FDA WARNING_LETTER - Great American Marketing Company - August 18, 2011

An FDA inspection of Great American Marketing Company's seafood processing facility in Houston, Texas, conducted from July to August 2011, revealed 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). Consequently, the firm's tuna salad sandwich products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations include the failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards, such as *Clostridium botulinum* growth and histamine formation, in the HACCP plan. The firm also failed to list all critical control points, like receiving, and had inadequate critical limits and monitoring procedures for critical control points. Additionally, the corrective action plan for refrigeration was deemed inappropriate, lacking provisions for product evaluation or root cause correction. Significant sanitation deficiencies were observed, indicating a failure to monitor sanitation conditions with sufficient frequency, including condensation dripping onto food contact surfaces, unclean equipment, soiled dishwater, and insanitary cleaning practices. The company must respond within fifteen working days, outlining specific corrective actions with supporting documentation, to prevent further regulatory action, including potential product seizure or injunction.