COFISA - Conservas de Peixe da Figueira, S.A. – FDA Warning Letter, Apr 12, 2024

On December 18, 2024, the FDA issued a Warning Letter to COFISA - Conservas de Peixe da Figueira, S.A., following an inspection on April 10 and 12, 2024. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their canned tuna and sardine products adulterated.

The firm's responses, submitted in May and July 2024, including revised HACCP plans, were deemed inadequate. Key violations for canned sardines included failure to list *Staphylococcus aureus* growth and toxin formation as a reasonably likely hazard during a specific processing step, and inadequate critical limits for histamine control (temperature criteria, decomposition allowance, and cumulative time limits). The corrective action plan for histamine in canned sardines was also deemed inappropriate due to the lack of target histamine limits.

For canned tuna, the corrective action plan for histamine was similarly inappropriate, lacking target histamine limits. Additionally, the firm failed to adequately monitor sanitation conditions, specifically not sanitizing food contact surfaces after washing and rinsing.

The FDA requires a written response within fifteen working days, outlining specific corrective actions, including revised HACCP plans, five consecutive days of completed monitoring records, and any additional information demonstrating full compliance. Failure to respond adequately may result in refusal of admission of imported products, including detention without physical examination (DWPE) under