FDA WARNING_LETTER - Hiroshi's Enterprises, Inc. - April 29, 2008

On April 29, 2008, the FDA inspected a seafood processing facility at 736 Northeast Martin Luther King Blvd., Portland, Oregon, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render scombroid species products, such as Yellowfin tuna, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate Critical Limit:** The HACCP plan for scombroid species lists a critical limit of "No more than 4 hrs. Cumulative time for thawing and butchering" at the "Finished Product Storage" critical control point (CCP), which is insufficient to control scombrotoxin formation. It lacks a specific maximum storage temperature or reference to ice adequacy (21 CFR 123.6(c)(3)). 2. **Insufficient Monitoring Procedures:** The HACCP plan for scombroid species at the "Receiving Fish" CCP lists a critical limit of "Temperature: Max. 40 degrees F," but the monitoring procedures do not include taking product temperatures or any other temperatures (21 CFR 123.6(c)(4)).