FDA WARNING_LETTER - Roy's Fishery - October 25, 2012

On March 5, 2013, the FDA issued a Warning Letter to Roy's Fishery, Naalehu, HI, following an inspection from October 22-25, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their seafood products, including frozen ready-to-eat scombroid finfish, smoked tuna, smoked marlin, and dried mackerel scad (opelu), 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)):** HACCP plans for "Smoked Marlin & Ahi" and "Dried Opelu" failed to list *Clostridium botulinum* growth and toxin formation, and undeclared allergens (finfish, soy, wheat) as reasonably likely food safety hazards. The "Smoked Marlin" label incorrectly stated "Keep refrigerated" instead of "Keep frozen," requiring additional barriers for *C. botulinum* control. 2. **Missing Critical Control Point (21 CFR 123.6(a) and (c)(2)):** The "Smoked Marlin & Ahi" HACCP plan did not list thawing as