For Immediate Release
November 21, 2014
UPDATE: On May 12, 2016, Judge Robert H. Cleland of the United States District Court for the Eastern District of Michigan entered a consent decree of permanent injunction against Scotty’s Incorporated, located in Detroit, and its owner Sandra J. Jackson. The judge’s ruling means that the U.S. Food and Drug Administration documented that the Defendants had violated the Federal Food, Drug, and Cosmetic Act by introducing adulterated food into interstate commerce. Previously, on March 28, 2016, the court granted the government’s Motion for Summary Judgment against Scotty’s, agreeing that the Defendants violated the FDCA in the past and there was a realistic danger of future violations, and that the Defendants had not raised a genuine issue of material fact with respect to either factor.
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.
Scotty’s has a history of manufacturing their ready-to-eat sandwiches under unsanitary conditions and failing to comply with the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
“Based on the company’s previous failure to maintain sanitation controls, the FDA is taking action to protect public safety,” said Melinda K. Plaisier, the FDA’s associate commissioner of regulatory affairs.
The FDA issued a Warning Letter to the company in 2009 for failing to have adequate controls and processes in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the business. The Warning Letter referenced at least two inspections and cited observations of unsanitary practices and conditions in the facility. In October 2010 and February 2014, FDA investigators documented the company’s failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. In addition, the defendants failed to make repairs and properly maintain equipment in the facility to prevent food from becoming adulterated.
The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA on November 21, 2014, in the U.S. District Court for the Eastern District of Michigan.
No illnesses have been reported to date associated with products from Scotty’s Incorporated, doing business as Bruce Enterprises and Bruce’s Fresh Products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
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.