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Ocho Rios-Miami, Inc., a seafood warehousing and distribution facility in Miami, failed to comply with Seafood HACCP regulations required under 21 CFR Part 123, rendering their vacuum-packed split mackerel and other fish products adulterated. The company had not conducted a hazard analysis to identify food safety risks including parasites, scombrotoxin formation, pathogenic bacteria growth, and botulinum toxin formation associated with their products. The FDA documented these violations during inspections between March and July 2021 and issued two FDA Forms 483, but had not received corrective action notifications from the company as of the warning letter date. The facility's failure to implement a compliant HACCP plan and operate under sanitary conditions violated the Federal Food, Drug, and Cosmetic Act.