The consent decree, which follows a complaint for permanent injunction filed by the Department of Justice (USDOJ) on behalf of the FDA, prevents Yamaya USA Inc. and its president Daigo Irifune manufacturing or distributing fish or fish products until it improves conditions at its seafood processing facility.
The FDA complaint alleged that the company failed to comply with the FDA’s Current Good Manufacturing Practice (CGMP) and Seafood Hazard Analysis Critical Control Point (HACCP) regulations.
Signed at the US District Court for the Central District of California, the agreement follows a FDA warning letter in relation to conditions at the plant and a multi-state product recall.
Food safety requirements
“Under the terms of the consent decree, Yamaya must meet several FDA food safety requirements before it can resume manufacturing and distributing fish and fish products,” said a FDA statement.
“The consent decree also requires that the firm destroy all foods that are currently in process or ready for shipment, and it must clean and sanitise the facility until laboratory results confirm no further Listeria monocytogenes contamination.”
“The firm must also hire a sanitation and food safety expert to develop and implement a Listeria monitoring program and a HACCP plan, and it must hire an outside auditor to conduct inspections of the facility at least once every three months for three years and once every year for two years after that, for a total of five years of auditing inspections,” the FDA added.
Despite the FDA actions, no illnesses have been reported to-date implicating Yamaya products.
A FDA warning letter to the company, dated 19 July 2011, reported “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations and the Current Good Manufacturing Practice regulation for foods.
“Accordingly, your Capelin Roe and Pollack Roe products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” said the FDA warning letter.
A batch of the company’s Capelin Roe product was recalled later that year over fears it had “the potential to be contaminated with Listeria monocytogenes.”
“The recall was the result of a microbiological sampling of the facility by the FDA which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continues their investigation as to what caused the problem,” said the October 2011 issued recall.
Earlier this year, the FDA filed a similar injunction against California-based fish processor Fujino Enterprises Inc. over botulism and listeria contamination fears.
If granted, the injunction will permit the FDA to permanently prevent the company processing and distributing its fresh and smoked fish and fish products.