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Grupo VPAS C.A., a Venezuelan seafood processor, was cited for serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) during a Foreign Remote Regulatory Assessment conducted January 22-26, 2024. The company's HACCP plan for fresh-frozen, IQF Medregal fillet products failed to comply with regulatory requirements, rendering the products adulterated under the Federal Food, Drug and Cosmetic Act. The FDA requested an English translation of the company's February 2024 response documentation on April 22, 2024, but received no response and proceeded with evaluation using automated translation tools.