FDA WARNING_LETTER - Modern Macaroni Co Ltd - April 28, 2014

On April 16-28, 2014, the FDA inspected Modern Macaroni Co. Ltd.'s facility in Honolulu, Hawaii, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). As a result, products like Hula Brand Hana Ebi (artificially colored shrimp flakes) and Hula Brand Fun Chow noodles are deemed adulterated.

Key violations include: - **HACCP Deficiencies:** The firm lacks a HACCP plan for Hula Brand Hana Ebi to control allergen hazards (crustacean shellfish) and food/color additive hazards (sulfiting agents and FD&C Yellow #5). A sample of green Hula Brand Hana Ebi contained 208 ppm of sodium bisulfite, which was not adequately controlled or declared. - **Sanitation Monitoring:** The firm failed to sufficiently monitor the cleanliness of food contact surfaces and maintenance of handwashing/toilet facilities. Observations included a caked grinder, worn and uncleanable wooden drying trays, and no warm water in the employee restroom. - **CGMP Violations:** Equipment and utensils, such as wooden hanging rods and drying trays for Hula Brand Fun Chow noodles, were not adequately cleanable and appeared heavily worn. The drying room for these noodles was dusty and debris-laden,