Litehouse, Inc. – FDA Warning Letter, May 21, 2024
The FDA issued a Warning Letter to Litehouse Drive, Sandpoint, ID, on November 29, 2023, for misbranded Simple Truth brand Plant Based Ranch Dressing. The product, with lot code 1713802052623 and best by date “05 23 23”, was recalled on April 19, 2023, due to undeclared soy, a major food allergen.
Investigation revealed that Plant Based Ranch Dressing containers were filled with Caesar Dressing, which contains soy, because work-in-progress bulk containers were mislabeled. This constitutes misbranding under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], as the label failed to declare soy. The firm has a history of two similar recalls in 2021 involving mislabeled products and undeclared allergens.
The FDA noted 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), requiring preventive controls for undeclared allergens. The failure to comply with these provisions is prohibited by section 301(uu) of the Act.
Litehouse provided corrective action information on June 6, 2023, including updated task instructions and
ID · 1527ccd3-512a-4d6d-bcdf-64e0affd3bc8
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