FDA WARNING_LETTER - Bluefin Seafoods Corporation - December 05, 2014

On January 13, 2015, the FDA issued a Warning Letter to Bluefin Seafoods Corporation following an inspection from December 1-5, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). As a result, the firm's fish and fishery products, including finfish and crustacean shellfish, are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to have a HACCP plan for crustacean shellfish to control the hazard of undeclared major food allergens, as required by 21 CFR 123.6(a) and (b). The submitted "Allergen HACCP Plan 2014" only addressed finfish. 2. The "Histamine HACCP Plan 2014" listed an inadequate critical limit at the (b)(4) critical control point for histamine formation, specifically regarding the quantity of (b)(4), which does not align with FDA recommendations for temperature control (40°F or below) or complete ice surrounding the product. This violates 21 CFR 123.6(c)(3). 3.