A Michigan food processing facility is manufacturing tuna salad sandwiches without having a seafood Hazard Analysis and Critical Control Point (HACCP) plan, according to the U.S. Food and Drug Administration.

In a recently released June 2 warning letter sent to Fiesta Gourmet, located in Dearborn, FDA said the failure by a processor of fish or fishery products to have and implement a HACCP plan renders the fish or fishery products produced in the facility to be considered “adulterated” under provisions of the Federal Food, Drug, and Cosmetic Act.

“Accordingly, your tuna salad sandwiches are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the warning letter said.

FDA said Fiesta Gourmet’s significant violations included:

– “You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b).  However, your firm does not have a HACCP plan for your refrigerated tuna salad sandwiches to control the food safety hazards of histamine formation, allergens, and pathogen growth.

– “You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b) to comply with 21CFR 123.11(c).  However, your firm did not maintain any sanitation control records in the eight key areas of sanitation that document sanitation monitoring and correction of sanitation deficiencies for the tuna salad sandwiches manufactured at your firm.”

FDA told Fiesta Gourmet that it must “promptly correct these violations.”  If it does not, the agency said it might have to take further action, which could include seizing Fiesta Gourmet’s products and/or enjoining it from operating.

The Michigan company was given 15 working days to respond to the warning letter.