FDA WARNING_LETTER - Villa Tatra, Inc. - August 30, 2011

The FDA inspected Villa Tatra, Inc.'s seafood processing facility from August 22-30, 2011, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their cold and hot smoked fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for cold smoked salmon failed to list *Staphylococcus aureus* as a reasonably likely food safety hazard at the brining step. 2. **Missing Critical Control Points (CCPs):** The cold smoked salmon HACCP plan did not list receiving and raw ingredient storage as CCPs for pathogen growth, nor freezing as a CCP for parasite control. 3. **Inadequate Critical Limits:** The hot smoked salmon HACCP plan's critical limit at the smoker baking CCP was insufficient to control *Clostridium botulinum* growth, lacking the required 145°F for 30 minutes internal temperature and monitoring. 4. **Failure to Implement Monitoring Procedures:** The firm did not follow its HACCP plan's monitoring procedure for cold smoked salmon, failing to observe and document that the smoker temperature did not exceed 90°F to control *Clostridium botulinum*. 5. **Failure to Take Correct