FDA WARNING_LETTER - Seven Seas Smoke House and Catering Services, Inc. - March 19, 2013

On May 1, 2013, the FDA issued a Warning Letter to Seven Seas Smoke House and Catering Services, Inc. following an inspection from February 25, 2013, to March 19, 2013. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The FDA determined that the firm's smoked vacuum-packed fishery products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **HACCP Plan Deficiencies:** The HACCP plans for ready-to-eat (RTE) cold and hot smoked vacuum-packed fish products (salmon, sturgeon, steelhead trout, mackerel, escolar, trout, paddlefish) failed to list critical food safety hazards such as histamines (in escolar and mackerel), parasites (in mackerel), and undeclared allergens. The plans also lacked adequate controls for pathogen growth/toxin formation and histamine formation due to cumulative time-temperature exposure during thawing, brining, drying, cold smoking, and packaging/labeling. For example, frozen mackerel was observed thawing overnight in an unrefrigerated room.