FDA 483 - Northwest Frozen LLC - March 03, 2025

Northwest Frozen LLC, a frozen sushi manufacturer in Des Moines, WA, received a Form 483 with three observations. The firm failed to properly implement HACCP monitoring and verification procedures, including temperature controls and thermometer calibration. Additionally, their HACCP plan did not adequately identify all food safety hazards, such as Clostridium botulinum growth in reduced oxygen packaging. Finally, sanitation control records were found to be inaccurate, failing to reflect observed issues with handwashing, cross-contamination, and unclean food-contact surfaces and equipment.