FDA WARNING_LETTER - Fulton Seafood Inc - June 17, 2008

On September 24, 2008, the FDA issued a Warning Letter to Fulton Seafood Inc. following an inspection from June 13-17, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for imported fish and fishery products.

Specifically, Fulton Seafood Inc. failed to implement written verification procedures as required by 21 CFR 123.12(a)(2). The firm's use of a foreign manufacturer's HACCP plan was deemed inadequate. The manufacturer's HACCP plan for Canned Sardines in Tomato Sauce lacked information on controlling histamine formation during raw material storage and did not include a written guarantee from the foreign processor.

Furthermore, an FDA sample collected on April 15, 2008, from Canned Sardines in Tomato Sauce imported by Fulton Seafood Inc. was found to be violative for histamines (131.0 ppm, 248.5 ppm, 124.7 ppm in three subsamples), leading to detention and refusal of admission. This indicated the foreign firm's HACCP plan was inadequate for histamine control.

The FDA stated that the Canned Sardines in Tomato Sauce product was adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Failure to