A California manufacturer/distributor of soymilk, fried tofu, fresh tofu, soybean pudding, and other ready-to-eat soy products has agreed to go out of business and try again.

San Diego-based Lifesoy Inc. cannot, under terms of a consent degree of permanent injunction, manufacture or distribute any more soy products for human consumption until it figures out how to do it the right way.

Lifesoy must start anew by registering as a food manufacturer with the U.S. Food and Drug Administration (FDA) and then demonstrate that it will comply with federal laws regarding sanitary practices.

FDA cited Lifesoy for preparing, packing, and holding food items under insanitary conditions, and sought the permanent injunction in the U.S. District Court for the Southern District of California.

The consent decree requires Lifesoy to stop manufacturing and distributing food products until the company registers with the FDA and complies with federal laws regarding sanitary practices.

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 on June 2 entered a consent decree of permanent injunction 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.

“Today’s 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.

The FDA first inspected Lifesoy 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.