FDA WARNING_LETTER - Culinaire Incorporated - June 22, 2009

On June 10-12, 15, 17-18, 22, 2009, the FDA inspected Culinaire Incorporated in Denver, Colorado, and found serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulation (21 CFR Part 123). These deviations render the firm's fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The FDA acknowledged Culinaire's July 10, 2009, response, which included descriptions of corrections and copies of four HACCP plans. However, the FDA determined the response was inadequate.

Key violations include: 1. **Inadequate Critical Limits (21 CFR Part 123.6(c)(3)):** * **Cooking/Lethality CCP-JB:** HACCP plans for "Lobster, crab, shrimp, scallops, Fish, Smoked Salmon canape (Fully Cooked)" and "Herbed Salmon, Poached Scallops, Herbed Halibut, Blackened Catfish (Fully Cooked)" listed a cook process achieving an internal temperature of (b)(4), which is insufficient to control *Salmonella*, *Listeria monocytogenes*, and *Clostridium botulinum*. The smoked