FDA Files Complaint Against Ready-to-Eat Sandwich Supplier

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FDA Files Complaint Against Ready-to-Eat Sandwich Supplier

SILVER SPRING, Md. -- The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA) , filed a complaint for permanent injunction against Rel's Foods Inc. of Oakland, Calif., seeking to stop the company from manufacturing, producing and selling adulterated food products.

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 last week in the U.S. District Court, Northern District of California, alleges Rel's has an extensive history of operating under unsanitary conditions. The complaint states Rel's produced and distributed sandwiches contaminated with Listeria. 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 infection.

The complaint also names Rel's Vice President Peder Scott Sorensen and two managers, Patrick O'Malley and Timothy E. Ault.

The complaint alleges FDA investigators 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, the CFDB embargoed and seized all in-process and finished products inside the facility.

These inspections also revealed the company repeatedly violated the current Good Manufacturing Practice 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.

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