FDA WARNING_LETTER - Maldives Industrial Fisheries Company Limited - January 09, 2019

The FDA issued a Warning Letter to Felivaru Fisheries Complex following an inspection from January 7-9, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's submitted response and revised HACCP plan were deemed inadequate. Consequently, their cooked ready-to-eat tuna products are considered adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act. Key violations include the failure to conduct a proper hazard analysis and have a HACCP plan that lists critical control points for Staphylococcus aureus growth and scombrotoxin formation during various processing steps. The firm also failed to establish adequate critical limits for scombrotoxin formation and lacked appropriate monitoring procedures and frequencies for histamine analysis. Additionally, the corrective actions outlined in their HACCP plan were not appropriate, as they did not address the root cause of deviations. The FDA requires a written response within 15 working days, detailing specific corrective actions, including a revised HACCP plan and monitoring records. Failure to comply may result in refusal of admission for imported products through detention without physical examination (DWPE) and potential re-inspection fees. The letter also noted a comment regarding the firm's failure to address undeclared allergens (soy) as a reasonably likely hazard. The firm is responsible for ensuring full compliance with all applicable regulations.