FDA WARNING_LETTER - Corporacion Del Mar - April 26, 2010

On August 3, 2010, the FDA issued a Warning Letter to Corporacion Del Mar following an April 22-26, 2010 inspection of their U.S. importer, Kingmar Seafood Corporation. The inspection revealed that Corporacion Del Mar was importing adulterated cooked crab meat due to serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The firm's HACCP plan for cooked crab meat failed to list two critical control points: 1. Refrigerated storage after packing but before pasteurization to control pathogen growth (e.g., *Clostridium botulinum*, *Staphylococcus aureus*). 2. A critical control point for the pasteurization process itself, specifically regarding the water used for cooling, to prevent pathogen introduction.

Additionally, the corrective actions in the HACCP plan were deemed inadequate. For instance, sampling for pathogens at the "Pasteurization" critical control point was insufficient, and corrective actions at other processing points (backing, picking, packing) did not address the root cause of deviations.

Corporacion Del Mar was required to respond in writing within fifteen working days, outlining specific corrections, including revised HACCP plans, five days of monitoring records, and verification records. Failure to respond adequately could lead to refusal of admission of their products into the U.S. under Section 801(a) of