New Day Fisheries Inc – FDA Warning Letter, Jun 8, 2012

On August 2, 2012, the FDA issued a Warning Letter to New Day Fisheries, Inc. following an inspection on June 7-8, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their whole, cooked Dungeness crab and pickled herring adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to monitor sanitation conditions (21 CFR 123.11(b)):** * Condensation, insect webbing, peeling paint, and rust observed dripping into processing areas. * Water splashing from the floor onto crab cages and ice shovels. * Employees handling raw crab then cooked crab without changing/cleaning gloves. * Presence of rat excreta and gaps in the dry storage warehouse. * Potable water hose stored on a wet floor without backflow prevention. 2. **Inadequate HACCP plan critical limits (21 CFR 123.6(c)(3)):** The pickled herring HACCP plan's critical limits for receiving (temperature and decomposition checks) were insufficient to control histamine formation, especially given extended transport