Gilster-Mary Lee Corporation – FDA Warning Letter, Apr 4, 2023

The FDA issued a Warning Letter to Gilster-Mary Lee on August 28, 2023, concerning their recalled “HyVee” brand Hamburger Chili Macaroni Skillet Meal. The product was deemed misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(w)] because its label failed to declare milk, a major food allergen. This mislabeling occurred when incorrect cartons for "Hamburger Chili Macaroni Skillet Meal" were used for "Hamburger Cheeseburger Macaroni Skillet Meal," which contains milk. The firm initiated a recall on March 24, 2023, following customer notification. The investigation revealed that a line supplier mistakenly provided the wrong cartons, and a lab technician failed to verify their accuracy. This incident is part of a pattern, as the firm has had three other allergen-related mislabeling recalls since 2019. The letter highlights that the firm's facilities are subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), which mandates preventive controls for undeclared allergens (21 CFR 117.135(a)(1) and (c)(2)). Gilster-Mary Lee has proposed corrective actions, including employee re-training and a new procedure requiring production line operators to verify packaging components for every brand change. The FDA will verify these actions during a future inspection. The firm must respond within 15 working days, detailing corrective steps, recurrence prevention, and supporting documentation, to avoid potential legal actions such as seizure or injunction.