FDA WARNING_LETTER - National Federation Of Fisheries Co-Operatives

The FDA issued a Warning Letter to National Federation of Fisheries Co-Operatives in Seoul, South Korea, following a review of their HACCP plan for anchovy products, submitted in October 2010 after a "Dried Anchovies" entry was detained. The FDA determined the firm is in serious violation of the Federal Food, Drug, and Cosmetic Act, rendering their anchovy products adulterated under 21 USC 342(a)(4) due to insanitary conditions.

Key violations of the Seafood HACCP Regulation (21 CFR Part 123) include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The plan fails to list scombrotoxin (histamine) formation as a reasonably likely food safety hazard for anchovies, which are scombroid species. The firm is responsible for controlling time/temperature abuse from harvest vessels through processing and storage. Additionally, the plan references (b)(4) and ready-to-eat products without specifying controls. No drying process is referenced, despite "dried anchovy" products, which poses risks for histamine and pathogens. Lack of evisceration for larger fish (5 inches or more) before drying/processing poses a Clostridium botulinum risk. Packaging in oxygen-impermeable materials (e.g., vacuum packaging) also creates a C. botulinum hazard