FDA WARNING_LETTER - Chaur Fong Inc. dba 888 Food Company - August 19, 2009

On November 30, 2009, the FDA issued a Warning Letter to Chaur Fong, Inc., dba 888 Food Company, following an inspection from August 12-19, 2009. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The FDA determined that the company's seafood products, including ready-to-eat fish "balls," "cakes," "loafs," HA GAO Shrimp Dumplings, and frozen Featherback Fish Paste, are adulterated because they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for "fully cooked, not shelf stable fish products" listed critical limits for cooking that were insufficient to control *Clostridium botulinum*. The stated internal product temperature was not adequate to achieve a 6D log reduction for *C. botulinum*, requiring a validated scientific study or reference to demonstrate adequacy. 2. **Missing HACCP Plan:** The firm lacked a HACCP plan for HA GAO shrimp dumplings to control the food safety hazard of sulfites. 3. **Insufficient Sanitation Monitoring:** The company failed to sufficiently monitor sanitation conditions and practices, specifically