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FDA flexes FSMA permanent injunction muscles for the first time

More than two years after sending a warning letter to the firm — and more than nine years after gaining the power to do so — the FDA has today, for the first time, issued a consent decree of permanent injunction against a firm and grower for violating public safety standards under the Produce Safety Rule.
The action regarding Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products, involves violations of the sprouts portion of the Produce Safety Rule, which is part of the 2011 Food Safety Modernization Act (FSMA).
“This action also follows several inspections conducted by the FDA (Food and Drug Administration), 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,” according to today’s announcement regarding the consent decree.
U.S. District Judge John Robert Blakey in the Northern District of Illinois entered the consent decree of permanent injunction, on Sept.15, between the United States and Fortune Food Product Inc., its majority owner Steven Seeto and its supervisor Tiffany Jiang.
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 operations may resume.
In the formal complaint against the business, the U.S. Department of Justice said the FDA staff conducted multiple inspections. They documented unsanitary conditions showing that sprouts and soy products may have become contaminated with filth or may have been rendered injurious to health.
“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,” according to the FDA statement.
The sprout specific portion of the Produce Safety Rule requires certain sprout operations to take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting. They must also 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.
No confirmed illnesses related to Fortune Food’s products have been reported to the FDA. 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.
About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any of the implicated   products and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.
Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.
Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.
Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.
(To sign up for a free subscription to Food Safety News, click here .)

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