rel's lack of effective measures to bring its food processing operations into compliance with the law poses a serious public health threat,” said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. “The company's failure to comply with good manufacturing practice also demonstrates the potential for the company to continue to manufacture contaminated products.”
No illnesses have been reported so far from Rel's products. Individuals who have eaten the products and who experience symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.