The U.S. Food and Drug Administration announced today that the Portland Shellfish Co., Inc.; Jeffrey D. Holden, company president; Satyavan Singh, quality manager; and John A. Maloney, general manager, have signed a consent decree prohibiting them from distributing seafood in interstate commerce until the FDA has approved in writing the company’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program.
The seafood processor, based in Portland, Maine, sells ready-to-eat lobster, shrimp and crab products to retailers in Massachusetts, California, Georgia, Illinois, Nevada, Washington, New Jersey and Louisiana.
The consent decree, entered by Judge John A. Woodcock in the U.S. District Court for the District of Maine, on Jan. 20, 2011, stems from evidence that Portland Shellfish violated the Federal Food, Drug and Cosmetic Act by introducing into interstate commerce food that was prepared, packed or held under insanitary conditions.
FDA investigators documented significant deviations from the seafood HACCP regulation, which the FDA enforces to ensure the safety of fish and fishery products distributed to the public. Failure to comply with the seafood HACCP regulation renders food adulterated under the Act.
The FDA’s laboratory analysis of samples collected by investigators during the company’s 2010 inspection confirmed the presence of L. mono within a Portland Shellfish food processing facility and in ready-to-eat product. The company has issued four recalls in the past two years due to L. mono contamination and potential contamination of its ready-to-eat products.
L. mono is a pathogenic bacterium that, when ingested, can cause the disease listeriosis. L. mono infections can affect all age groups but are most severe in the elderly, infants, pregnant women and those people whose immune systems are impaired by medications or illness. The most serious forms of listeriosis can result in meningitis and septicemia and the disease can be fatal for individuals at high-risk. Listeriosis in pregnant women can result in miscarriage or septicemia in the newborn.
Previous FDA inspections documented insanitary conditions at Portland Shellfish’s facilities and ongoing violations of applicable regulations. Despite the FDA’s warnings and the company’s promises to correct the violations, the most recent FDA inspection, conducted between April 2010 and June 2010, revealed that Portland Shellfish Co., Inc., continued to violate FDA regulations and the Act.
“The continued violation of seafood HACCP and the presence of L. mono in a food processing facility is a particularly significant public health risk,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Today’s action shows that the FDA will take enforcement action necessary to make sure that those companies that must have preventative controls in place to ensure the safety of their products adhere to all applicable requirements.”
The decree also allows the FDA to order a shutdown, recall or other corrective action in the event of future violations and requires Portland Shellfish to pay the costs of inspections performed pursuant to the decree. Failure to abide by the agreement also can lead to civil or criminal penalties.