FDA Takes Enforcement Action Against Rel's Foods Inc.
by Stephanie Kwisnek, U.S. Food and Drug Administration
Posted: 2009-10-29 17:29:36 EST

SILVER SPRING, Md., Oct. 8 /PRNewswire-USNewswire/ -- The U.S.Department of Justice, on behalf of the U.S. Food and DrugAdministration, has filed a complaint for permanent injunction againstRel's Foods Inc. (Rel's), of Oakland, Calif., seeking to stop thecompany from manufacturing, producing, and selling adulterated food products.

The complaint also names Rel's Vice President, Peder Scott Sorensen, andtwo managers, Patrick O'Malley and Timothy E. Ault. Rel's prepares,processes, and distributes a variety of ready-to-eat sandwiches toconvenience stores, deli markets, liquor stores, mini-marts, and gasstations 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 extensivehistory of operating under insanitary conditions. The complaint statesthat Rel's has produced and distributed ready-to-eat sandwichescontaminated with Listeria monocytogenes (L. mono). Listeriosis, theillness caused by L. mono, can cause fatal infections in young children,the elderly, and individuals with weakened immune systems, and pregnantwomen may suffer miscarriages or stillbirths as a result of theinfection.

The complaint alleges that FDA investigators have found L. mono insideRel's production facility on numerous occasions since 2002.Additionally, routine laboratory testing by the Department of Defenseand the California Department of Public Health, Food and Drug Branch(CFDB) found L. mono in the company's processing plant and finishedsandwiches. Based on recent laboratory analyses, CFDB has embargoed andseized all in-process and finished products inside the facility.

The FDA and CFDB inspections also revealed that the company repeatedlyviolated the current Good Manufacturing Practice (cGMP) requirements forfoods. Investigators found poor employee sanitation practices andinappropriately maintained facility and manufacturing equipment,including excessive condensation dripping onto food contact surfaces.

"Rel's lack of effective measures to bring its food processingoperations into compliance with the law poses a serious public healththreat," said Michael Chappell, the FDA's acting associate commissionerfor regulatory affairs. "The company's failure to comply with goodmanufacturing practice also demonstrates the potential for the companyto continue to manufacture contaminated products."

No illnesses have been reported so far from Rel's products. Individualswho have eaten the products and who experience symptoms such as highfever, severe headache, stiffness, nausea, abdominal pain, and diarrhea,should contact their health care professional.

Consumers can report problems with FDA-regulated products to theirdistrict office consumer complaint coordinator.

Source: U.S. Food and Drug Administration