FDA NEWS RELEASE
For Immediate Release: April 11, 2012
Consumer Inquiries: 888-INFO-FDA
Department of Justice enters consent decree with California seafood processor
Company agrees to multiple actions to correct FDA food safety violations
A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to be contaminated with Listeria monocytogenes (L. mono) bacteria.
According to a complaint for permanent injunction filed by the Department of Justice on behalf of the FDA, Yamaya USA, Inc., of Torrance, Calif., and its president, Daigo Irifune, prepared and processed fish and fish products under conditions that contributed to widespread L. mono contamination in their facility
The complaint alleges that Yamaya also failed to comply with FDA’s current good manufacturing practice (CGMP) and seafood hazard analysis critical control point (HACCP) regulations.
Listeriosis, a serious infection usually caused by eating food contaminated with L. mono, is an important public health problem in the United States. This pathogen causes nearly 2,500 cases of listeriosis per year in the United States. Although harmless in most healthy people, listeriosis poses a serious threat to pregnant women, newborns and individuals with weakened immune systems. However, rarely, persons without these risk factors can also be affected.
“Food producers have an obligation to provide safe food for U.S. consumers,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “When the foods they produce are potentially unsafe, FDA takes corrective action to protect the public health.”
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. 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 sanitize the facility until laboratory results confirm no further L. mono 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 consent decree was signed by Judge John F. Walter of the U.S. District Court for the Central District of California on April 5, 2012.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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