FDA WARNING_LETTER - Koike Seafood, Inc. - July 10, 2008

On July 9-10, 2008, the FDA inspected a firm located at 500 South River Street and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). The firm's Scombroid-forming seafood was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was prepared, packed, or held under insanitary conditions.

Significant violations included: 1. Failure to implement monitoring procedures as identified in the HACCP plan for tuna, mahi-mahi, and marlin ono (HACCP Plan Form-Group 2). Specifically, the firm did not continuously monitor cooler temperatures with a temperature logger at the storage critical control point, despite the plan requiring it with a daily visual check. An investigator observed no continuous temperature logger installed. 2. The corrective action plan for tuna, mahi-mahi, and marlin ono at the receiving critical control point was inappropriate. Re-icing or bringing the temperature below 40°F after temperature abuse does not prevent adulterated product from entering commerce, failing to comply with 21 CFR 123.7(b).

The FDA warned of potential further actions, including product seizure and/or injunctions.