Following an inspection of a sprouting and noodle facility in early 2024, a 483 was issued. After FDA reviewed the firm’s response, a warning letter was issued because the facility still lacked a hazard analysis, with no identification of allergens as a potential hazard despite the production of noodle varieties with different allergen profiles; mycotoxins not identified as a potential hazard despite the use of wheat flour; and metal not identified as a potential hazard despite the cutting operations in the plant. There was no metal detector.
Additionally, the company’s failure to accurately label the ingredients in products, including the lack of declaration of major food allergens, specifically wheat, was a significant violations of the labeling regulations for foods. The failure to declare an ingredient or correctly label an allergen is a misbranding of the product.
