The FDA has sent a warning letter dated September 25, 2020 to Dole Fresh Vegetables at 2959 Salinas Highway in Monterey, California, after failure to comply with preventive controls of thee Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. The product, HEB Tuscan Herb Chopped Salad Kit, was recalled in March 2020 for undeclared peanuts, wheat, soy, and tree nuts, four of the major food allergens.
The FDA states that the company said that the mislabeling occurred when the incorrect masterpack kit, which is the kit containing the dressing and other toppings, was “unintentionally used during the production of the salad.” The company also stated that the firm “did not have a robust enough verification process for product changeover.”
The warning letter states that the company “did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed packed or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm using an incorrect masterpack in your Tuscan Herb Chopped Salad Kit. This masterpack addition error caused your product to contain undeclared major food allergens.”
The company is told that they are responsible for making sure that the facility operates in compliance with applicable laws and should take “prompt action” to correct violations. In addition, the implementation of corrective actions will be verified during the next FDA inspection of the facility.
