FDA WARNING_LETTER - Sevrin Tranvag AS - September 03, 2014

On September 2 and 3, 2014, the FDA inspected Sevrin Tranvag AS, a seafood processing facility in Fiskarstrand, Norway, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's mackerel products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violation is the firm's failure to have a written HACCP plan for frozen whole round mackerel to control food safety hazards, specifically histamine formation and Clostridium botulinum growth and toxin formation, as required by 21 CFR 123.6(b). Although processing times are short, the firm lacks a critical control point for receiving fish to ensure safe handling aboard harvest vessels. Additionally, there is no critical control point to ensure packaging includes safe handling instructions (e.g., "Keep Frozen, Thaw Under Refrigeration Immediately Prior to Use") to prevent Clostridium botulinum growth.

The FDA acknowledged the firm's September 19, 2014, response, which included corrective action pictures and a risk analysis, but noted the absence of a HACCP plan. Sevrin Tranvag AS must respond in writing within fifteen working days, outlining specific corrective steps, including a revised HACCP plan copy and five consecutive days of monitoring records to demonstrate implementation. Failure