FDA WARNING_LETTER - Young Ocean, Inc - May 17, 2012

On October 19, 2012, the FDA issued a Warning Letter to Young Ocean, Inc. following an inspection of their Kent, Washington facility from April 24 to May 17, 2012. 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).

The FDA determined that Young Ocean, Inc.'s salted pollock roe, frozen pollock roe IQF, fresh imitation crabmeat with vacuum pack, and fresh fish (tuna, salmon, fluke, sea urchin roe) products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plans:** The firm lacked a HACCP plan for salted pollock roe and frozen pollock roe, IQF, to control pathogen growth. Submitted plans were inadequate, with critical limits like "Pick up thawed roe" not meeting the definition of a critical limit, and monitoring for "Freshness" being unquantifiable. 2. **Insufficient Monitoring Frequencies:** The HACCP plan for fresh imitation crab meat with vacuum pack had inadequate monitoring frequencies for temperature at "Storing