Taiyo Seafood Boston Inc. – FDA Warning Letter, May 23, 2012

On June 21, 2012, the FDA issued a Warning Letter to Taiyo Seafood Boston Inc. following an inspection from May 10-23, 2012. The inspection revealed 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), rendering the firm's fish and fishery products adulterated.

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to develop HACCP plans for products like raw, refrigerated Spanish mackerel and vacuum-packaged yellowtail, which are necessary to control hazards such as scombrotoxin, parasites, *Clostridium botulinum* toxin, and pathogenic bacteria. 2. **Failure to Take Corrective Actions:** The firm did not implement corrective actions when deviations occurred, specifically regarding tuna receiving without ice, despite the HACCP plan requiring rejection of such product. Records showed multiple instances of tuna received without ice since April 2, 2012, with no documented corrective actions. 3. **Inadequate Record Keeping:** The firm failed to maintain complete records for monitoring observations at critical control points for raw refrigerated tuna, specifically regarding the number of containers examined and ice adequacy. 4. **Insufficient Monitoring Frequency:** The firm did not follow the specified monitoring frequency for verifying ice adequacy and cooler