Comercial Mares de Chiloe under the spotlight for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a warning letter, the US Food and Drug Administration (FDA) informed Director Rodrigo Becerra that Commercial Mares de Chiloe’s HACCP plan, entitled “Quality Assurance Manual Based on HACCP” for their salmon and trout products, which are intended to be consumed raw or cooked, shipped refrigerated or frozen, and maybe vacuum packaged, demonstrates serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
Salmon and trout products
Accordingly, the firm’s salmon and trout products are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health, it wrote.
Pathogen growth is reasonably likely to occur in fish and fishery products that are exposed to unrefrigerated temperatures (e.g. temperatures above 4.4°C (40°F) for unsafe periods of time. FDA inspectors suggested that the firm’s HACCP plan include appropriate controls to ensure that each product is appropriately labeled with handling instructions (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”), so it is not conducive to C. botulinum growth and toxin formation. Additionally, the FDA recommended that the firm’s HACCP plan include controls for parasites in their ready-to-eat refrigerated salmon products.
Listeria Monocytogenes
Additionally, FDA noted that on July 10, 2019, the FDA placed Commercial Mares de Chiloe on the red list of Import Alert 16-39 “Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes” based on evidence which identified Listeria Monocytogenes in analyzed portions frozen raw salmon intended for raw consumption.
Violations
“Your response should outline the specific things you are doing to correct these violations, ” the FDA warned. “More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation,” it warned.
