FDA WARNING_LETTER - Seaview Fisheries Inc. dba Seaview Lobster Co. - August 01, 2014

The FDA inspected Seaview Fisheries, Inc. dba Seaview Lobster Co. on July 22, 23, and August 1, 2014, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their seafood products, including ready-to-eat cooked lobster meat, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for crabmeat listed an insufficient cooking critical limit of "(b)(4)" without a supporting cooking study for the firm's lobster sizes (up to (b)(4) each), which are significantly larger than those used in the cited study ((b)(4) each). 2. **Missing Critical Control Points:** The HACCP plan for cooked lobster meat failed to identify critical control points for cooling and/or picking to control pathogenic bacteria growth and toxin formation, despite employees handling cooked lobster meat within (b)(4) after cooking. 3. **Insufficient Sanitation Monitoring:** The firm did not adequately monitor sanitation conditions as required by 21 CFR 123.11(b) and 21 CFR Part 110. Specific observations included the lack of an air gap or backflow prevention device on