Rell & Renn Seafood Sphere, Inc. – FDA Warning Letter, Apr 21, 2012

On August 28, 2012, the FDA issued a Warning Letter to Rell & Renn Seafood Sphere, Inc. following an evaluation of their HACCP plan for tuna products, submitted via email on April 10 and 21, 2012. The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1))**: The HACCP plan for Fresh-Frozen Yellowfin Tuna failed to list critical food safety hazards such as *Clostridium botulinum* (due to vacuum packaging and reliance on freezing), pathogen growth (for products consumed raw), and undeclared allergens (fish being a major allergen). The FDA recommended including critical control points for label review to ensure "Keep Frozen" instructions and accurate species identification. 2. **Missing Critical Control Points (21 CFR 123.6(c)(2))**: The plan lacked critical control points for histamine formation. While the Product Flow Diagram and Hazard Analysis Worksheet referenced relevant steps, the HACCP plan only listed two generic critical control points. The FDA recommended listing processing steps (e.g