FDA WARNING_LETTER - Ocho Rios-Miami, Inc. - July 09, 2021

The FDA inspected a seafood warehousing and distribution facility in Miami, FL, on March 29-May 06, 2021, and June 29-July 09, 2021. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering the seafood products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. Failure to conduct a hazard analysis for products like Vacuum-packed Split Mackerel (hazards: Parasites, Scombrotoxin, Pathogenic Bacteria Growth, C. botulinum) and Salted Cod/Pollack (hazards: Parasites, Pathogenic Bacteria Growth). 2. Absence of written HACCP plans for refrigerated Vacuum-packed Split Mackerel, Salted Pollack, and Salted Cod to mitigate identified hazards at receiving, storage, and distribution. 3. HACCP plan for Refrigerated Salted Herring and Mackerel did not list Pathogenic Bacteria Growth and Toxin Formation due to Time and Temperature Abuse as a reasonably likely hazard at Receiving and Storage. Additionally, the walk-in cooler's continuous time-temperature recording device was not functioning. 4. Failure to implement written verification procedures and an affirmative step for imported fishery products (e