FDA WARNING_LETTER - Leong Kuba Sea Products, Inc - December 02, 2010

On February 16, 2011, the FDA issued a Warning Letter to Leong Kuba Sea Products, Inc. following an inspection from November 29 to December 02, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110).

The FDA determined that the firm's ready-to-eat (RTE) Ahi tuna, tuna sashimi, canned crabmeat, and other seafood products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for RTE raw salmon intended for sushi to control the food safety hazard of parasites (21 CFR 123.6(a), (b)). 2. **Inadequate Monitoring Procedures:** * The "Vacuum packed Smoked Salmon and Smoked Trout, and Pasteurized Crabmeat" HACCP plan had inadequate monitoring at receiving for *Clostridium botulinum* growth, as checking a limited number of boxes at receipt does not assure transportation conditions. Continuous temperature monitoring during transit was suggested. * The