FDA WARNING_LETTER - Dockside Fish Market - May 05, 2011

The FDA inspected Dockside Fish Market in Grand Marais, Minnesota, from May 3-5, 2011, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice regulations (21 CFR 110). These failures render the firm's smoked fish products adulterated under the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the HACCP plan for smoked fish failing to list histamine and undeclared allergen hazards, lacking adequate time and temperature critical limits for brining, and listing inadequate critical limits for the brining process. Monitoring procedures and frequencies for smoking and cooling critical control points were deemed insufficient, and the firm failed to implement its own listed cooling procedures for smoked fish. Additionally, the corrective action plan for brining, smoking, and cooling was inappropriate, and the HACCP plan for smoked fish omitted finished product storage as a critical control point. Crucially, the firm lacked a HACCP plan entirely for fresh and frozen raw herring, whitefish, and lake trout to control histamine and undeclared allergens. Dockside Fish Market must respond in writing within 15 working days, detailing specific corrective actions and providing supporting documentation. Failure to promptly correct these violations could lead to further FDA enforcement, including product seizure and injunctions preventing the firm from operating. The firm is responsible for ensuring full compliance with all applicable regulations.