The firm was involved in a recall of pistachios due to Salmonella in summer last year.
Failure to correct the violations may result in enforcement action, seizure and/or injunction. The firm has until the 28 January to respond.
Epidemiological data from the outbreak investigation coupled with inspection findings and analyses from product and environmental samples indicate that pistachios were the likely source of the Salmonella outbreak, according to the warning letter.
In early 2013, prior to a 21-24 May inspection, the firm was associated with three Reportable Food Registry (RFR) reports that detailed positive Salmonella findings detected in two distributed shipments of raw pistachios.
The letter set out some of the violations seen during the inspection.
“An employee in your 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.”
The letter said apparent bird droppings were observed on the floor of the outside areas where maintenance personnel were seen working and entering the hand sorting room.
“Inside the hand sorting room, two buckets containing floor sweepings of pistachios, dust, and debris, were observed near the hand sorting production lines. During the inspection, you stated that the buckets of floor swept pistachios will be reworked into finished product.”
During the inspection, environmental samples were collected from within the processing facility and analyzed.
The analysis revealed the presence of Salmonella enterica serotype Senftenberg (S. senftenberg) in seventeen subsamples.
Pulsed Field Gel Electrophoresis (PFGE) testing determined that a single PFGE pattern of S. senftenberg was present in the facility and the pattern was in multiple locations, said the letter.
“The recovery of the same S. senftenberg serotype from multiple locations within your facility is a significant concern because it indicates that the pathogen is a potential resident organism in your facility,” said the FDA.
“Further, finding Salmonella very near to where food is exposed, including numerous product contact surfaces, indicates a high risk of product contamination.”