FDA WARNING_LETTER - Comercial Mares de Chiloe - July 10, 2019

On June 14, 2019, the FDA requested and reviewed the HACCP plan for salmon and trout products from Cardonal Bajo 2 7 Lote 1A, exported to the U.S. The review revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering the products adulterated under 21 U.S.C. § 342(a)(4).

The primary violation is the failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards in the HACCP plan, as required by 21 CFR 123.6(a) and (c)(1). Specifically, the plan did not address pathogen growth and toxin formation (including *Clostridium botulinum* in vacuum-packaged frozen products) and parasites. The FDA recommends controls for pathogens in ready-to-eat salmon, appropriate labeling for vacuum-packaged products to prevent *C. botulinum* growth (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use"), and controls for parasites in ready-to-eat refrigerated salmon.

The firm must respond in writing within fifteen working days, outlining specific corrective actions, including a revised HACCP plan and five consecutive days of completed monitoring records. Failure to respond adequately may result in refusal of admission of products under Section 801(a)