The firm was found to have carried out repeated violations of federal regulations including 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.
The state’s District Court imposed a consent decree on the company and three leading officers; company president Stanley S. Pearlman, vice president Jonathan D. Pearlman and HACCP coordinator Stephen G. Bardsley. The ruling also bans former president Thomas Spencer from any involvement with the company.
Under the decree, Congressional Seafood must have its HACCP and sanitation plans submitted by an independent expert and approved by FDA. The judgment allows FDA to shut down the firm, recall its products, or take other corrective action in the event of future violations. The defendants have also been ordered to pay the costs of inspections performed by FDA officials in the build up to the decree’s imposition. The company could face civil or criminal penalties if it flouts the ruling.
“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.