The FDA sent a Warning Letter this month to ARO Pistachios, Inc. after an outbreak of Salmonella food poisoning was linked to pistachios and an inspection of the ARO processing facility found “serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).”
From January through May of 2013, Salmonella infections (salmonellosis) were investigated by local, state, and federal public health and regulatory agencies. The FDA determined that pistachios were the likely source of the Salmonella outbreak based on the following:
- Epidemiological data (interviews with ill persons)
- Analyses from product and environmental samples collected from the ARO Pistachios processing facility indicate that pistachios were the likely source of the Salmonella outbreak.
Prompted by the Salmonella outbreak, the FDA conducted the inspection of the ARO Pistachio processing facility inspection on May 21st through May 24th, 2013. The pistachio processing facility is located at 19570 Avenue 88, Terra Bella, California 93270. During the inspection, FDA found evidence that the company failed to protect against contamination and thereby violated the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110):
- An employee in the pistachio roasting room was observed repeatedly touching the bottom of shipping boxes that were resting on the floor and then touching roasted, ready-to-eat, pistachios without washing or sanitizing hands.
- Maintenance personnel were observed entering and exiting the hand sorting room through a door that opens directly to the outside of the facility, where there were bird droppings (a potential source of Salmonella bacteria) on the floor. Inside the hand sorting room, the FDA observed two buckets containing floor sweepings of pistachios, dust, and debris near the hand sorting production lines. FDA investigators were told by company employees that the buckets of floor-swept pistachios would be reworked into finished product. The FDA Warning Letter stated, “The movement of employees from the outside of the facility (where apparent bird droppings were observed) into the hand sorting room may introduce contaminants into your facility and contaminate finished food, particularly based on your practice of reworking pistachios from the floor.”
The FDA determined that the above Violations rendered the pistachio products “adulterated” within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FFD&C Act), 21 U.S.C. § 342(a)(4) “in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”The FDA Warning Letter also pointed out that in early 2013, the company was associated with three Reportable Food Registry (RFR) reports that detailed positive Salmonella findings detected in two shipments of raw pistachios distributed by the company.
These findings prompted an inspection (prior to the May 2013 inspection) of the ARO Pistachio processing facility. Environmental samples were collected from various locations within the processing facility and were then analyzed. The analysis revealed the presence of Salmonella Senftenberg (Senftenberg is the serotype) in seventeen (17) subsamples. These Salmonella Senftenberg isolates were then tested with Pulsed Field Gel Electrophoresis (PFGE), which found the DNA “fingerprint” (PFGE pattern) of the bacterial isolates. The analysis found that a single PFGE pattern of Salmonella Senftenberg was present in the facility and that the pattern was present in multiple locations within the facility. This is a significant concern because it indicates that the pathogen is a potential resident organism in the facility, according to the FDA.
