News & Events
FDA NEWS RELEASE
For Immediate Release: Aug. 2, 2010
Media Inquiries: Ira Allen, 301-796-5349, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
United States Seeks Permanent Injunction Against New York Food Processor
Listeria contamination, other repeated violations, prompt FDA action
The U.S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against NY Gourmet Salads, Inc., a processor of ready-to-eat deli salads, seafood salads, and cream cheeses in Brooklyn, N.Y., and Leonard F. Spada, the company's president.
The complaint, filed July 30 in the U.S. District Court for the Eastern District of New York, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by introducing into interstate commerce food that was prepared, packed, or held under insanitary (unsanitary) conditions and that may have become contaminated with filth or may have been rendered injurious to health.
FDA inspections have documented insanitary conditions at NY Gourmet's facility and a failure to follow applicable FDA regulations concerning the production of food and seafood products. Although the company promised to address and correct deficiencies following inspections in 2006, 2007, and 2009, the FDA's most recent inspection in March 2010 confirmed that the company continued to operate without adequate controls.
The complaint notes that recent FDA testing has found Listeria monocytogenes (L. mono) throughout the defendants' facility and in a sample of finished product. The complaint also says that the strain of L. mono found in a sample of the defendants' chickpea salad in 2010 was indistinguishable from the strain of L. mono found in the defendants' facility during a 2009 inspection, indicating that the L. mono had likely formed a lasting presence in the defendants' facility.
L. mono bacteria cause the disease listeriosis, which can be serious or even fatal for high-risk individuals such as unborn babies, newborns, and those with impaired immune systems. The most serious forms of listeriosis can result in meningitis and septicemia. Pregnant women may contract flu-like symptoms from listeriosis, and complications from the disease can result in miscarriage, or septicemia in the newborn.
“The continued presence of L. mono in a food processing facility is a particularly significant public health risk,” said Michael A. Chappell, acting associate commissioner for regulatory affairs. “In this case, the L. mono was not only found in the facility, but later turned up in a sample of the firm's food. We will not allow food producers to put consumers at risk by repeatedly breaking promises to clean up their facilities.”
The company sells its products to customers in New York and New Jersey, including a New Jersey gourmet supermarket with locations in Brick and Freehold, and an airline caterer in Jamaica, N.Y.
“Based on their longstanding pattern of conduct, defendants, unless restrained by order of this court, will continue to manufacture and distribute articles of food in violation” of the Federal Food, Drug and Cosmetic Act, the complaint said.