FDA WARNING_LETTER - Burren Smokehouse Ltd. - March 08, 2019

On March 7 and 8, 2019, the FDA inspected Burren Smokehouse Ltd. in Lisdoonvarna, Ireland, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's refrigerated, vacuum-packaged hot and cold smoked fish products (salmon, trout, mackerel) are deemed adulterated under 21 U.S.C. § 342(a)(4) because they were prepared, packed, or held under conditions that may render them injurious to health.

The FDA acknowledged the firm's responses to the FDA-483, including revised HACCP plans, flow charts, and an SOP, but deemed them inadequate. Specific deficiencies include HACCP plans lacking specific procedures and frequencies for monitoring critical control points. The FDA also recommended updating critical limits for refrigerated storage and in-process handling to 4.4°C (40°F) or less, rather than 5°C. Furthermore, the firm's HACCP plans, with the exception of hot smoked farmed trout, do not adequately address the hazard of undeclared ingredients, specifically allergens, in finished products. The hot smoked farmed trout HACCP plan entirely omits the allergen hazard.

Burren Smokehouse Ltd. must respond in writing within fifteen working days, outlining specific corrective actions, including revised HACCP plans and five consecutive days of