FDA WARNING_LETTER - LSG Sky Chefs - May 20, 2008

On August 28, 2008, the FDA issued a Warning Letter to LSG Sky Chefs following an inspection of their seafood processing facility in East Granby, Connecticut, conducted on May 16, 19, and 20, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

Specifically, the firm's HACCP plan for tilapia fillets and shrimp failed to list Clostridium botulinum toxin formation as a reasonably likely food safety hazard for raw fish in modified atmosphere packaging, regardless of initial oxygen levels. This renders their Tilapia Fillets and Shrimp meals adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

While the firm uses time/temperature indicators (TTIs), the FDA noted that TTIs are intended to alert consumers to unsafe conditions, not for monitoring temperature during storage or transit. The FDA recommends a critical limit of 38°F and continuous temperature monitoring with visual checks for all storage critical control points for seafood in modified atmosphere packages.

LSG Sky Chefs must respond in writing within fifteen working days, outlining specific corrective actions, including documentation like HACCP and verification records. Failure to