FDA WARNING_LETTER - HKH JVC LLC. - August 24, 2012

On November 8, 2012, the FDA issued a Warning Letter to HKH JVC LLC following an inspection of their seafood processing facility in Honolulu, Hawaii, on August 21, 22, and 24, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The FDA determined that the firm's refrigerated, vacuum-packaged, ready-to-eat hot smoked tuna and refrigerated, histamine-forming fish (tuna, mahimahi, marlin) were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations identified from the firm's HACCP plans (dated 5-12-11 and 5-12-12) include: 1. **Inadequate Hazard Analysis:** The HACCP plan for "Hot Smoked fish, refrigerated" failed to list histamine formation in tuna as a reasonably likely food safety hazard during thawing and brining. (21 CFR 123.6(a) and (c)(1)) 2. **Missing Critical Control Points (CCPs):** HACCP plans for "Fish, fresh, processed (histamine-forming) vacuum packed 10K (