Baits and Sea Foods, S.A. Warning Letter Details

Summary

Baits and Sea Foods, S.A., a seafood processing facility in Nicaragua, was found to have serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA remote assessment in May 2023, rendering their fresh and frozen histamine-forming products (including mahi-mahi) adulterated. The company's HACCP plan failed to identify critical food safety hazards required by regulation, specifically omitting Clostridium botulinum growth and toxin formation, and undeclared allergens as hazards for their frozen, vacuum-packaged wild-caught mahi-mahi products. The firm did not respond to discussion items raised by the FDA investigator at the conclusion of the assessment.