FDA WARNING_LETTER - GRAND BK CORP. - August 15, 2011

On August 4-15, 2011, the FDA inspected Grand BK Corp.'s seafood processing and importer establishment, identifying serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. Consequently, their salted fish products, including pacific saury, croaker, and butterfish, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for salted vacuum-packed fish lists a water phase salt critical limit (≥ (b)(4)%) at the brining control point insufficient to control *Clostridium botulinum*, and product labeling lacks thawing instructions. 2. **Missing Hazard Analysis:** The HACCP plan for Salted Fish (including salted pacific saury) fails to list scombrotoxin formation as a reasonably likely food safety hazard. 3. **Failure to Take Corrective Actions:** The firm did not take corrective actions when water phase salt levels for salted croaker, butterfish, and pacific saury fell below the critical limit, or when salted pacific saury lacked required labeling. 4. **Inadequate Record Keeping:** The firm failed to record monitoring observations at the packaging/labeling critical control point for pathogen growth in Salted Fish.