FDA WARNING_LETTER - Custom Seafood Services Inc. - February 16, 2012

The FDA conducted an inspection of Custom Seafood Services Inc. in Seattle, Washington, on February 13, 14, and 16, 2012, revealing 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). Consequently, the firm's Dungeness crab sections and King crab legs and claws are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to adequately monitor sanitation conditions, specifically regarding condensation, dust, and other adulterants dripping onto products and equipment, as required by 21 CFR 123.11(b) and Part 110. The firm also failed to implement appropriate corrective actions when critical limits for cooking King and Dungeness crab were violated, contrary to 21 CFR 123.7(a). Additionally, monitoring procedures and frequencies listed in HACCP plans for crab products were not followed, as required by 21 CFR 123.6(b) and (c)(4). Finally, the firm's HACCP plans for all crab products failed to list allergens as a reasonably likely food safety hazard, violating 21 CFR 123.6(a) and (c)(1). The firm's responses to the FDA 483 were deemed partially adequate, lacking specific preventative measures and comprehensive corrective actions. The FDA requires a written response within fifteen working days, detailing specific corrections, including supporting documentation, and updated HACCP plans. Failure to comply may result in product seizure, injunction, and re-inspection fees.