FDA WARNING_LETTER - Mason Brothers Co - July 08, 2009

The FDA inspected Mason Brothers Co.'s seafood processing facility in Wadena, Minnesota, on July 7-8, 2009, and found 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, their Herring in Wine Sauce was deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Inadequate HACCP plan monitoring procedures:** The HACCP plan for pickled herring listed an inadequate monitoring procedure at the receiving critical control point. Checking product surface temperature via infrared thermometer once upon receipt was insufficient to ensure ambient air temperature of 40°F or less during transit, as required by their critical limits. The firm's corrective action involving "reading the TTR" (time/temperature recorders) lacked sufficient detail for assessment. 2. **Failure to list identified hazards in HACCP plan:** The HACCP plan for pickled herring did not list histamine formation as a chemical food safety hazard, despite it being identified in their hazard analysis. While an email indicated this hazard was added, no documentation was provided.

The FDA warned that failure to promptly correct these violations could lead to further action, including product seizure and injunctions against the firm's operation. Mason Brothers Co. was