The U.S. Food and Drug Administration’s (FDA’s) last 2015 warning letter for a food manufacturer went out Dec. 22nd to a seafood processor in the Bronx. FDA WarningThe company, Uoya Inc, was warned about “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. Uoya’s  “Big Eye Tuna Loins,” vacuum-packed farmed raw Yellowtail Fillets, and Fresh Mackerel were said to be adulterated for insanitary conditions that might cause them to be rendered injurious to health.FDA says the regulations require Uoya Inc. to conduct a hazard analysis for each fish or fish product for food safety hazards that are likely to occur.  The warning letter said:  “However, your firm does not have a HACCP plan for:

  • Packaged raw farmed yellowtail fillets packaged with Time Temperature Indicators (TTIs) to control the hazards of scombrotoxin (histamine) formation, Clostridium botulinum toxin formation, and pathogenic bacteria growth and toxin formation;
  • Fresh mackerel to control the hazards of scombrotoxin (histamine) formation, parasites, and pathogenic bacteria growth and toxin formation, for product intended for raw consumption; and
  • Fresh striped jack to control the hazard of scombrotoxin (histamine) formation, parasites, and pathogenic bacteria growth and toxin formation for product intended for raw consumption.”

FDA also outlines in detail the corrective actions that must be included in its HACCP plan. FDA’s New York District issued the warning letter and gave the seafood processor 15 days to respond.