FDA WARNING_LETTER - Sam Hak Food Corp - February 07, 2011

An FDA inspection of Sam Hak Food Corp.'s seafood processing facility in Bronx, NY, conducted from January 31 to February 7, 2011, 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 primary violation identified was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for refrigerated fish cakes, as required by 21 CFR 123.6(a) and (b). This plan is necessary to control reasonably likely food safety hazards, including pathogen growth (specifically Staphylococcus aureus and toxin formation), metal fragments, and undeclared allergens. Consequently, the firm's fish cakes are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The FDA mandates a written response within fifteen working days, detailing specific corrective actions, including submission of revised HACCP plans and monitoring records. Failure to promptly correct these deficiencies could lead to further regulatory actions, such as product seizure or injunctions preventing the firm from operating. The company is responsible for ensuring full compliance with all applicable regulations to prevent future violations.