FDA WARNING_LETTER - SUSHI DEN JAPAN - February 07, 2014

On February 6-7, 2014, the FDA inspected Sushi Den Japan, a seafood processing facility, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm did not respond to the FDA 483 issued at the inspection's conclusion.

The FDA determined that the firm's Bonita, Yellowtail, Spanish Mackerel, and Jack Mackerel are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under conditions that may render them injurious to health.

Significant deviations include: 1. **Lack of HACCP Plan:** The firm does not have a HACCP plan for fresh raw Bonita, Yellowtail, Spanish Mackerel, and Jack Mackerel intended for raw consumption (sushi) to control food safety hazards like pathogen growth, scombrotoxin (histamine), and parasites (for Spanish and Jack Mackerel). This violates 21 CFR 123.6(a) and (c)(2). 2. **Inadequate Sanitation Monitoring:** The firm failed to monitor sanitation conditions and practices with sufficient frequency, violating 21 CFR 123.11(b) and 21 CFR Part 110. Evidence included: * Dried food particles and rust on