U.S. District Judge Jon D. Levy of the district of Maine entered a consent decree of permanent injunction against Mill Stream Corporation, doing business as Sullivan Harbor Farm at the request of the FDA. This facility processes and sells vacuum packed, ready-to-eat fish products, including hot and cold smoked salmon, trout, and arctic char, and has a “long history of recurring violations,” according to the press release.
FDA inspectors found that the company did not control for Clostridium botulinum hazards in their fish products and did not comply with good manufacturing practice requirements as required by law. FDA inspectors found evidence of rodent feces and mold at the facility during inspections.
Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, said in a statement, “when a company repeatedly violates food safety laws and procedures they are putting the public at risk. It is our job at the FDA to protect the food supply and we must take action to ensure that food is safe for everyone.”
In addition to the botulism risk, FDA testing found Listeria monocytogenes in the plant environment and on a fish skinning machine at Sullivan Harbor Farm. This pathogenic bacterium can cause serious illness, including miscarriage and stillbirth in pregnant women. There is zero tolerance for any Listeria bacteria in ready-to-eat-foods. The FDA issued an Administrative Detention Order to the firm, which led to destruction and recall of products made by the company.
The decree requires the company and Ira Frantzman, its owner to “stop processing and distributing smoked fish products until they have taken specific steps to achieve compliance with the Federal Food, Drug and Cosmetic Act and the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The decree also prevents the Ironbound Restaurant from serving Sullivan Harbor Farm fish until the company is in compliance.