FDA WARNING_LETTER - Stavis Seafoods, LLC - February 05, 2026

Stavis Seafoods, LLC, a seafood importer based in Boston, Massachusetts, was issued a Warning Letter by the FDA following an inspection conducted between February 3 and February 5, 2026, which followed a previous visit in June 2024. The inspection revealed serious violations of federal food safety regulations, specifically the Hazard Analysis and Critical Control Point (HACCP) requirements for imported fishery products. The primary violation involved the company’s failure to implement mandatory verification steps for its imported frozen aquaculture salmon fillets. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, importers are required to ensure that foreign suppliers process food under safety standards equivalent to those in the United States. Because Stavis Seafoods did not provide evidence of these affirmative verification steps, the FDA classified the salmon products as adulterated, noting they were prepared or held under conditions that could render them harmful to health. To address these findings, the company must provide a written response within 15 working days detailing its corrective actions. This response must include documentation such as updated importer verification records and evidence of implemented safety steps. Failure to rectify these issues may lead to further regulatory action, including the seizure of products, legal injunctions, or the refusal of future imports into the United States.