Fujino Enterprises, Inc. – FDA Warning Letter, Aug 3, 2010

On July 28, 29, and August 3, 2010, the FDA inspected a seafood processing facility at 205 Yale Avenue, Princeton-By-The Sea, California, 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). The facility's refrigerated, vacuum-packaged, ready-to-eat hot and cold smoked salmon products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plans:** The HACCP plans for "HOT SMOKED SALMON" and "COLD SMOKED SALMON" listed critical limits for brining that were insufficient to control pathogen growth and toxin formation, specifically lacking a critical limit for brining temperature (21 CFR 123.6(c)(3)). 2. **Insufficient Monitoring Procedures:** Monitoring frequencies for refrigerator storage and smoking critical control points were inadequate to control pathogen growth and *Clostridium botulinum* toxin formation (21 CFR 123.6(c)(4)). Recommendations included continuous monitoring with daily visual checks for refrigeration and continuous monitoring with per-batch