FDA WARNING_LETTER - K & S Wholesale Meat, Inc. - September 28, 2009

The FDA inspected K & S Wholesale Meat, Inc.'s seafood processing facility in Sun Prairie, WI, on September 16, 17, 24, and 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 regulation (21 CFR Part 110).

A primary violation was the firm's failure to have and implement a written HACCP plan to control reasonably likely food safety hazards, as required by 21 CFR 123.6(a) and (b). Specifically, there was no HACCP plan for shrimp to control undeclared sulfites on finished product labels, and no HACCP plan for various breaded seafood products (shrimp, whiting, Pollock, ocean perch, clam strips, cod, haddock) and crab cakes to control undeclared food allergens (e.g., wheat, soy, milk, crustaceans, fish, eggs) on finished product labels.

Additionally, the firm failed to maintain sanitation control records for the safety of water in contact with food or food contact surfaces, the storage and handling of toxic chemicals, and employee health control, violating 21 CFR 123.11(c). The investigator also noted that sanitation monitoring records had not been completed for several months.

These violations render the firm