Smoked Salmon Unlimited – FDA Warning Letter, Feb 14, 2020

The FDA inspected Fish Island's seafood processing facility in London, UK, on February 13-14, 2020, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's cold smoked salmon products are deemed adulterated due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for cold smoked salmon (dated September 22, 2011) failed to list pathogen growth and toxin formation as a food safety hazard at a critical control point (CCP). 2. **Failure to Implement Monitoring Procedures:** The firm did not monitor critical limits for *Clostridium botulinum* growth and toxin formation at two CCPs as specified in their HACCP plan. Finished product testing between September 26 and November 28, 2019, showed water phase salt levels below recommended levels on five occasions, with no corrective actions taken. 3. **Lack of Sanitation Control Records:** The firm failed to maintain records for monitoring the condition of food contact surfaces, prevention of cross-contamination, maintenance of handwashing facilities, protection of food from adulteration, proper labeling/storage of toxic compounds, and control of employee health. 4. **Inappropriate Corrective Actions:** Corrective actions in the HACCP plan for cold smoked salmon were inadequate at two CCPs