Mariscos Procesados - CAMPRESA - S.A. – FDA Warning Letter, Aug 16, 2024

On November 5, 2024, the FDA issued a Warning Letter to Mr. Yen Yi Chen, following a Foreign Remote Regulatory Assessment (FRRA) of their seafood processing facility in Rivas, Nicaragua, from August 12-16, 2024. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The FDA found the firm's responses from August 23 and September 30, 2024, including a revised HACCP plan for frozen whole fish and fillet (histamine), to be inadequate. Consequently, their frozen mahi-mahi fillets in vacuum-packaging are deemed adulterated under 21 U.S.C. § 342(a)(4) as they were prepared, packed, or held under conditions that may render them injurious to health.

Specific violations include: 1. Failure to conduct a proper hazard analysis and include a critical control point (CCP) for storage in their HACCP plan to control scombrotoxin (histamine) formation in fish stored in ice bins before processing and freezing (21 CFR 123.6(a) and (c)(2)). 2. Failure to list critical limits in their HACCP plan (21 CFR 123.6(c)(3)) at: a.