The Congressional Seafood Company Inc. of Jessup, Md., and three of its executives were cited by FDA for failing to follow the agency’s Seafood Hazard Analysis and Critical Control Point (HACCP) regulations in the handling of products including raw, ready-to-eat tuna for sushi and sashimi, fresh and vacuum-packed crabmeat, frozen octopus and shrimp, and molluscan shellfish.
Violations included failure to document that fish were refrigerated at appropriate temperatures, failure to keep fish species separate to avoid cross-contamination, failure to meet sanitation standards or keep records of compliance, and failure to verify that imported fish met FDA standards.
“On numerous occasions, FDA has warned the defendants, both orally and in writing, about their conduct and has emphasized the importance of their compliance with the (Federal Food, Drug, and Cosmetic) Act,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA.
FDA today filed a consent decree of permanent injunction in the U.S. District Court for the District of Maryland. The decree, signed by U.S. District Judge Benson E. Legg, applies to the firm and company President Stanley S. Pearlman, Vice President Jonathan D. Pearlman and HACCP Coordinator Stephen G. Bardsley. The decree with Congressional Seafood also bars former company President Thomas P. Spencer from any involvement in management or operations of the firm.
Under the decree, to become compliant with food safety laws, Congressional Seafood must have its HACCP and sanitation plans submitted by an independent expert and approved by FDA.
The decree allows FDA to shut down Congressional Seafood, recall its products, or take other corrective action in the event of future violations. The decree requires the defendants to pay the costs of inspections performed pursuant to the decree. Failure to abide by the agreement can lead to civil or criminal penalties.
The FDA complaint accompanying the decree notes that the production of fresh, frozen and ready-to-eat seafood products without adequate HACCP plans poses a significant public health risk because these products are well-known sources Escherichia coli, Listeria monocytogenes, Clostridium botulinum, Salmonella spp., and other pathogenic microorganisms. Humans who consume food containing these bacteria can suffer serious health consequences.
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