FDA WARNING_LETTER - Evershing International Trading Inc. - December 20, 2010

On February 28, 2011, the FDA issued a Warning Letter to Evershing International Trading Inc. following an inspection from December 15-20, 2010, at their San Jose, California, seafood importer establishment. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The FDA found that Evershing International Trading Inc. failed to have product specifications addressing the histamine hazard for imported fish sauce from Thailand, violating 21 CFR 123.12(a)(2)(i). Additionally, the firm did not implement an affirmative step to ensure imported Fish Sauce and Frozen Salted Fish were processed according to FDA's seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii). Although the firm's affirmative step was maintaining a copy of the foreign processor's HACCP plan (21 CFR 123.12(a)(2)(ii)(D)), they lacked an English copy of a written guarantee from the foreign processor confirming compliance with FDA seafood HACCP regulations.

These violations render the fish sauce and frozen salted fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act