June 7, 2010
Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products, has been ordered to stop making and distributing food products until it cleans up its act.
The order is part of a consent decree the company signed with the Food and Drug Administration, after inspections turned up unsanitary conditions at the plant. The company may resume operations once it show it is in compliance with FDA regulations.
Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The government's complaint further alleges that Lifesoy did not hold and store the foods under proper refrigeration conditions to prevent the growth of microorganisms.
U.S. District Judge Jeffrey T. Miller entered a consent decree of permanent injunction on June 2, 2010, against the company, and its owner, Long H. Lai. The consent decree permanently restrains and enjoins Lifesoy and Lai from directly or indirectly receiving, preparing, processing, packing, holding, and distributing any article of food, unless and until they come into compliance with the terms of the consent decree and the law.
"This action shows that the FDA will seek enforcement action against companies that continue to violate federal laws designed to protect the safety of the nation's food supply," said FDA Acting Associate Commissioner for Regulatory Affairs Michael Chappell. "Food facilities such as Lifesoy are required by law to register with the FDA and follow current good manufacturing practices and other laws, including maintaining a sanitary facility."
As part of the consent decree, Lifesoy must retain a qualified sanitation expert, with no personal or financial ties to the defendants, to develop and implement a written sanitation program to assure that the operations comply with current Good Manufacturing Practices. Before the company may reopen it must, among other things, receive FDA approval of its sanitation program and have the agency re-inspect the facility.
The government's complaint alleged that Lifesoy and Lai caused articles of food to be adulterated under federal law by preparing, packing, and holding foods in such conditions that the products may be rendered injurious to health or may have become contaminated.
The complaint further alleged that Lifesoy did not hold and store the foods under proper refrigerated conditions to prevent the growth of microorganisms.
Lifesoy was first inspected by the FDA in November 2007. The Agency attempted to help the company come into compliance with appropriate food safety laws, however Lifesoy failed to comply resulting in this action, the FDA said.
