FDA WARNING_LETTER - Hickory Smokehouse of Las Vegas, Inc. - May 23, 2014

On November 14, 2014, the FDA issued a Warning Letter to Hickory Smokehouse of Las Vegas, Inc., following an inspection from May 8-23, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated and frozen, vacuum-packaged, ready-to-eat hot and cold smoked fish products adulterated.

Key violations include: 1. **Inadequate HACCP Plans:** * For "Cold Smoked Salmon," the critical limit at the Smoking CCP (curing room temperature) was insufficient to control pathogen growth and toxin formation, as actual smoke or liquid smoke was not applied. The firm's use of a (b)(4) process lacked scientific support for equivalent inhibitory effects. * The critical limit at the Vacuum Packaging/Labeling CCP for "Cold Smoked Salmon" was inadequate to control *Clostridium botulinum* toxin formation, lacking a "Keep Frozen" label warning. * For "Hot Smoked Trout," the critical limit at the Vacuum Packaging/Labeling CCP was inadequate for *Clostridium botulinum* control, despite a "Keep refrigerated under 38F" label. 2. **Inappropriate Corrective Actions:** The corrective action plan for "Cold Smoked Salmon" at various CCPs was not appropriate and