Taiyo Seafood NY Inc – FDA Warning Letter, May 29, 2014

The FDA inspected Taiyo Seafood NY, Inc. from May 19-29, 2014, finding serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their ready-to-eat tuna and frozen vacuum-packed tuna Ahi products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **HACCP Plan Deficiencies:** The HACCP plan for ready-to-eat tuna loins failed to list pathogenic bacteria as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 2. **Monitoring and Record Keeping Failures:** The firm did not follow monitoring procedures for refrigeration unit temperature assessments (twice daily) at the storage CCP for scombrotoxin control, and the electronic recording device was non-functional. Additionally, temperature records for ready-to-eat tuna loins during storage were not maintained (21 CFR 123.6(b) and (c)(7)). 3. **Sanitation Control Records:** The firm lacked sanitation monitoring records for food contact surface cleanliness and the efficacy value (ppm) of their sanitizer used for ready-to-eat tuna loins (2