The permanent injunction bans the Mill Stream Corporation, doing business as Sullivan Harbor Farm, from processing and distributing smoked fish products until the company demonstrates it has 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.

According to FDA, recent inspections found Sullivan Harbor Farm—a processor of vacuum packed, ready-to-eat fish products that sells primarily to wholesale customers in Maine, Massachusetts and Washington, DC—failed to control for Clostridium botulinum hazards in its fish products. Investigators also found evidence of rodent feces and mold at the facility. Previous FDA testing revealed the presence of Listeria monocytogenes in the plant environment and on a skinning machine.

 “The failure to plan for and control the presence of bacteria and neurotoxins commonly found in seafood-processing facilities can pose a significant risk to the public health,” says Benjamin Mizer, principal deputy assistant attorney, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to prevent the distribution of adulterated food.”