The U.S. Food and Drug Administration sent warning letters to five food facilities last week. Valley Foods of Youngstown, OH, received a warning letter because it did not have a Hazard Analysis and Critical Control Point (HACCP) plan for tuna salad to control the food safety hazards of scombrotoxin (histamine) formation and allergens. The company argued that its tuna salad processing prior to retorting is not a hazard because it does not exceed the critical limit time/temperature parameter standards, but FDA responded that the point is “irrelevant to whether or not a critical control point exists. Critical control points exist wherever control can be applied to prevent, eliminate, or reduce a food safety hazard. When critical control points exist, they must be controlled with a written HACCP plan.” Evangel International Foods of Pasadena, TX, had “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the firm’s dried catfish products were considered adulterated, meaning they had been “prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.” Some of the violations detailed in the letter included a lack of or inadequate critical control points, failing to monitor or maintain certain sanitation monitoring records, and failing to monitor prevention of cross-contamination from insanitary objects, protection of food, food packaging material, food contact surfaces from adulteration and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements. Shell egg production facility Sixdog Investments of Wellington, CO, had “significant violations” of the Prevention of Salmonella Enteritidis (SE) regulation. The company did not have documentation for certain pullets and chicks that ensures they were purchased from SE-monitored breeder flocks and did not raise the pullets under SE monitored conditions, including environmental testing. Sixdog also failed to implement its SE prevention plan in terms of leaving a poultry house vacant for a certain period of time after sanitation and disinfection; pests, bird nesting and potential harborage areas in barns; holding and transporting eggs at or below 45 degrees Fahrenheit beginning 36 hours after time of lay; and adequate biosecurity measures. FDA also warned the company about the prevention plan not providing threshold levels for unacceptable fly activity and unacceptable rodent activity in poultry houses. “Your eggs were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” the letter read. FDA cited Vietti Acquisitions’s Nashville low-acid canned food (LACF) manufacturing facility for deviations from the Emergency Permit Control regulation, the low-acid canned food (LACF) regulation and the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation. According to the letter sent Nov. 3, the firm, which manufactures products like hot dog chili sauce and vegetable soup, failed to provide FDA with a description of the processing changes, to test the thermometers for accuracy against a known accurate standard thermometer upon installation and at least once a year afterward, to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated, to construct their facility in a manner as to prevent drip and condensation from contaminating food and food-packaging materials, to clean non-food-contact surfaces of equipment frequently and to store raw materials in a manner that minimizes deterioration. In addition, employees failed to effectively wear appropriate hair restraints. The strawberry and mango ice creams produced by Helados La Tapatia of Fresno, CA, were considered adulterated and misbranded because of color additives. The strawberry ice cream label declared “red color” which is “a non-permitted color additive” and the mango ice cream declared “yellow food colorings” rather than Yellow No. 5 specifically. FDA also found the company’s Natural Creamy Fruit Bar All Natural Esquimal product and Natural Creamy Fruit Bar All Natural Cookies ‘n Cream product to be misbranded – predominately because of differences between what is on product labels and what is actually included in formulation sheets. There were other things missing from these products’ labels such as major food allergen information. In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food safety laws and regulations, to correct violations cited in the letters and to prevent their recurrence. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.