FDA WARNING_LETTER - Valley Harvest Nut Company - July 31, 2009

On July 14-31, 2009, an FDA inspection of Valley Harvest Nut Company, Inc.'s almond processing facility revealed adulterated almonds under 21 U.S.C. 342(a)(4) due to insanitary conditions. Environmental samples showed **Salmonella senftenberg** in fourteen subsamples, with six distinct PFGE patterns, four of which were found in multiple locations, indicating a potential resident organism.

The inspection also found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110). Deficiencies included: 1. **Improper equipment and container handling (21 CFR 110.80(b)(7))**: Bins stored directly on the floor were stacked on bins containing roasted almonds without barriers. Dirty, hard-to-clean materials like cardboard and duct tape were used for equipment modifications and repairs. Forklifts traveled from outside directly into production areas without cleaning. 2. **Failure to exclude pests (21 CFR 110.20(b)(7) and 110.35(c))**: A hole in the processing room wall led directly outside. Numerous flies were observed on food product and contact surfaces. Rodent excreta droppings were found in the finished product storage room.

The company's August 5, 2009, response to the FDA-48