FDA WARNING_LETTER - 18th Street Deli, Inc - April 08, 2010

On August 24, 2010, the FDA issued a Warning Letter to 18th Street Deli, Inc. following an inspection from April 1-8, 2010, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat tuna salad, tuna pasta salad, and fish and cheese sandwich products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Inadequate HACCP Plan for Fish and Cheese Sandwiches:** The "Ready to Eat Products" HACCP plan lacked a critical control point for pathogen control during "Refrigerated Staging for Shipping," where products are stored for up to 48 hours. The revised plan did not adequately distinguish this from "refrigerated storage." 2. **Missing Food Safety Hazards:** HACCP plans for "Ready to Eat Products" and "Tuna/Tuna Pasta Salad" failed to list allergens as a reasonably likely hazard. The "Tuna/Tuna Pasta Salad" plan also omitted metal fragments. The firm's response did not address these omissions. 3. **Failure to Implement Record Keeping:** The firm did not consistently maintain temperature monitoring records for the Main Cooler at the Refrigerated Storage critical