FDA WARNING_LETTER - Blue Marine Seafoods Trading - November 09, 2012

The FDA issued a Warning Letter to Blue Marine Seafoods Trading on November 9, 2012, following a review of their submitted HACCP plans, monitoring records, and product flow diagrams for tuna products. The FDA determined the firm has serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Inadequate HACCP Plan (21 CFR 123.6(c)(2)):** The plan for frozen tuna products lacks critical control points (CCPs) for histamine formation and pathogen growth, specifically for processing, pre-chilling, and other specific processes (b)(4) and (b)(4) that pose Clostridium botulinum and histamine hazards. - **Missing Critical Limits (21 CFR 123.6(c)(3)):** The Receiving CCP lacks adequate critical limits for histamine formation, including sensory evaluation for decomposition and controls for transit to the facility from the wharf. - **Insufficient Monitoring Procedures and Frequencies (21 CFR 123.6(c)(4)):** Monitoring at the Receiving CCP is inadequate as it doesn't specify monitoring at the wharf. The (b)(4) CCP monitoring is insufficient for temperature control between checks. Harvest