Listeria Contamination and other Violations: Portland Shellfish Co Signs Consent Decree with FDA

• Date: January 26, 2011
• Source: Admin

The US Food & Drug Administration (FDA) announced on Jan 20, 2011 that the following have signed a consent decree:

• Portland Shellfish Co.
• Jeffrey D. Holden, company president
• Satyavan Singh, quality manager
• John A. Maloney, general manager

The consent decree prohibits them from distributing seafood in interstate commerce until the FDA has approved in writing Portland’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program.

The violation

The Portland, Maine-based seafood processor sells ready-to-eat lobster, shrimp and crab products to retailers in Massachusetts, California, Georgia, Illinois, Nevada, Washington, New Jersey and Louisiana. Portland Shellfish violated the Federal Food, Drug & 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. 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 a ready-to-eat product. L. mono is a pathogenic bacterium that, when ingested, can cause the disease listeriosis.

Previous FDA inspections documented insanitary conditions at Portland Shellfish’s facilities and ongoing violations of applicable regulations. Despite the FDA’s warnings Portland Shellfish Co., Inc. continued to violate FDA regulations and the Act. The decree also allows the FDA to order a shutdown, recall or other corrective action in the event of future violations. Failure to abide by the agreement can also lead to civil or criminal penalties.

Regulations

The FDA enforces the seafood HACCP regulation 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.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239108.htm