FDA WARNING_LETTER - New Zealand Seafood Marketing - April 17, 2015

The FDA inspected New Zealand Seafood Marketing's facility in Vernon, CA, from April 14-17, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their fish and fishery products, including tuna, swordfish, mahi mahi, rudder, wahoo, and smoked salmon, adulterated. Despite the firm's submission of updated HACCP plans on May 1, May 12, and June 2, 2015, the products remain adulterated. Key violations include inadequate critical limits and monitoring procedures in the 'Fresh-High Risk Finfish' HACCP plan for scombrotoxin control (21 CFR 123.6(c)(3) and (c)(4)), and similar deficiencies in the 'Smoke Salmon-High Risk' HACCP plan for C. botulinum toxin control. Additionally, corrective actions in both plans were deemed inappropriate (21 CFR 123.7(b)). The FDA requires a written response within fifteen working days outlining specific corrections with supporting documentation. Failure to promptly correct these violations may result in refusal of admission for imported products, detention, seizure, and/or injunction, emphasizing the firm's responsibility for compliance with HACCP and GMP regulations.