FDA WARNING_LETTER - CFM dba Your Deli - July 28, 2009

On November 27, 2009, the FDA issued a Warning Letter to CFM dba Your Deli following an inspection from July 23-28, 2009. 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 (CGMP) regulation (21 CFR Part 110).

The firm's Tuna Salad Sandwiches were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for tuna salad sandwiches to control food safety hazards such as allergens and pathogen growth, violating 21 CFR 123.6(a) and (b). 2. **Inadequate Sanitation Monitoring:** The firm did not sufficiently monitor the exclusion of pests, violating 21 CFR 123.11(b) and 21 CFR Part 110. Specific observations included a live spider on a tuna salad sandwich, small flies throughout the processing room, and an unidentified live insect on a wall.

Additionally, the facility had not registered with the FDA as required by Section 41