FDA WARNING_LETTER - High Tide Seafoods, Inc. - July 25, 2008

On July 24-25, 2008, an FDA inspection of a food and seafood processing facility at 808 Marine Drive, Port Angeles, Washington, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). These violations render the firm's canned Dungeness crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm lacks a HACCP plan for cooked Dungeness crabmeat in five-pound sealed metal cans to control hazards like *Clostridium botulinum* growth and toxin formation, natural toxins, environmental chemical contaminants, and pesticides (21 CFR 123.6(a) and (b)). 2. **Incomplete Hazard Analysis:** The HACCP plan for Dungeness crab does not list environmental chemical contaminants and pesticides as reasonably likely food safety hazards, despite the crab being harvested from areas where pollutants are present (21 CFR 123.6(c)(1)). 3. **Inadequate Monitoring Procedures:** The HACCP plan's monitoring procedures/frequencies at the "Store (fresh)" critical control point for Dungeness crab are insufficient to control