Procesadora Marina De La Costa Oriental Del Lago C.A. Warning Letter Details

Summary

Procesadora Marina De La Costa Oriental Del Lago C.A., a Venezuelan seafood processor, received a warning for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during a remote inspection in May 2024. The company's ready-to-eat cooked crab meat products (jumbo lump, lump, cocktail claw, claw, and blue crab) were deemed adulterated because the facility failed to establish and implement a compliant HACCP plan with documented critical limits as required under 21 CFR Part 123. The FDA had not received a response to items of concern discussed at the conclusion of the assessment.