FDA WARNING_LETTER - Fiesta Gourmet and Deli - February 24, 2010

On February 12 and 24, 2010, the FDA inspected Fiesta Gourmet in Dearborn, Michigan, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's tuna salad sandwiches adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Specifically, Fiesta Gourmet failed to: 1. Conduct a hazard analysis and implement a written HACCP plan for refrigerated tuna salad sandwiches to control hazards such as histamine formation, allergens, and pathogen growth, violating 21 CFR 123.6(a) and (b). 2. Maintain sanitation control records documenting monitoring and corrections for the eight key areas of sanitation for tuna salad sandwiches, violating 21 CFR 123.11(c).

The FDA warns that failure to promptly correct these violations may result in further action, including product seizure and/or injunction against the firm's operation. Fiesta Gourmet must respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and verification records. The letter emphasizes the firm's responsibility to ensure compliance with the Act and all applicable regulations.