FDA WARNING_LETTER - Pesquera Alvarez y Alvarez Ltda - May 10, 2013

The FDA conducted an inspection of Pesquera Alvarez y Alvarez Ltd. in Chile on May 9-10, 2013, revealing serious violations of seafood HACCP (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110) regulations. The firm's frozen, vacuum-packed cooked king crabmeat products are deemed adulterated under Section 402(a)(4) of the FD&C Act due to insanitary conditions.

The firm's HACCP plan for frozen, vacuum-packaged cooked king crab meat is deficient. It fails to list critical control points for pathogen contamination and growth, specifically regarding cooling immediately after cooking (recommending cooling from 57.2°C to 21.1°C within 2 hours, then to 4.4°C within an additional 4 hours) and processing steps after cooling that involve significant handling time (recommending ambient temperatures at or below 4.4°C and monitoring every 2 hours). Additionally, the plan does not include a critical control point for the post-processing holding period, where the product is held before freezing, recommending refrigeration at 4.4°C or less with continuous temperature monitoring.

Furthermore, the HACCP plan does not list Clostridium botulinum germination, growth, and toxin formation as a reasonably likely food safety hazard for frozen, vacuum-packaged molded crabmeat. The FDA recommends