Attorneys in the U.S. Department of Justice and U.S. Department of Health and Human Services have filed a lawsuit against Wholesome Soy Products to permanently enjoin the company, its owner and manager from causing food to become adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) after government agencies allegedly linked the company’s facilities to a 2014 outbreak of Listeria in Michigan and Illinois. United States v. Wholesome Soy Prods., Inc., No. 15-2974 (N.D. Ill., filed April 3, 2015).
Wholesome Soy manufactured and sold mung bean and soybean sprouts until November 2014, when the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and state agencies allegedly traced incidents of Listeria infections observed in five people to the Wholesome Soy facility. An FDA laboratory allegedly found Listeria in 28 samples—including two from mung bean sprouts—taken during a September 2014 inspection of Wholesome Soy’s plant and in nine samples from an October 2014 inspection.
The complaint further alleges that FDA inspections of the company’s manufacturing facility in October 2014 revealed multiple insanitary conditions, including (i) inadequate cleaning practices; (ii) ineffective pest control measures; (iii) failure to properly maintain equipment, utensils and the sprout production environment; (iv) a building structure not constructed to allow for adequate floor and wall cleaning and maintenance; and (v) employee practices that allowed for potential contamination, including employees wearing boots and aprons that were not changed, cleaned or sanitized before reentering the production area.
FDA notified Wholesome Soy of its findings, the complaint says, and the owner allegedly told the agency that the company ceased production in August 2014 and retained a food safety consulting firm and an industrial cleaning and sanitizing chemical supplier. Wholesome Soy then resumed production less than a month later without adequately addressing its sanitation issues, the government argues, and FDA met with the owner in November 2014 to ensure that Wholesome Soy stopped production until it did so. “The facility is not currently producing or distributing food, but nothing prohibits Defendants from resuming production without adequate corrective actions,” the complaint states. “Based on the foregoing, Plaintiff is informed and believes that, unless restrained by order of the Court, Defendants will violate [the FDCA] again.”