Vegi-Pak Farm grows, processes, packages and distributes ready-to-eat soybean sprouts and holds and distributes tofu and mung bean spouts. The products are sold to markets in Maryland, Virginia and Washington, D.C.
The consent decree, entered in the U.S. District Court for the District of Maryland, on March 4, 2011, stems from evidence that Vegi-Pak Farm violated the Federal Food, Drug and Cosmetic Act by introducing into interstate commerce food that was prepared, packed or held under insanitary conditions, and by adulterating food after shipment in interstate commerce.
The decree prohibits the defendants from processing, holding and distributing bean sprouts until they demonstrate to the FDA that their facility and processing equipment are sanitary and in compliance with the requirements of the Act and its implementing regulations. The defendants must, among other requirements, retain an independent sanitation expert to develop a sanitation plan and destroy all in-process and finished food articles in the facility. The FDA may require the sprout grower to recall products, cease production, or take other corrective actions if the agency discovers future violations.
Violations found during FDA's September 2010 inspection of the facility included the presence of numerous flies, inadequate removal of waste, inadequate conveyance of liquid waste; inadequate screening against pests; inadequate cleaning and sanitizing of processing equipment; inadequate hand washing facilities and poor employee sanitation practices. Inspections conducted by the Maryland Department of Health and Mental Hygiene in August 2010 and in April and July 2008, also found similar insanitary conditions at Vegi-Pak Farm.
The production of bean sprouts without adequate sanitation practices in place poses a significant public health risk because of the pathogens such as Listeria monocytogenes, Salmonella and Escherichia coli.
"This enforcement action shows that FDA will take strong enforcement action against companies that fail to meet federal food safety regulations to protect their customers from foodborne illness," said Associate Commissioner for Regulatory Affairs Dara A. Corrigan. "We have stopped Vegi-Pak operations until they demonstrate to the FDA that its facility and processing equipment are suitable to prevent contamination."
Source: Food and Drug Administration