Florida Key West, Inc. – FDA Warning Letter, Sep 12, 2016

On August 31, 2016, through September 12, 2016, the FDA inspected Florida Key West, Inc. at 3150 County Road, Suite 1, Lakeland, FL 33811, and found significant deviations from the Juice Hazard Analysis and Critical Control Point (HACCP) regulation [21 CFR Part 120]. This renders their lemon and lime juice products adulterated under Section 402(a)(4) of the Food, Drug, and Cosmetic Act.

The firm lacks written hazard analyses and HACCP plans for their reconstituted 100% lemon and lime juice products to control microorganisms, violating 21 CFR 120.7(a) and 120.8(a). Additionally, they do not include control measures in their hazard analysis and HACCP plan to consistently achieve a 5-log reduction of the pertinent microorganism, as required by 21 CFR 120.24(a).

The firm's October 12, 2016, response was inadequate as it did not include specific written hazard analyses or HACCP plans for their juice products and processing operation. The firm cannot rely on HACCP documentation or 5-log reduction data from foreign suppliers to satisfy their own processing facility's requirements, as 21 CFR 120.24(c) mandates the