FDA WARNING_LETTER - The Sandwich Man, Inc. - May 19, 2011

On May 16-19, 2011, the FDA inspected The Sandwich Man, Inc. in Pearl River, Louisiana, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110). These violations render the firm's products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, "Shrimp & Crab Salad" and "Tuna Salad" sandwich products were found to be misbranded under Section 403 of the Act.

HACCP violations included failure to list allergens (fish, soy, eggs, wheat) as food safety hazards in HACCP plans for "Shrimp & Crab Salad" and "Tuna Salad" sandwiches, inadequate critical limits for controlling pathogen growth and toxin formation, and insufficient monitoring procedures for critical control points.

CGMP violations included the presence of ants and other insects in the kitchen and employees failing to wash hands thoroughly after touching unsanitized objects or after absences from the workstation. Environmental samples tested positive for *Listeria monocytogenes* in multiple locations, including standing water and a sandwich slicer wheel, indicating potential establishment of the pathogen in the facility and adulteration of products.

Labeling violations for "Shrimp & Crab Salad" and "Tuna