FDA WARNING_LETTER - U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods - April 08, 2010

On July 21, 2010, the FDA issued a Warning Letter to U.F.S. Industries, Inc. (d.b.a. Sally Sherman Foods) following an inspection from March 29 to April 8, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The FDA found that the company's refrigerated ready-to-eat (RTE) fishery products, including tuna salad, seafood salad, and cream cheese and lox, packed in oxygen-limiting containers, were adulterated. The HACCP plan for these products failed to list critical food safety hazards such as *Clostridium botulinum* growth and toxin formation, allergens, and scombrotoxin (histamine) formation for tuna salad. The packaging's oxygen transmission rate was insufficient to prevent *Clostridium botulinum* growth.

Additional violations included: * Failure to list critical control points for cooking and post-cook pre-mix cooling of scallops in seafood salad, and post-cook pre-mix cooling of lox in cream cheese and lox spread. * Inadequate critical limits for cooking the cream cheese and lox spread, lacking specificity on temperature type and cooking time. * Insufficient monitoring procedures for the "Cool