FDA WARNING_LETTER - Blackstar Fish Co Inc - February 28, 2013

On February 26 and 28, 2013, the FDA inspected a seafood processing facility at 700 Dover Road, Grand Rivers, KY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's paddlefish roe adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for paddlefish roe does not list *Clostridium botulinum* as a food safety hazard, despite the product being packed in plastic buckets with press-on lids, which can create an anaerobic environment. The firm also failed to analyze finished caviar for water phase salt levels. Additionally, HACCP plans for paddlefish caviar and paddlefish catfish do not list allergens as a food safety hazard. 2. **Missing Critical Limits:** The paddlefish roe HACCP plan lacks critical limits at the receiving critical control point to control pathogen growth, toxin formation, and *Clostridium botulinum* toxin formation, specifically regarding transit time, temperature abuse, and adequate icing. 3. **Insufficient Monitoring Procedures:** The HACCP plan for paddlefish roe has inadequate monitoring procedures for chilling and storage. The