FDA Takes Enforcement Action Against Ready-to-Eat Sandwich Manufacturer

Company allegedly failed to correct violations

SILVER SPRING, Md., Oct. 8 /PRNewswire-USNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

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.

Media Inquiries: Stephanie Kwisnek, 301-796-4737,
Stephanie.Kwisnek@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Stephanie Kwisnek of FDA, +1-301-796-4737, Stephanie.Kwisnek@fda.hhs.gov