COFISA - Conservas de Peixe da Figueira, S.A. Warning Letter Details

Summary

COFISA - Conservas de Peixe da Figueira, S.A., a Portuguese seafood processing facility, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA inspection in April 2024. The company failed to establish and implement adequate HACCP plans complying with 21 CFR Part 123 requirements, rendering their canned tuna and canned sardine products adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's corrective action responses submitted between May and July 2024—including revised undated HACCP plans and monitoring records—were inadequate to address the compliance failures.