A consent decree of permanent injunction was entered against Henry’s Farm, Inc. in Woodford, Virginia, and its owner Soo C. Park last week, after the US Food and Drug Administration (FDA) found failings over a number of years.
Under the consent decree, defendants cannot process or distribute food until they bring operations into compliance with the federal Food, Drug and Cosmetic Act (FDCA) and tell FDA, including cleaning and sanitizing the facility and equipment.
Inspection findings
FDA repeatedly warned the firm that further action could be taken if unsanitary conditions persisted.
Melinda Plaisier FDA’s associate commissioner for regulatory affairs, said: “When a company continues to produce food that presents a risk for consumers, the FDA will take whatever steps necessary to protect public health.”
Henry’s Farm manufactured and distributed soybean sprouts and repackaged and distributed mungbean sprouts. No illnesses were reported from the products.
FDA inspected Henry’s Farm’s manufacturing facility in Woodford in 2014 and found unsanitary conditions, including: sprout debris at various places along the packaging line and floor; three dead insects and a live spider on packing material in the processing room and three dead insects in the seed storage area.
The agency inspected Henry’s Farm’s three times before the December 2014 inspection - in June 2014, December 2013 and May 2012.
In each inspection, investigators found inadequate sanitation practices including: standing water in sprout production areas; failure to maintain cleaning logs; rodent activity in the sprout production area and failure to use any antimicrobial treatment to reduce the hazard of pathogens that may be present on seed for sprouting.
Listeria found
FDA investigators discovered L. monocytognes at the plant, including samples taken from food contact surfaces and a sample of finished sprout product collected in May 2012.
During this inspection JJBS soybean sprouts and mung-bean sprouts were found to be misbranded because the label did not have the name and place of business of the manufacturer, packer, or distributor.
Henry’s Farm, Inc. must retain an independent laboratory to collect and analyze samples for L. mono, retain an independent sanitation expert and develop a program to control the pathogen and eliminate unsanitary conditions at its facility.
Once the company is permitted to resume operations, the FDA may require it to take action if the agency discovers future food safety violations.
“Insanitary conditions at food processing facilities can pose well-known risks to consumers, but such risks can be effectively mitigated if companies handling food take proper precautions,” said Benjamin Mizer, principal deputy assistant attorney general, head of the Justice Department’s Civil Division.