Sandwich firm hit with FDA action
A complaint filed by the Department of Justice names Sandra Jackson as co-owner and manager of the firm which does business as Bruce Enterprises and Bruce’s Fresh Products.
Scotty’s has a history of manufacturing ready-to-eat sandwiches under unsanitary conditions and failing to comply with the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations, said the FDA.
However, the agency added that no illnesses have been reported associated with the products.
“Based on the company’s previous failure to maintain sanitation controls, the FDA is taking action to protect public safety,” said Melinda Plaisier, the FDA’s associate commissioner of regulatory affairs.
FDA warning letters
The FDA issued a warning letter in 2009 for failing to have adequate controls and processes to minimize risk of contamination and for not having a written HACCP plan for the tuna salad sandwiches it prepares.
Tuna that is not chilled rapidly or stored at sufficiently lower temperatures is at increased risk of scombrotoxin.
FDA referenced at least two inspections and cited observations of unsanitary practices and conditions in the facility.
In October 2010 and February 2014, FDA found failure to manufacture, package and store food under conditions and controls to minimize potential for growth of microorganisms and contamination.
However, according to the Detroit News, Jackson said her company has not sold any seafood in the last year to year-and-a-half.
Jerry Moore, Jackson’s attorney, said the safety of the product is not the issue but the working method has to be in writing and meet FDA regulations.
Written HACCP plan concerns
The complaint alleges that the company failed to implement a written HACCP plan for handling seafood and minimizing the potential for harmful contamination in the tuna sandwiches.
According to the complaint, FDA has performed five inspections of the defendants’ facility since 2006 and found insanitary practices and/or seafood HACCP violations every time.
These inspections revealed the RTE sandwiches are adulterated as set out by the Food, Drug, and Cosmetic Act.
FDA’s most recent inspection between January 14 and February 6 found the defendants failed to have and implement an HACCP plan for food safety hazards reasonably likely to occur.
There were also no sanitation control records documenting the safety of water used at the facility; utensils and equipment coming into contact with food; exclusion of pests from the facility; and control of employee health conditions, said the complaint.
“Seafood poses well-known risks when it is transported from ship to shore, but these risks can be effectively mitigated if companies handling seafood take proper precautions,” said Joyce Branda acting assistant attorney general of the Justice Department’s Civil Division.
