FDA WARNING_LETTER - Grant's Smokehouse Ltd. - January 15, 2013

On January 14-15, 2013, the FDA inspected Grant's Smokehouse Ltd. in Maryport, UK, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's hot and cold-smoked salmon products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Structure:** The HACCP plan combined cold-smoked and hot-smoked salmon, despite having distinct processes, critical control points (CCPs), and critical limits, violating 21 CFR 123.6(b)(2). Separate plans are required for each product. 2. **Missing Critical Control Points:** * Hot-smoked salmon plan lacked a CCP for refrigerated finished product storage to control pathogen growth (e.g., *Clostridium botulinum*). * Cold-smoked salmon plan lacked CCPs for raw fish receipt (to control pathogen growth without a heat kill step) and for holding raw material and in-process salmon prior to cold-smoking. 3. **Inadequate Critical Limits:** * Hot-smoked salmon's "Hot Smoke/Cook" CCP critical limits were insufficient to control *Clostridium botulinum* toxin formation; FDA recommends