Cucina Fresca, Inc. – FDA Warning Letter, Nov 2, 2009

On October 27-November 2, 2009, an FDA inspection of a food processing facility at 8300 Military Road South, Seattle, Washington, 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). These violations render the firm's seafood ravioli products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(2)):** The HACCP plan fails to list refrigerated storage as a critical control point (CCP) for controlling pathogen growth and toxin production in crab, lobster, and smoked salmon fillings used in ravioli. 2. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** Corrective action plans for crab, lobster, and smoked salmon ravioli at thawing and labeling CCPs do not describe steps to correct the cause of deviations. The lobster ravioli cooking CCP corrective action also fails to ensure affected product is not entered into commerce or that the cause of deviation is corrected. 3. **Failure to Implement Record Keeping (21 CFR 123.6(b) and (c)(7)):**