FDA WARNING_LETTER - Seamus LLC - November 05, 2014

The FDA issued a Warning Letter to Seamus LLC following an inspection from October 29 to November 5, 2014, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and food labeling regulations (21 CFR 101).

The facility's frozen vacuum-packaged cooked ready-to-eat eel kabayaki products were deemed adulterated due to unsanitary conditions and lack of a HACCP plan to control hazards like pathogen growth (including *Listeria monocytogenes* and *Clostridium botulinum* toxin formation) and undeclared allergens. Specifically, the HACCP plan needed controls for sufficient cooking, labeling instructions for thawing vacuum-packaged products under refrigeration, and visual checks for accurate allergen declarations (eel, soy, sulfites).

Additionally, three 100% Natural Fresh Water Eel products (Fillet, Kabayaki, Hot and Spicy) were misbranded. Violations included: 1. Failure to declare major food allergens (wheat from soy sauce, eel) as required by Section 403(w) of the Act. 2. Unauthorized and improperly formatted nutrient content claims, such as "high in Omega 3" and "higher amounts of protein and lower levels of fat," violating 21 CFR 101.54 and 101.62. 3.