FDA WARNING_LETTER - Ocean Beauty Seafoods, LLC - February 26, 2013

The FDA conducted an inspection of Ocean Beauty Seafoods, LLC in Monroe, Washington, from January 31 to February 26, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110).

The hot and cold smoked salmon products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Environmental sampling found eight sub-samples positive for *Listeria monocytogenes*, indistinguishable from previous findings in 2005 and 2011. One sub-sample matched *Listeria monocytogenes* found in a finished product lot (7425A2298B) in January 2012. The firm's "aggressive cleaning" corrective actions were deemed inadequate due to persistent *Listeria* detection.

The firm's March 15, 2013, response to the FDA 483 was partially adequate. Deficiencies included a lack of information on identifying non-stationary equipment for re-testing, unspecified construction details for a "(b)(4)" hallway (specifically, whether it would be self-contained), and uncompleted/unimplemented SSOP