FDA WARNING_LETTER - Cuisine Solutions, Inc. - July 01, 2008

On June 30 - July 1, 2008, the FDA inspected Cuisine Solutions, Inc.'s seafood processing facility in Alexandria, VA, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their seared salmon adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the firm's HACCP plan for "Cooked Seafood" was deficient in two key areas: 1. **Inadequate Critical Limit for Cooking:** The critical limit of "Minimum internal temperature during cooking shall reach 60°C (140°F)" at the "cooking" critical control point is insufficient to control *Clostridium botulinum* growth and toxin formation, as 140°F is not adequate to prevent spore germination and toxin production. The plan also lacked a specified cook time. FDA recommends a cook temperature and time combination to achieve a 6D reduction in *C. botulinum*. 2. **Missing Critical Control Point for Cooling:** The HACCP plan did not list "cooling" as a critical control point to control pathogen contamination after cooking. This is a concern because contaminated cooling water can enter product containers during water bath cooling if closures are defective, especially since the seared salmon is packaged before cooling.

The firm's July 2