FDA WARNING_LETTER - Knickerbocker 365, Inc. - September 12, 2023

The FDA issued a Warning Letter to Mr. Hanna regarding misbranded Knickerbocker Homestyle Hamburger Buns and violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations (21 CFR Part 117).

On September 12, 2023, the firm recalled Knickerbocker Homestyle Hamburger Buns (lot codes I31C, J01C, J02C, J06C, J07C, J08C, J09C, & J11C, UPC 611625100206) after discovering undeclared milk. This was prompted by a Michigan Department of Agriculture and Rural Development (MDARD) inspection on September 12, 2023, following a customer's allergic reaction to milk after consuming the product.

The firm reformulated the buns to include milk powder but failed to update the packaging to declare milk, a major food allergen, on products manufactured between August 31 and September 11, 2023. This resulted in misbranding under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)].

Furthermore, the firm failed to identify and implement preventive controls for undeclared allergens at the packaging/labeling