FDA WARNING_LETTER - sam's marketing inc. - April 06, 2011

The FDA inspected Sam's Marketing Inc., dba CoCo's Fish Market, from March 24 to April 6, 2011, uncovering serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These deficiencies render their fresh, refrigerated seafood products, including tuna and yellowtail, adulterated. Key HACCP violations include the failure to conduct a proper hazard analysis for pathogen growth, inadequate critical limits for histamine control at receiving and finished product storage, non-implementation of recordkeeping systems, and inappropriate corrective action plans. Additionally, the firm failed to adequately monitor sanitation conditions, evidenced by issues with water safety, unclean and damaged food contact surfaces, cross-contamination risks, filthy handwashing facilities, and pest exclusion. Further GMP violations included unsanitary plant maintenance, unhygienic employee practices, unsuitable facility design, and improper waste disposal. The firm must respond within fifteen working days with specific corrective actions and supporting documentation to avoid potential product seizure or operational injunction.