FDA WARNING_LETTER - Hayai Zushi - July 15, 2011

On July 11-13, 15, 2011, the FDA inspected Hayai Zushi's seafood processing facility at 307 West 600 South, Salt Lake City, Utah. The inspection revealed violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110).

The FDA determined that the firm's ready-to-eat seafood spring rolls and ready-to-eat squid salads are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Significant violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for ready-to-eat seafood spring rolls to control pathogen growth (specifically *Clostridium botulinum*) and major food allergens at the labeling step, violating 21 CFR 123.6(a) and (b). 2. **Failure to Maintain Sanitation Control Records:** The firm did not maintain sanitation monitoring records for water safety, prevention of cross-contamination, handwashing/toilet facilities, protection of food/packaging/contact surfaces, proper labeling/storage/use of toxic chemicals,