FDA WARNING_LETTER - Land Ice and Fish Limited - September 10, 2007

On September 4-10, 2007, an FDA inspection of Nu-Wave Seafood Consultants, LLC, a U.S. importer, revealed they were importing fish and fishery products from Land Ice and Fish Limited. The FDA collected Land Ice and Fish Limited's HACCP plan for Yellow Fin Tuna, Big Eye Tuna, Albacore Tuna, Mahi Mahi, and Wahoo.

The FDA found serious deviations from the seafood HACCP regulation (21 CFR Part 123). Specifically, the HACCP plan failed to include critical control points for: 1. **Receiving fish directly from harvest vessels:** To control histamine development, the plan lacked procedures like obtaining harvest vessel records or conducting histamine testing. A sampling plan for decomposition (minimum 118 fish per lot or entire lot) was also suggested. 2. **Storage of fish prior to distribution:** The plan did not describe procedures for proper packing to ensure temperature control, which is critical for preventing histamine development, especially during extended holding times.

These omissions render the firm's products adulterated under Section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (21 USC § 342(a)(4)), meaning they were prepared, packed, or held under insanitary conditions.

Land Ice and Fish Limited must respond in writing within fifteen working days, outlining specific corrective actions, including revised HACCP plans and verification