FDA WARNING_LETTER - Gordon Food Service, Inc. - November 12, 2010

On February 24, 2011, the FDA issued a Warning Letter to Gordon Food Service, Inc. following an inspection from October 29 to November 12, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated tuna salad and refrigerated raw shucked scallops adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:

1. **Inadequate Hazard Analysis and HACCP Plans:** * The HACCP plan for refrigerated tuna salad failed to list scombrotoxin (histamine) formation and pathogen growth/toxin formation as reasonably likely food safety hazards. The firm's analysis incorrectly concluded no hazards were identified, despite the reintroduction of pathogens and scombrotoxin-forming organisms after opening retorted tuna and the ready-to-eat nature of the product. * The HACCP plan for refrigerated raw shucked scallops in metal cans did not list *Clostridium botulinum* toxin formation as a reasonably likely hazard. The FDA determined that an anaerobic environment conducive to botulinum toxin formation is reasonably likely deeper in the non-hermetically sealed cans, especially under time-temperature abuse. * Hazard analyses did not distinguish between refrigerated and frozen products, and potential hazards for raw consumption