FDA WARNING_LETTER - Race Street Foods, Inc - September 10, 2010

On November 9, 2010, the FDA issued a Warning Letter to Race Street Foods, Inc. following an inspection of their seafood processing facility and warehouse in San Jose, CA, on September 7, 8, and 10, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fresh, refrigerated seafood products, including unpasteurized Dungeness crabmeat in cans, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for reduced oxygen packaged seafood products, specifically refrigerated, unpasteurized, canned Dungeness crabmeat. This omission fails to control the food safety hazard of pathogen growth and toxin formation, including *Clostridium botulinum*, which is reasonably likely in reduced oxygen environments, especially if products are not continuously maintained at or below 38°F. This violates 21 CFR 123.6(a) and (b). 2. **Inappropriate Corrective Actions:** The firm's HACCP plans included inappropriate corrective actions, violating 21 CFR 123.7(b). * For "Fish fillets" at