FDA WARNING_LETTER - Kanetoku Corporation - November 09, 2012

On November 8-9, 2012, the FDA inspected Kanetoku Corporation's Sasayama Factory in Japan, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The inspection resulted in an FDA-483, and despite the firm's December 12, 2012, response with corrective actions and a revised HACCP plan, concerns remain.

The FDA determined that the firm's frozen, ready-to-eat capelin roe (masago) is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was prepared, packed, or held under conditions that may render it injurious to health.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The revised HACCP plan for capelin roe does not list *Clostridium botulinum* as a reasonably likely food safety hazard, despite the product being packed in 5kg plastic bags, which can create an anaerobic environment. The FDA recommends including handling instructions like "Keep Frozen" and "Thaw under Refrigeration Immediately Prior to Use" on labels and monitoring label inclusion as a critical control point. 2. **Missing Critical Control Points (21 CFR 123.