FDA WARNING_LETTER - Dangjin Food Inc.

This Warning Letter from the FDA to Dangjin Food Inc. addresses serious deviations from seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) for their boiled, dried anchovies and dried Pollock. These products were detained upon entry into the U.S., prompting a review of the firm's HACCP plans.

The FDA found that the firm's HACCP plan for boiled, dried anchovies failed to list histamine and pathogen growth, including *Clostridium botulinum* growth and toxin formation, as reasonably likely food safety hazards. Anchovies are susceptible to scombrotoxin (histamine) development from time and temperature abuse, and uneviscerated anchovies pose a *Clostridium botulinum* risk. Additionally, as shelf-stable products, they must achieve a water-phase salt level of at least 10% or a water activity below 0.85 to control pathogen growth, which was not addressed. The use of unlined cardboard containers for shipping was also noted as insufficient to prevent rehydration.

For dried Pollock, the HACCP plan did not list pathogen growth as a food safety hazard, despite the firm's own hazard analysis referencing pathogen survival and cross-contamination. *Staphylococcus aureus* toxin formation was cited as a potential hazard due to time and temperature abuse. Similar to anchovies, as a shelf-stable product, dried Pollock must achieve a water activity of 0