FDA WARNING_LETTER - Italco Food Products, Inc. - January 28, 2010

The FDA inspected Italco Food Products, Inc. from January 20-28, 2010, and found serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulations (21 CFR Part 123). These deviations render their vacuum-packaged smoked salmon, smoked trout, and pickled seafood salad in oil 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 primary violation is the firm's failure to conduct a hazard analysis and implement a written HACCP plan for these products to control the hazard of pathogen growth and toxin formation from *Clostridium botulinum*, as required by 21 CFR 123.6(a) and (b). The firm's February 16, 2010, response to the FDA 483 was deemed inadequate because it did not provide the required HACCP plans.

The FDA recommends assessing steps like receipt of refrigerated products and refrigerated finished product storage for temperature control, suggesting 24/7 temperature monitoring equipment. Failure to promptly correct these violations may result in regulatory actions, including product seizure or injunctions. The firm must respond in writing within 15 working days, outlining specific corrective actions, including HACCP plans and relevant records.