The seafood processing and food manufacturing facility in Honolulu owned by Modern Macaroni Co. Ltd was inspected Dec. 6-13, 2016. Serious violations were found, which the FDA says renders the fish or fishery products from the facility to be adulterated.

The agency notified the company about the violations in a Feb. 23 warning letter, which was recently made public. The violations fell into two categories — seafood Hazard Analysis and Critical Control Points (HACCP) and Current Good Manufacturing Practices (CGMP).

FDAWarningcolor_406x250In the warning letter, the Food and Drug Administration said Modern Macaroni does not have a HACCP plan for its “Hula Brand Hana Ebi (artificially colored shrimp flakes) to control the food safety hazards of undeclared allergens (crustacean shellfish) and food and/or color additives (Sulfiting agents and FD&C Yellow #5).”

Modern Macaroni did respond in writing about the HACCP issues after the inspection. The FDA considered the response inadequate.

“We acknowledge receipt of your response, dated Dec. 26, 2016. In your letter, you agree that your firm has no HACCP plan in place. You included a statement that you will seek ‘further information regarding obtaining this HACCP plan’ for your firm; however, your response is not adequate,” the warning letter states. “You did not provide a timeframe of when a HACCP plan will be established and implemented, and your response does not provide assurances that your firm will process this product under an adequate HACCP plan.”

FDA also raised concerns about the condition and cleanliness of food contact surfaces, maintenance of hand-washing and toilet facilities, and the presence of pest excrement in the shrimp drying room. Termites and pests were also addressed in FDA’s details of CGMP violations.

“In your Dec. 26 response, you stated you plan to insert an acrylic-type of material inside the wooden crates and that you will cover the exposed sides and bottom of the wooden racks and wooden dowels with plastic, while you consider replacing the wooden dowels with plastic or PVC pipes,” FDA’s San Francisco district office wrote in the warning letter.

“We remind you that it is your responsibility to ensure the materials you use in food production are suitable and appropriate as direct food-contact surfaces and are maintained in acceptable condition and adequately cleaned.”

The warning letter says the company should not consider it to be a complete list of  violations. The company has 15 working days to the FDA compliance branch in San Francisco.

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