FDA WARNING_LETTER - Blue Marine Seafood Inc - October 29, 2013

On November 27, 2013, the FDA issued a Warning Letter to Blue Marine Seafood Inc. following an inspection from October 21-29, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). Consequently, the firm's fresh raw fish, including tuna, amberjack, mackerel, and salmon, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan:** The HACCP plan for fresh raw ready-to-eat (RTE) salmon did not list parasites as a food safety hazard, and the firm lacked supplier assurance for parasite control. The firm's response to perform a new hazard analysis and HACCP plan was deemed inadequate due to lack of submitted documentation and timely correction. 2. **Inadequate Critical Limits:** Critical limits for receiving and storage of fresh raw RTE salmon were insufficient to control pathogen growth (e.g., *Listeria monocytogenes*). The firm's response was again inadequate for the same reasons as above. 3. **Failure to Implement Monitoring Procedures:** The firm did not follow monitoring procedures for fresh raw RTE