FDA WARNING_LETTER - Seorak Clean Food - September 10, 2013

The FDA inspected Seorak Clean Food in Sokcho, Republic of Korea, on September 9-10, 2013, identifying serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Despite a November 20, 2013 response from the firm, concerns persist. The firm's squid sausage product is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to HACCP deficiencies. Key violations include failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards (e.g., undeclared allergens, Clostridium botulinum, Bacillus cereus) in the HACCP plan (21 CFR 123.6(a) and (c)(1)). The HACCP plan also lacked critical control points for cooling to control pathogen growth (21 CFR 123.6(c)(2)) and adequate monitoring procedures and frequencies for critical control points (21 CFR 123.6(c)(4)). Additionally, the firm failed to monitor sanitation conditions and practices with sufficient frequency to comply with current good manufacturing practice requirements (21 CFR 123.11(b)). Furthermore, their cuttlefish sundae product is misbranded under Section 403(a)(1) of the Act, as it is labeled as squid but manufactured from cuttlefish. Seorak Clean Food must respond within 15 working days with specific corrective actions, including revised HACCP plans and five consecutive days of monitoring records, submitted in English. Failure to comply may result in refusal of admission of imported products, detention without physical examination, and re-inspection fees.