Knickerbocker 365, Inc. – FDA Warning Letter, Sep 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
ID · 5d1f2f2e-f45d-42d1-8ae3-c8342aa52c5b
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.