FDA WARNING_LETTER - ARO Pistachios, Inc. - May 24, 2013

On May 21-24, 2013, the FDA inspected ARO Pistachios, Inc.'s facility in Terra Bella, CA, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), rendering pistachio products adulterated under 21 U.S.C. § 342(a)(4).

Prior to the inspection, the firm was linked to three Reportable Food Registry reports of *Salmonella* in raw pistachios. Environmental samples collected during the inspection revealed *Salmonella enterica serotype Senftenberg* in seventeen subsamples, indicating a potential resident organism and high risk of product contamination, especially on product contact surfaces. Epidemiological data from a January-May 2013 salmonellosis outbreak, combined with inspection findings and sample analyses, suggest pistachios from ARO Pistachios were the likely source, also adulterating products under 21 U.S.C. § 342(a)(1).

A significant violation cited was the failure to protect work-in-process from contamination (21 CFR 110.80(b)(5)). Specifically, an employee touched shipping boxes on the floor and then roasted pistachios without hand washing. Additionally, maintenance personnel entered the hand sorting room from outside, where bird droppings were observed, potentially introducing contaminants, especially since floor-swept pistachios were reworked into finished product