FDA 483 - Setton Pistachio of Terra Bella, Inc. - April 30, 2009

The FDA Form 483 details significant violations at a pistachio processing facility. From October 2008 to March 2009, the firm continued to process and distribute roasted pistachio products despite repeated private laboratory results indicating Salmonella contamination. The firm failed to evaluate its roasting process adequacy or determine potential cross-contamination routes between raw and roasted pistachios.

Specific instances include shipping Salmonella-positive In-Shell Roasted/Salted Pistachios in October 2008, which were returned, re-roasted, and blended into other products for distribution. Similarly, Roasted/Salted Pistachio Kernels and In-shell Roasted/Salted Pistachios shipped in March 2009 were later found positive for Salmonella. At least eight Salmonella-positive test results were reported by four third-party laboratories during this period.

The firm lacked adequate quality control operations and procedures to respond to positive Salmonella samples. Deficiencies in plant construction and design were noted, including a large roof gap (4'x1') and two 2"x6" gaps above the commercial roaster, with rusty, broken ceiling parts and thick dust/debris.

The roasting process lacked adequate controls to destroy microorganisms; roasting temperatures, time, and pistachio depth were not monitored before January 2009, and temperature devices/belt speeds were uncalibrated. Roasters used for raw pistachios were also used for re-roasting previously adulterated lots.

Cross-contamination risks