Gold Coast Trading Co. – FDA Warning Letter, May 12, 2010

On May 7-12, 2010, the FDA inspected Gold Coast Trading Co., a seafood processor and importer, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The firm's smoked fish was 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 "Mudfish, Smoked Mackeral, Akwaabi, Broche, Smoked Tilapia" had critical limits at receiving and cooler storage that were insufficient to control *Clostridium botulinum* or histamine formation. 2. **Missing HACCP Plan for Smoked Herring:** Smoked herring, an imported product, was not listed on the firm's HACCP Plan Form. 3. **Failure to Conduct Hazard Analysis for Uneviscerated Fish:** The firm did not perform a hazard analysis for smoked uneviscerated fish to control *Clostridium botulinum*. FDA considers uneviscerated fish (over 5 inches) that are salt-cured, dried, or smoked to be adulterated, regardless of storage conditions. 4. **Insufficient Record Review Frequency:** A monthly record review was deemed insufficient; FDA recommends review within one week of monitoring