FDA WARNING_LETTER - Fog River, LLC - December 22, 2011

On December 19-22, 2011, the FDA inspected Fog River, LLC's seafood processing facility in Salt Lake City, Utah, 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). These violations render the firm's frozen and fresh seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to conduct a hazard analysis and implement a written HACCP plan for canned crabmeat, vacuum-packaged smoked salmon, and raw amberjack (Kampachi) to control pathogen growth (21 CFR 123.6(a) and (b)). The firm's January 10, 2012, response was inadequate as it lacked a HACCP plan for raw amberjack. 2. The HACCP plan for scombroid finfish listed an inadequate critical limit ("product must be received with adequate cooling media") at the receiving critical control point to control histamine (21 CFR 123.6(c)(3)). The firm's response appears to address this. 3. Failure to implement the monitoring procedure of "Continuous, with visual check of recorded data twice per day" at the refrigerated storage critical