FDA WARNING_LETTER - Yongdae Hwangtae Union Corp Daeryung - June 28, 2024

On January 16, 2025, the FDA issued a Warning Letter to Yongdae Hwangtae Union Corp Daeryung following a June 27-28, 2024, inspection of their seafood processing facility in Korea. The inspection revealed serious violations of the Seafood HACCP regulation (21 CFR 123), rendering their refrigerated and frozen desalted pollack products adulterated. The firm's July 30, 2024, response regarding environmental monitoring, equipment calibration, and employee training was deemed inadequate.

Key violations include: 1. **Inadequate Sanitation and Process Controls (21 CFR 117.80(a) and (b), 21 CFR 123.6(a) and (b)):** The firm's outdoor air-drying process for raw, ready-to-eat (RTE) dried pollack exposes the product to contamination from filth, including pathogens (e.g., animal waste, birds, insects). Controls are needed for all processing steps, both inside and outside the plant. 2. **Inadequate HACCP Plan Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan for "Dried Sliced Pollack" lacks adequate critical limits for pathogen growth and toxin formation, specifically *Clostridium botulinum*. For shelf-stable, reduced-oxygen packaged RTE dried