U.S. Government Sues Wholesome Soy Products over Listeria Outbreak

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.”

Issue 561