FDA WARNING_LETTER - Pescaderia La Marinera del 23 SA de CV - September 23, 2011

On January 24, 2012, the FDA issued a Warning Letter to Pescaderia La Marinera del 23 SA de CV following an inspection on September 22 and 23, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation identified was the firm's failure to have a written HACCP plan for yellowtail and other scombrotoxin (histamine) forming fish species to control the food safety hazard of scombrotoxin formation, as required by 21 CFR 123.6(a) and (b). As a primary processor receiving fish directly from harvest vessels, the firm is responsible for implementing receiving controls and adequate operational controls to prevent or reduce scombrotoxin development.

The FDA stated that these violations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), meaning they were prepared, packed, or held under conditions that may render them injurious to health.

The firm is required to respond in writing within thirty working days, outlining specific corrective actions, including a copy of any new HACCP plans, at least five product days of monitoring records, and verification records