The U.S. Food and Drug Administration announced Monday that Vegi-Pak Farm of Mt. Airy, MD, and its president, Sun Ja Lee, and general manager, Brian W. Lee, signed a consent decree earlier this month prohibiting them from processing, holding and distributing bean sprouts due to numerous sanitation problems.
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.
“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 in a news release. “We have stopped Vegi-Pak operations until they demonstrate to the FDA that its facility and processing equipment are suitable to prevent contamination.”
Vegi-Pak had ceased operations earlier when U.S. Attorney Rod Rosenstein filed a complaint seeking a permanent injunction. The company’s products are no longer on the market.
The consent decree, entered in the U.S. District Court for the District of Maryland on March 4, 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. The defendants must, among other requirements, retain an independent sanitation expert to develop a sanitation plan and destroy all in-process and finished food in its facility.
The FDA said it may require the sprout grower to recall products, cease production, or take other corrective actions if the agency discovers future violations.
During an inspection in September, FDA said if found numerous violations, including uncleaned equipment, fly infestation, 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 found similar sanitation problems, FDA said.
The production of bean sprouts without adequate sanitationposes a significant public health risk because of the pathogens such as Listeria monocytogenes, Salmonella and Escherichia coli. Contaminated raw or lightly cooked bean sprouts have been suspected or confirmed in at least 32 outbreaks of foodborne illness since 1996,