FDA WARNING_LETTER - Keum Han Industrial Co. - February 18, 2020

On February 17-18, 2020, the FDA inspected Kyung Eun Kim's seafood processing facility in Gangwon-do, South Korea, finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat (RTE) dried squid products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1))**: The revised HACCP plan for butter-flavored and bulgogi-flavored dried squid products (dated February 28, 2020) failed to list undeclared allergens (dairy and soy) as a reasonably likely food safety hazard. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2))**: HACCP plans for RTE dried squid products (seasoned, butter-flavored, and bulgogi-flavored) lacked critical control points for unrefrigerated processing, where products are exposed for approximately (b)(4) hours. The FDA recommends processing at 40°F (4.4°C) or below, or limiting unrefrigerated steps to 2 hours when temperatures exceed 7