Taiyo Seafood, Inc – FDA Warning Letter, Aug 29, 2013

On October 25, 2013, the FDA issued a Warning Letter to Taiyo Seafood Inc. following an inspection from August 13-29, 2013, at their Columbia, MD facility. The inspection revealed serious deviations from seafood Hazard Analysis and Critical Control Points (HACCP) Regulations (21 CFR Part 123), rendering their fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plans for Tuna (histamine) or Salmon (pathogen growth). 2. **Inadequate Corrective Actions:** Failure to take corrective action for Clostridium botulinum hazard in Pasteurized Crabmeat, found stored at unsafe temperatures (52.8°F cooler, 48.3°F internal product). 3. **Failure to Implement Monitoring/Recordkeeping:** No records for received crabmeat, no temperature checks or chart recorder for ready-to-eat tuna cooler, and thermometer calibration not conducted for extended periods. 4. **Inadequate HACCP Plan Verification:** Verification procedures for Pasteurized Crabmeat and Histamine-prone fish were insufficient, lacking review of monitoring/complaint records and proper thermometer calibration. 5. **Deficient HACCP Plan Monitoring Procedures:** HACCP plans listed inadequate monitoring procedures and