FDA WARNING_LETTER - blue star shrimp company ( - January 16, 2008

On January 15-16, 2008, the FDA inspected Blue Star Shrimp Company dba Blue Star Seafood Inc. and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, their Pasteurized Crab Meat, Scombroid-Toxin Forming Species, Tuna, Mahi Mahi, and Cooked Crab Products are deemed adulterated.

Key violations include: 1. **Inadequate Critical Limits:** The HACCP plan for "Pasteurized Crab Meat" lacked adequate critical limits at "Receiving" and "Storage" to control *Clostridium botulinum* toxin formation, failing to ensure appropriate product temperatures (recommended at or below 40°F). 2. **Insufficient Monitoring Procedures:** HACCP plans for "Cooked Crab Products" and "Pasteurized Crab Meat" had inadequate monitoring procedures at "Receiving" and "Storage" for pathogen growth and *Clostridium botulinum* control. Recommendations included requiring transporter records, monitoring ice adequacy, or using continuous temperature monitoring devices. 3. **Failure to Implement Record Keeping:** The firm did not record monitoring observations for temperature checks and ice presence at "Receiving" and "Storage" for "Pasteurized Crab Meat" and "Scombroid-Toxin Forming Species, Tuna, Mahi Mahi SPP" as