Tyson Foods, Inc – FDA Warning Letter, Aug 21, 2009

An FDA inspection of Tyson Foods, Inc.'s seafood soup manufacturing facility in Fort Worth, TX, from August 19-21, 2009, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). The primary deficiency identified was that the firm's HACCP plan for "FDA Seafood Soups and Sauces" failed to list the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum toxin, which is reasonably likely to occur in products packaged in oxygen-impermeable films held under refrigeration. This renders the firm's seafood soups and sauces adulterated under 21 U.S.C. § 342(a)(4). Investigators observed shrimp and crab meat thawing at elevated temperatures (40-55°F) for extended periods. The firm's September 9, 2009, response, which included discarding product and implementing a new SOP, was deemed insufficient because SOPs cannot replace HACCP controls. The FDA requires the firm to revise its HACCP plan to include a critical control point for refrigerated storage/thawing, ensuring products are maintained at or below 40°F. A written response detailing corrective actions and supporting documentation is required within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.