FDA WARNING_LETTER - smoked seafood, inc. - December 19, 2016

On June 27, 2017, the FDA issued a Warning Letter to Smoked Seafood, Inc. d/b/a Little Mermaid Smokehouse following an inspection from November 29 to December 19, 2016. The inspection revealed that several products, including Salmon/Kapitan, Seafood Croissant, Smoked Salmon Trout, Smoked Gorbusha, and Balik/Kapitan, were misbranded under Section 403 of the Act [21 U.S.C. § 343] and 21 CFR Part 101.

Key violations include: 1. **Failure to declare major food allergens by specific species names (Section 403(w)):** Products containing "fish" did not properly declare the specific species (e.g., "Gorbusha" for steelhead/rainbow trout, "Kapitan" for escolar, "Balik" for sturgeon, and "Salmon" without specific species). The "Seafood Croissant" also contained "crab imitation" with undeclared allergenic sub-ingredients. 2. **Failure to declare appropriate common or usual names (Section 403(i)(1)):** Product names like "Kapitan," "Balik," "Gorbusha," and "Salmon Trout" were not acceptable common or usual names for the respective fish species. The "Seafood Croissant" lacked an appropriate descriptive