FDA WARNING_LETTER - Pero Family Farms Food Company, LLC - August 18, 2020

The FDA issued a Warning Letter to Pero Family Farms Food Company, LLC, on August 10, 2020, following a recall initiated by the firm on March 10, 2020. The recall of Zucchini Spiral Pesto Side Dish Kits was prompted by a customer notification that the product was mislabeled with a sweet teriyaki veggie rice back panel, failing to declare major food allergens: egg and milk.

The FDA determined that the recalled product was misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)] due to the undeclared allergens. Furthermore, the firm failed to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). Specifically, the firm did not identify and implement preventive controls, such as food allergen controls at the labeling step, to significantly minimize or prevent the hazard of undeclared allergens, as required by 21 CFR 117.135(a)(1) and (c)(2).

The letter emphasizes that egg and milk are "major food allergens" under section 201(qq) of the Act [21 U.S.C. § 321(qq)], and their unde