FDA WARNING_LETTER - Procesadora Marina De La Costa Oriental Del Lago C.A. - May 17, 2024

The FDA conducted a Remote Regulatory Assessment of Procesadora Marina De La Costa Oriental Del Lago C.A. from May 13-17, 2024, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat (RTE) cooked refrigerated and frozen crab meat products are deemed adulterated.

Key violations include: 1. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * The HACCP plan for refrigerated and frozen crabmeat in reduced oxygen packaging (ROP) has inadequate critical limits at the final product storage and label CCPs to control non-proteolytic *Clostridium botulinum* growth and toxin formation during distribution. The plan lacks requirements for labeling ROP frozen product with "keep frozen" and proper thawing instructions (e.g., thaw under refrigeration or remove from packaging before thawing). For refrigerated ROP product, the plan lacks a critical limit for attaching Time Temperature Indicators (TTIs) and additional CCPs for their use. * The critical limits for cooling cooked crab meat are inadequate, failing to include initial cooling under fans to (b)(4)°C within (b)(4) minutes before refrigeration.

2. **Inadequate Monitoring Procedures and Frequency (21 CFR 123.6(c)(