FDA WARNING_LETTER - Mariscos Perla Mar S. de R.L. - January 26, 2024

The FDA conducted a Foreign Regulatory Assessment (FRRA) of Mariscos Perla Mar S. de R.L. in Honduras from January 22-26, 2024, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). An FDA-483 was issued, and the firm's subsequent response, including revised HACCP plans for frozen raw lobster meat bags and frozen raw conch fillets, was deemed inadequate. The primary violations include the failure to conduct a proper hazard analysis to identify *Clostridium botulinum* growth and toxin formation as a food safety hazard during thawing in reduced oxygen packaging (ROP) at potentially unsafe temperatures, as required by 21 CFR 123.6(a) and (c)(1). Additionally, the firm failed to maintain adequate sanitation control records documenting monitoring and corrections for various conditions, including prevention of cross-contamination and control of employee health, as mandated by 21 CFR 123.11(c). These deficiencies render the firm's frozen raw lobster head meat and frozen raw conch fillets adulterated under 21 U.S.C. § 342(a)(4). Mariscos Perla Mar S. de R.L. must respond within fifteen working days with specific corrective actions, including revised HACCP plans and five consecutive days of monitoring records with English translations. Failure to adequately respond may result in refusal of admission of imported products, including detention without physical examination (DWPE) under Import Alert 16-120.