The FDA Warning Letter issued to a ready-to-eat prepared foods plant which included failure to renew its registration, lack of a seafood HACCP plan, and allergen and GMP concerns, carries a number of lessons for industry.
Food facilities are required to renew their FDA registrations on a bi-annual basis. As shown by this facility’s warning letter, failure to do so can elicit a citation or other consequence.
Although the facility processed fish/fishery products, it did not have a Seafood HACCP plan to control the hazards and had not conducted a hazard analysis. FDA also observed that there was a lack of controls including refrigerated storage which exceeded 41°F, which could permit proliferation of contaminating microorganisms and seafood toxins, if present. The citation was focused on the facility’s tuna salad sandwich, showing that a facility must have a HACCP plan even if producing only a single seafood product.
Because there was no allergen labeling on finished product covering the milk, soy, egg and fish ingredients, the facility was cited for misbranding violations. The inspector also observed insufficient cleaning of food contact surfaces, which could lead to cross-contact; and GMP concerns included live flies in the processing room.
Ensuring compliance with all regulations that are applicable to foods in your facility, and maintaining allergen and sanitation controls, are critical for the safety of your foods… and a lack thereof will lead to FDA citations when observed.
