A soy products manufacturer that agreed to close its doors last November after Listeria contamination at its Chicago facility was associated with several illnesses last summer has accepted a consent degree outlining conditions it must follow if it ever wants to get back in business. Julia and Paul Trinh, individually and on behalf of Wholesome Soy Products Inc., along with their Foley & Lardner attorneys Nathan A. Beaver and John L. Litchfield, signed the agreement with the federal government late Friday, April 3. The agreement does not become binding until a federal judge signs it, which is likely to occur shortly. The agreement outlines in minute detail what the Chicago manufacturer will have to do if it wants to produce sprout, tofu, and soy products in the future. Earlier Friday, the Trinhs and Wholesome Soy Products Inc. were named as defendants in a complaint charging them with responsibility for shipping adulterated food through interstate commerce. Although the facility is closed down, government attorneys said there was nothing in place to stop the company from resuming production “without taking corrective actions.” In signing the consent degree, neither the Trinhs individually or through their corporate entity are admitting or denying any of allegations in the government’s complaint. They do, however, accept the government’s conditions should they opt to get back into business. In accepting the conditions, the Trinhs “represent to the Court” that they are currently shut down and not engaged in receiving, preparing, processing, packing, holding or distributing any type of food at, or from, any location. If they want to try and resume operations, they must give the U.S. Food and Drug Administration (FDA) written notice 90 days in advance of the date they want to restart any activity. Also, Wholesome Soy Products cannot legally resume without first having its facilities inspected by FDA. The notice and inspection requirements don’t apply to a corporation in which one or both of the Trinhs are an owner, director, officer, or manager, but each of them must notify FDA in writing within 14 days if they become employed elsewhere in the food industry. Once signed by a federal judge, the consent degree applies to anyone who might want to use the facility at 1150 W. 40th St. in Chicago for food manufacturing. To reopen will require engaging the services of an independent laboratory to test for Listeria monocytogenes, hiring an independent sanitation and food safety expert, and following other specific steps contained in the 20-page agreement. Where FDA is involved with the start-up requirements, the manufacturer will pay all of the government costs at rates of $89.35 per hour for inspection work and $107.09 an hour for analytical or review work. FDA’s concerns about Wholesome Soy Products go back to last August and September when inspections of the facility led to the company’s voluntary recall of mung bean sprouts over Listeria contamination. Five Listeria illnesses earlier last summer were then connected to contamination of the Chicago facility.
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