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FDA NEWS RELEASE

For Immediate Release: March 28, 2014
Media Inquiries: Juli Putnam, 240-402-0537, juli.putnam@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA orders Wash.-based smoked seafood manufacturer to cease operations

The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.

 
The order follows the FDA’s analysis of environmental samples collected during its most recent inspection of the company’s facility, which confirmed the presence of Listeria monocytogenes (L. mono) in the facility, including in food processing and storage areas.
 
Jensen’s Old Fashioned Smokehouse Inc. is subject to a consent decree of permanent injunction, which was entered by the United States District Court for the Western District of Washington in 2001. Under the terms of the consent decree, the company agreed to comply with requirements to control food safety hazards and ensure that its products are not adulterated.  
 
The findings of the FDA’s most recent inspection establish that food in the company’s facility is adulterated and led the FDA to issue the order to cease operations under the terms of the consent decree.
 
In order to resume operations, Jensen’s must meet several requirements, including thoroughly cleaning and sanitizing the facility and hiring an expert to develop a Sanitation Standard Operation Procedure and an environmental microbial monitoring program for L. mono. Jensen’s must also test representative samples of all vacuum-packaged smoked fishery products on hand at the company for L. mono and provide the results to the FDA.
 
Jensen’s processes smoked fish products and distributes or sells them in its retail store, online and through other businesses in Washington, Oregon and California.
 
L. mono can cause a serious illness called listeriosis, which can be fatal, especially in certain high-risk groups. These groups include older adults, people with compromised immune systems and certain chronic medical conditions (such as cancer) and unborn babies and newborns. In pregnant women, listeriosis can cause miscarriage, stillbirth and serious illness or death in newborn babies, though the mother herself rarely becomes seriously ill. To date, no illnesses have been reported to the FDA associated with Jensen’s smoked seafood products.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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