FDA WARNING_LETTER - Seco Spice Ltd. Co. - November 09, 2011

The FDA conducted an inspection of Seco Spice Ltd.'s chili pepper and spice manufacturing facility from October 31 to November 9, 2011, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). Environmental sampling revealed the presence of *Salmonella* in twenty-one subsamples from processing locations, including areas where food is exposed. This was a repeat finding from a 2009 inspection, with PFGE analysis indicating the same *Salmonella anatum* strain, suggesting a persistent niche environment.

These findings led the FDA to determine that the firm's food products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. The FDA expressed concern that the firm's proposed corrective action of twelve swabs with a third-party consultant was insufficient.

Additional CGMP violations included: 1. Failure to use an adequate water supply (unprotected well access port and outlet valves). 2. Failure to maintain sanitary conditions (dead beetle-like insects and live larvae on product totes). 3. Lack of hand-washing facilities with suitable temperature running water (no hot water in processing area sinks). 4. Failure to provide adequate pest protection (open pedestrian and dock doors during sanitation). 5. Failure to provide sanitary towel service