FDA+Cases


 * FDA Takes Action Against California Soy-Product Manufacturer Lifesoy**
 * Products made under conditions that violated federal law**

Lifesoy Inc., a San Diego-based manufacturer of ready-to-eat soy products cited by the U.S. Food and Drug Administration for preparing, packing, and holding articles of food under insanitary conditions, has entered into a consent decree of 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.

Lifesoy made sweetened and unsweetened soy milk, fried tofu, fresh tofu, soybean pudding, and other soy products for human consumption. The governmentâ€™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 Mr. 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.

â€œTodayâ€™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 nationâ€™s food supply,â€ said FDA Acting Associate Commissioner for Regulatory Affairs Michael Chappell. â€œFood 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.â€

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 governmentâ€™s complaint alleged that Lifesoy and Mr. 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.