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Northland Vapor Company, LLC manufactured ready-to-eat gummy products containing Delta-8 THC that were determined to be adulterated due to containing unsafe food additives and being prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health. The FDA inspection of the Wonky Confections facility in Moorhead, Minnesota (conducted November-December 2022) identified multiple CGMP and sanitation deviations documented on Form FDA-483, which the company's December 2022 response failed to adequately address. The specific products cited—"Death by Gummy Bears" and "Wonky Weeds" gummy bear products—violated section 402(a)(2)(C)(i) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, making their introduction into interstate commerce illegal.