FDA has announced 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.
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. 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 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.
The 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. It requires the defendants to, among other things, take corrective actions and notify FDA before such operations may resume.
According to the complaint filed by the U.S. Department of Justice on behalf of the agency, 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.
FDA is not aware of any confirmed illnesses related to Fortune Food’s products.