FDA WARNING_LETTER - Sunrise Meats Inc - December 04, 2013

An FDA inspection of a seafood processing facility in Port Angeles, Washington, from December 3-4, 2013, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering hot-smoked and cold-smoked fishery products adulterated. Additionally, frozen, vacuum-packaged, hot-smoked, and cold-smoked fishery products were found to be misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act.

Key HACCP deficiencies included the failure of HACCP plans for hot-smoked fish and cold-smoked salmon to list allergens, inadequate monitoring and record-keeping at critical control points (Brining, Smoking/Cooking, Cooler Storage), and a lack of alternative controls for Clostridium botulinum in vacuum-packed seafood. The firm also failed to verify critical limits, lacked a HACCP plan for smoked oyster products, and did not maintain sanitation monitoring records. Furthermore, the firm failed to keep written records of corrective actions for cooler temperature deviations.

Misbranding violations involved labels failing to declare major food allergens (fish species), not bearing the common or usual name of the food, omitting ingredients from brine pre-mixtures, and lacking the name and place of business of the manufacturer/distributor. Labels also failed to declare units of measure for weight. The FDA requires prompt corrective action, a written response within 15 working days with supporting documentation, and warns of potential legal action, including seizure or injunction, and reinspection fees.