YAMAHARU COMPANY – FDA Warning Letter, Apr 2, 2014

The FDA inspected Yamaharu Company's seafood processing facility in Tokyo, Japan, on April 1-2, 2014, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's mackerel products, specifically scombrotoxin (histamine) forming fish, were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations included: 1. **Inadequate Critical Limits:** The HACCP plan for fresh seafood lacked adequate critical limits at the packing critical control point to control scombrotoxin formation. Specifically, it did not include a corresponding critical limit for time when fish are exposed to temperatures between (b)(4), with FDA recommending fish not be exposed to ambient temperatures above 40°F (4.4°C) for more than 4 cumulative hours. 2. **Inadequate Monitoring Procedures:** Monitoring procedures at the packing critical control point were insufficient to control histamine formation. Monitoring the packing room temperature and packing time only at the start and close of operations was deemed inadequate to ensure consistent adherence to critical limits. FDA recommends monitoring the length of time each scombrotoxin-forming fish is exposed to unrefrigerated conditions (above 40°F). 3. **Inadequate Corrective Actions:** The corrective action plan for fresh seafood was insufficient