FDA WARNING_LETTER - T & L Creative Salads, Inc. - October 27, 2014

On October 15-27, 2014, the FDA inspected T & L Creative Salads, Inc. in Brooklyn, NY, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The firm's refrigerated ready-to-eat fishery products, including various salads and wraps, were deemed adulterated due to insanitary conditions.

Despite the firm's submission of HACCP plans for tuna salad and seafood salads, the FDA identified significant deviations. The HACCP plan for crab and shrimp cakes failed to list "Deep Frying" as a critical control point for pathogenic bacteria growth, recommending a 6-log reduction of *Listeria monocytogenes*. Critical limits for pH in crab/shrimp cakes, seafood salad, and tuna fish salad were inadequate, only addressing the formulation blending step instead of the finished product.

Monitoring procedures were also deficient. For example, pH monitoring was only for each batch, not representative finished product samples. Time and temperature monitoring during processing and stabilization lacked sufficient detail and frequency. Allergen labeling monitoring was insufficient, requiring checks beyond just the start of new items.

Corrective action plans were deemed inappropriate. For pH deviations, plans lacked sufficient detail for accept/reject criteria and did not ensure the cause of the deviation was corrected. For pathogenic bacteria growth, corrective actions for time/temperature deviations did not ensure the cause