Pharmacy News EU

To: FOOD, HEALTH, AND NATIONAL EDITORS
Contact: Rita Chappelle of FDA, +1-301-796-4672 or +1-240-753-8603, rita.chappelle@fda.hhs.gov
Products made under conditions that violated federal law
SILVER SPRING, Md., June 7 /PRNewswire-USNewswire/ 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.
(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO )
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 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.
"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 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.
For more information
Lifesoy Inc. – The FDA’s Inspections, Compliance, Enforcement, and
Criminal Investigations Web Page
Media Inquiries: Rita Chappelle, 301-796-4672 or Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
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