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The U.S. District Court for the Eastern District of Michigan entered a permanent injunction against Scotty’s Incorporated (Scotty’s), of Detroit, Michigan, and its co-owner and manager, Sandra J. Jackson, to prevent the distribution of adulterated ready-to-eat sandwiches, the Department of Justice announced today.
The department filed a complaint on Nov. 21, 2014, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, Scotty’s, which does business as Bruce Enterprises and Bruce’s Fresh Products, prepares and distributes ready-to-eat (RTE) sandwiches, including RTE tuna salad sandwiches. According to the complaint, the company’s sandwiches have been prepared, packed or held under insanitary conditions and the company failed to follow the Hazard Analysis and Critical Control Point (HACCP) regulations for their tuna processing. The complaint alleged that the company’s RTE sandwiches are primarily sold to local police departments and retail customers, such as convenience stores and gas stations, in Michigan and Ohio.
The permanent injunction followed a March 28, decision by the district court that Scotty’s had violated the Federal Food, Drug and Cosmetic Act (FDCA), including a finding that the company’s sandwiches were adulterated.
“The American public needs to have the confidence that food in the marketplace is safe to eat,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “Insanitary conditions at food processing facilities can pose well-known risks to consumers, but those risks can be effectively mitigated if companies preparing food take proper precautions.”
The district court’s March 28 decision concluded that FDA documented multiple violations of current good manufacturing practices at the company, including: mold-covered ceiling tiles in the walk-in cooler where defendants stored sandwiches; employees touching non-food contact surfaces, including those near the trash, before handling food products without washing their hands; and placing plastic bakery racks holding bread buns directly on the floor and in an alley near the trash and then moving the racks to a production table without being cleaned.
The district court also found that defendants did not have a HACCP plan in place. Federal regulations require processors of fish and fishery products, such as the company here, to conduct or have conducted for it a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed and to identify the preventive measures that the processor can take to control these hazards. Whenever such an analysis reveals one or more food safety hazards that are likely to occur, a processor is required to have and implement a written HACCP plan.
Under the permanent injunction, defendants cannot receive, prepare, process, pack, hold and distribute RTE sandwiches until they take a number of remedial steps. These steps include, among other things, submitting a written sanitation program covering all of their operations to ensure that they comply with the FDCA. Defendants must also submit a written HACCP plan for each type of seafood received, prepared, packed, held, or distributed by them for which food safety hazards are identified. In addition, defendants must submit employee training programs on all foodborne hazards, including the sanitation control program and a plan to destroy all finished and in-process RTE sandwiches in their custody, control or possession. Defendants must also wait until FDA notifies them that the defendants appear to be in compliance with specific remedial actions set forth above, the FDCA and its implementing regulations.
The government is represented by Trial Attorney Ann Entwistle, of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel Jennifer Kang, of the U.S. Department of Health and Human Services’ Office of General Counsel-Food and Drug Division and Assistant U.S. Attorney Peter Caplan of the Eastern District of Michigan.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of Michigan, visit its website at https://www.justice.gov/usao-edmi.