The consent decree of permanent injunction prevents the distribution of adulterated products and outlines what it must do if it wants to restart operations.
It prohibits the firm or owner Julia Trinh and manager Paul Trinh from receiving, processing, manufacturing, preparing, packing, holding and distributing mung bean and soybean sprouts unless corrective actions are made.
The defendants did not admit or deny the allegations in the complaint.
Link to Listeria outbreak
Listeria from the company’s mung bean sprouts was linked to five people who became ill from June through August 2014, all were hospitalised and two died.
In November last year, the company agreed to shut down, and the Illinois Department of Public Health oversaw destruction of remaining stock.
Under the permanent injunction, it cannot resume operations until they make several changes to the facility, undergo an FDA inspection and start a Listeria monitoring program, said the US Department of Justice (DOJ).
Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, said it is the agency’s responsibility to ensure appropriate action is taken when inspections and find results that could put consumers at risk.
“Agreeing to the consent decree is a first step in the right direction for this company.”
FDA inspections and findings
The move follows findings of contaminated food and environmental samples by the US Food and Drug Administration (FDA).
During a routine inspection, the FDA collected environmental and product samples that tested positive for Listeria monocytogenes (L. mono) in August 2014.
The Chicago-based firm agreed to recall and temporarily stop production of sprout products at the end of August.
The company reported it cleaned and sanitized the facility and hired an independent consultant to collect and test several samples that reportedly came back negative for L. mono.
They resumed operations in mid-September after making the corrections.
Later that month, there was an outbreak with a strain of L. mono linked to strains found in the samples previously collected by the FDA during its inspection.
The FDA began a follow-up inspection in October 2014 to verify the effectiveness of the company’s corrective actions.
Nine samples taken by inspectors tested positive for L. mono. Due to these findings, the agency concluded sprouts could not be safely manufactured in that environment.
According to the complaint, repeated deficiencies included employee practices that allowed for contamination of food contact surfaces and products; ineffective pest control measures; equipment, utensils and a sprout production environment not properly maintained.
“We must work to ensure that the food we buy from store shelves is safe and produced under sanitary conditions,” said Benjamin C. Mizer, principal deputy assistant attorney general of the Justice Department’s Civil Division.