FDA Busts Lifesoy for Sanitary Practices

WASHINGTONTwo years ago, soy product manufacturer Lifesoy Inc. received a warning letter from FDA concerning insanitary conditions and food GMP (good manufacturing practice) violations found during an inspection of the companys food processing facility. The company failed to address the concerns sufficiently, so on June 2, 2010, a federal judge issued Lifesoy a consent decree, requiring the company to cease its manufacturing and distributing activities until it registers with FDA and complies with federal food laws (i.e. Title 21 of the Code of Federal Regulations (CFR) Part 110).

The San Diego-based manufacturer and its owner, Long H. Lai, face allegations they failed to store food in a manner to protect from spoiling, and did not safeguard foods from numerous contaminations, including dirty water, pests and unclean workers. Specifically, sweetened soy milk, unsweetened soy milk, fried tofu, fresh tofu, and fresh tofu pudding were not kept refrigerated either in-house or in-transit. Also, inspectors observed an employee splashing dirty cleaning water into a vat of processing food, in addition to numerous pest control failures involving cats, rodents and insects. FDA further accused the company of failing to ensure proper hygiene practicesincluding hand-washing and food consumption in processing areasfor employees with direct contact with processing food.

 Todays action shows that the FDA will seek enforcement action against companies that continue to violate federal laws designed to protect the safety of the nations food supply, said Michael Chappell, acting associate commissioner for regulatory affairs FDA. 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.

The consent decree requires Lifesoy to retain a qualified sanitation expert, with no personal or financial ties to the defendants, who must develop and implement a written sanitation program to bring the company into compliance with GMPs. FDA must approve Lifesoys sanitation program and re-inspect the facility before the company can restart its operations.