FDA WARNING_LETTER - Baits and Sea Foods, S.A. - May 11, 2023

On June 30, 2023, the FDA issued a Warning Letter to Ramiro J. Saborio for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) at their facility in Tipitapa, Nicaragua. These violations were identified during a Foreign Remote Regulatory Assessment conducted from May 8-11, 2023. The firm's fresh and frozen histamine-forming seafood products, including mahi-mahi, are deemed adulterated under 21 U.S.C. § 342(a)(4).

Specific violations include: 1. The HACCP plan for histamine-forming species (e.g., frozen, raw, vacuum-packaged mahi-mahi) does not list *Clostridium botulinum* growth and toxin formation, and undeclared allergens as reasonably likely food safety hazards (21 CFR 123.6(c)(1)). 2. The HACCP plan lacks critical control points (CCPs) for histamine formation during transit from local ports to the plant and during fish storage between layers of ice (21 CFR 123.6(c)(2)). 3. The HACCP plan's critical limit for sensory examination at receiving is inadequate to control histamine formation (21 CFR 123.6(c)(3)). 4.