FDA WARNING_LETTER - Artesian Trout Farm - July 07, 2010

The FDA inspected Artesian Trout Farm on June 24, 30, and July 7, 2010, finding serious violations of seafood HACCP (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110) regulations. The firm's air-packed hot-smoked trout and salmon were deemed adulterated due to insanitary conditions, potentially rendering them injurious to health. Additionally, smoked trout and salmon products were misbranded under sections 403(e)(1), (i)(2), and (w)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **HACCP Plan Deficiencies:** The HACCP plan for smoked trout and salmon lacked a critical limit for temperature during brining to control *Staphylococcus aureus* growth and toxin formation. 2. **Missing Critical Control Point:** The HACCP plan failed to list cooling as a critical control point for pathogen growth. Monitoring of time and temperature during cooling was also absent, with smoked fish observed at 79.7°F after 4.5 hours post-smoking. 3. **Inadequate Monitoring Procedures:** The HACCP plan did not specify monitoring procedures and frequency for the storage critical control point to control pathogen growth. 4. **Misbranding - Allergen Declaration:** Smoked trout labels failed to declare "fish" as a major food allergen as