FDA WARNING_LETTER - Two Rivers Smoked Fish LLC - February 05, 2015

On February 2, 3, and 5, 2015, the FDA inspected Two Rivers Smoked Fish, LLC's seafood processing facility in Hailey, Idaho, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their Smoked Steelhead, Smoked Trout, and Smoked Salmon products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions.

The firm's February 10, 2015, response to the FDA 483 was partially adequate, promising corrections but lacking sufficient evidence of implementation. Significant violations include: 1. Failure to fully document corrective actions for deviations from critical limits, specifically for smoked trout, batch 3641, at the Smoking/Cooking CCP (21 CFR 123.7(d)). 2. Failure to take appropriate corrective action when a critical limit deviation occurred for smoked trout, batch 3642, at the Smoking/Cooking CCP, where the internal temperature was insufficient (21 CFR 123.7(a)). 3. Failure to implement the record-keeping system listed in the HACCP plan, specifically not recording monitoring observations at the "Cooling after Smoking" CCP