George DeLallo Company, Inc. – FDA Warning Letter, May 4, 2021

The FDA issued a Warning Letter to DeLallo Way on March 30, 2021, regarding misbranded Holiday Cookie Platter and Provolini Antipasti products manufactured at their Mount Pleasant, PA facility. The products were found to be misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(w)] because their labels failed to declare major food allergens: pecans in the Holiday Cookie Platter and milk in the Provolini Antipasti. These incidents stemmed from incorrect labels being applied during production. The FDA emphasized that the facility is subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The misbranding indicates a failure to implement adequate preventive controls to prevent undeclared allergens, which is prohibited by section 301(uu) of the Act, specifically referencing 21 CFR 117.135(a)(1) and (c)(2). DeLallo Way provided corrective actions, including enhanced label selection and verification by Quality Control personnel, and a restructuring of Quality Assurance responsibilities. The FDA will verify the implementation of these corrective actions during a future inspection. The firm is required to respond within 15 working days, detailing specific steps taken to address the violations and prevent recurrence, with potential legal action, including seizure and injunction, for non-compliance.