FDA WARNING_LETTER - L.A. Lucky Import & Export - June 14, 2012

On August 16, 2012, the FDA issued a Warning Letter to L.A. Lucky Import & Export Inc. following an inspection from June 7-14, 2012, at their Bell, CA facility. 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 the firm failed to implement an affirmative step for imported fishery products, as required by 21 CFR 123.12(a)(2)(ii). For example, no affirmative step documentation was provided for white anchovy, yellow stripe trevally, spiny eel, and cooked snail meat from a specific manufacturer. Additionally, the firm lacked product specifications for imported fishery products, violating 21 CFR 123.12(a)(2)(i), with no safety specifications available for the aforementioned products.

These violations render the white anchovy, yellow stripe trevally, spiny eel, and cooked snail meat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

L.A