FDA WARNING_LETTER - Lipari Foods Operating Company, LLC. - April 16, 2024

The FDA issued a Warning Letter to JLM Manufacturing LLC for misbranded food products and violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The firm conducted three recalls in August and September 2023 due to mislabeling: IO Inspired Organics brand Organic Raw Walnut Halves & Pieces were mislabeled as cashews, raw filberts/hazelnuts were mislabeled as "JLM brand Roasted Salted Pecan Halves," and cashews were mislabeled as "IO Inspired Organics Raw Walnuts." These instances resulted in undeclared major food allergens (walnuts, filberts/hazelnuts, cashews) on product labels, constituting misbranding under section 403(w) of the Act [21 U.S.C. § 343(w)].

The FDA determined that JLM Manufacturing LLC failed to identify and implement adequate preventive controls for food allergens at the packaging/labeling step, as required by 21 CFR 117.135(a)(1) and (c)(2). While the firm provided documentation of updated policies, employee retraining, and amended production paperwork to include label retention samples and QA verification, the FDA will verify implementation during a future inspection. The letter requires a written response within 15 working days detailing corrective actions and prevention plans. Failure to comply may result in legal