FDA WARNING_LETTER - True Taste, LLC. - November 06, 2012

On October 30, November 1, and 6, 2012, the FDA inspected True Taste, LLC's seafood processing facility in Kenosha, Wisconsin, 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 (CGMP) regulation for foods (21 CFR Part 110). These violations render the firm's cold and hot smoked fish products, including various vacuum-packed mackerel, whitefish, rainbow trout, and lake trout, 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.

Key violations include: 1. **Failure to take corrective action:** The firm did not take corrective action when the process for Cold Smoked Mackerel deviated from the critical limit for (b)(4) to control *Clostridium botulinum* toxin formation, and the affected batch was shipped without evaluation. 2. **Inadequate record keeping:** The firm failed to record monitoring observations for brining and smoking steps, including time, temperature, salt content, and (b)(4) testing, as required by their HACCP plans. 3. **Lack of HACCP plan:** No HACCP plan was in place for Cold Smoked Whitefish to control