Triple D Orchards, Inc. – FDA Warning Letter, Sep 21, 2011

On January 5, 2012, the FDA issued a Warning Letter to Triple D Orchards, Inc. following inspections of their juice processing facility from August 31 to September 9, 2011, and on September 21, 2011. The inspection revealed serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The FDA determined that Triple D Orchards' tart cherry juice product is adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act because it was prepared, packed, or held under insanitary conditions.

Significant juice HACCP violations include: 1. Failure to have a written HACCP plan for tart cherry concentrate, as required by 21 CFR 120.8(a). 2. Lack of a written hazard analysis to identify food safety hazards and control measures, as required by 21 CFR 120.7(a). A 2009 commitment to develop these was not fulfilled. 3. Failure to perform a 5-log reduction of pertinent microorganisms in cherry juice concentrate, as required by 21 CFR 120.24(a), (b), and (c).