FDA issues first injunction under Produce Safety Rule to Illinois-based Food Manufacturer for Repeated Food Safety Violations

Monday, September 21, 2020

September 15, 2020

The FDA (U.S. Food and Drug Administration) announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

FDA reports the action marks the first consent decree of permanent injunction against a firm or grower for violating public safety standards under the Produce Safety Rule enacted under the Food Safety Modernization Act of 2011. The Produce Safety Rule requires, among other things, that covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting; test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens; test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes; and take corrective actions when needed.

This action also follows several inspections conducted by the FDA, which found that the company failed to comply with Produce Safety and Current Good Manufacturing Practice regulations. In July 2018, the FDA sent a warning letter outlining food safety violations.

U.S. District Judge John Robert Blakey in the U.S. District Court for the Northern District of Illinois entered the consent decree of permanent injunction on September 15, 2020 between the U.S. and Fortune Food Product, Inc., its majority owner Steven Seeto and its supervisor Tiffany Jiang.

“Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin. “This action demonstrates the agency’s commitment to pursuing and taking swift action against those who repeatedly disregard these food safety standards and distribute adulterated foods.”

The consent decree prohibits the defendants from growing, harvesting, packing and holding sprouts and soy products at or from their facility, or any other facility, until certain requirements are met. The consent decree requires the defendants to, among other things, take corrective actions and notify the FDA before such operations may resume.

According to the complaint filed by the U.S. Department of Justice on behalf of the agency, the FDA conducted multiple inspections and documented insanitary conditions showing that sprouts and soy products may have become contaminated with filth or may have been rendered injurious to health.

The FDA is not aware of any confirmed illnesses related to Fortune Food’s products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with this or any FDA-regulated product.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

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