The United States filed a complaint to stop a seafood processor in Monroe, Washington, from processing and selling adulterated seafood products, the Justice Department announced.

In a civil complaint for permanent injunction filed March 9, 2022 at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that Diane Zollinger, through her business, Felix Custom Smoking, violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing adulterated ready-to-eat seafood products, including fish jerky and cold- and hot-smoked salmon. According to the complaint, Zollinger sells products directly to consumers from her business and at farmers’ markets. She also provides custom processing for fisherman and other wholesalers.

The complaint, which was filed in the U.S. District Court for the Western District of Washington, alleges that FDA inspectors visited Zollinger’s facility in 2021 and found a significant infestation of flies and other filthy conditions that can create an ideal environment for the growth of harmful bacteria, such as Listeria monocytogenes. Food contaminated with Listeria monocytogenes can cause symptoms such as diarrhea and vomiting in healthy adults. For vulnerable consumers—including pregnant women, the elderly and the immune-compromised—Listeria monocytogenes can cause more serious effects, such as stillbirths, miscarriages, and death.

The complaint further alleges that FDA inspectors took multiple samples at Zollinger’s facility and confirmed the presence of Listeria monocytogenes in and around food preparation areas. According to the complaint, genetic testing showed the same strain of Listeria monocytogenes had been present in the facility since at least 2018, and a sample of seafood from one of Zollinger’s customers also showed the same strain of Listeria monocytogenes. FDA issued a public health alert warning against purchasing or eating Felix Custom Smoking seafood. The United States now seeks an injunction that would require Zollinger to eliminate Listeria monocytogenes at her facility, make sanitation improvements and comply with federal food safety regulations before processing or distributing any more seafood.

“Food processors must ensure the safety of their products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with FDA to stop the distribution of contaminated food.”

“The Western District of Washington has seen all too vividly what happens when adulterated food makes it into our food supply,” said U.S. Attorney Nick Brown for the Western District of Washington. “Whether it is Escherichia coli in ground beef or orange juice or, as alleged in this case, dangerous bacteria in smoked salmon, we count on the FDA’s inspectors to keep us and our families safe.” 

Trial Attorney Sarah Williams of the Justice Department’s Consumer Protection Branch is handling the case with the assistance of Assistant U.S. Attorneys Kerry Keefe and Kayla Stahman in the Western District of Washington and Assistant Chief Counsel Lauren Fash of the FDA’s Office of the Chief Counsel.

The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove by a preponderance of the evidence.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.