Product Liability

FDA files suit against Wholesome Soy after listeria outbreak kills two

Wholesome Soy Products logo 231x210 FDA files suit against Wholesome Soy after listeria outbreak kills twoWholesome Soy Products Inc. is now being sued by the U.S. government following a listeria outbreak traced to the company’s soybean and mung bean sprouts.

According to the FDA, five people from Michigan and Illinois were hospitalized from June through August due to listeriosis – a sickness caused by the ingestion of Listeria monocytogenes. Despite receiving treatment, two of five infected individuals died as a result of the sickness.

The FDA’s investigation found the listeria strains to be “highly related” to the strains discovered at Wholesome Soy’s facilities, which were cited for multiple health violations during its prior inspections.

“FDA has repeatedly warned defendants about serious, violative conditions and conduct at the facility,” the lawsuit claims.

Problems found during inspections in August, September and October were also not properly addressed by Wholesome Soy, the FDA said. Some of the issues included poor maintenance, inadequate cleaning and even troubles with pest control. Bean sprout production was halted in late August by Julia Trinh, Wholesome Soy president and owner; however, government officials claim the cessation was temporary and ineffective.

“Defendants resumed production even though they: (1) did not take adequate steps to prevent the presence and risk of L. mono contamination; (2) did not demonstrate that they had adequately addressed each violation observed by FDA; and (3) did not verify that their employees had been adequately trained on sustainable sanitation practices and procedures,” the complaint states.

Once the FDA alerted Trinh to the positive testing of Listeria monocytogenes, or L. mono, in the samples taken by agency, Wholesome Soy agreed to shut down in November following a regulatory meeting. Although the company remains closed, concerns still loom whether Trinh will attempt to resume production after a hiatus.

“The facility is not currently producing or distributing food, but nothing prohibits defendants from resuming production without adequate corrective actions,” the complaint claims. “Based on the foregoing, plaintiff is informed and believes that, unless restrained by order of the court, defendants will violate 21 U.S.C. § 331(k) again.”

The case is listed as United States of America v. Wholesome Soy Products Inc. et al., case number 1:15-cv-02974, filed in the U.S. District Court for the Northern District of Illinois.

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