FDA WARNING_LETTER - Nam Sun Fisheries Co. - March 25, 2014

On March 24-25, 2014, the FDA inspected Nam Sun Fisheries Co. in Yeosu-city, Korea, finding violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The FDA issued an FDA 483, Inspectional Observations. The firm's May 2, 2014, and July 17, 2014, responses, including a revised HACCP plan, were deemed inadequate.

The primary deviation is the firm's HACCP plan for salted mackerel fillets, specifically at the Processing critical control point, which lists inadequate monitoring procedures to control histamine formation and pathogen growth/toxin formation (e.g., *Staphylococcus aureus*). The plan's monitoring procedure of "(b)(4)" is insufficient. FDA recommends visual observations of unrefrigerated exposure time at the start and end of each processing step, or, if controlling exposure temperatures below 21.1 °C, monitoring time and ambient temperatures at least every two hours.

Failure to implement a compliant HACCP plan renders the firm's fish or fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). The firm must respond in writing within 15 working days, outlining specific corrective steps, including a revised HACCP plan and five consecutive days of completed monitoring records