FDA WARNING_LETTER - Eden F&C co., Ltd - April 26, 2024

The FDA issued a Warning Letter to Mr. Jinmin Kim of a seafood processing facility in Boeun, Chungcheongbuk, Korea, following an inspection on April 26, 2024. The inspection focused on ready-to-eat (RTE) seafood-containing corn dog products. The FDA identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering the products adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for frozen fish sausage corn dogs lacked a critical control point (CCP) at the receiving step for cooked vacuum-packed fish sausages to control non-proteolytic *Clostridium botulinum* (C. botulinum) growth. The firm's proposed criterion of receiving via refrigerated trucks was deemed inadequate. The FDA recommends a critical limit ensuring the refrigeration unit's ambient temperature is maintained below 3.3°C (38°F) with continuous monitoring. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan's critical limit for the "Storage process" CCP (CCP 4