The Food and Drug Administration has sent a warning letter to ARO Pistachios Inc. related to allegedly unresolved issues found during inspections at the company, which recalled its entire 2012 crop of pistachios because of potential contamination and links to a salmonella outbreak.
Adam Orandi, president of Terra Bella, Calif.-based ARO Pistachios, did not immediately respond to requests for comment on the Jan. 13 warning letter. He has 15 days to reply to the FDA. If issues are not resolved, the FDA could take action without further notice, including seizure and injunction, according to the letter.
The warning letter includes comments Orandi made to FDA during a three-day investigation in May.
“… you stated that the buckets of floor swept pistachios will be reworked into finished product,” according to the warning letter. The FDA collected 17 environmental samples from the ARO facility that tested positive for salmonella.
“In addition, a cluster of salmonellosis infections reported from January through May 2013, … and analyses from product and environmental samples collected from your processing facility indicate that pistachios were the likely source of the salmonella outbreak,” according to the warning letter.
Because of the salmonella outbreak, the FDA inspected ARO’s facility in March and April of 2013, in addition to the May inspection referenced in the warning letter, said agency spokesman Dave Steigman.
In July, Orandi told The Packer he was not aware of any illnesses related to ARO pistachios. At that time he said ARO customers and the FDA worked together to recall products and he had initiated a root-cause analysis at the Terra Bella facility.
Three of ARO’s customers initiated pistachio recalls in relation to the salmonella situation. Western Mixers Produce & Nut Co. and Torn & Glasser Inc., both based in Los Angeles, recalled a variety of pistachio pack styles and sizes. Christophers Nut Co., Van Nuys, Calif., recalled all ARO processed pistachios from the 2012 season.
ARO’s voluntari recall, initiated June 4, included more than 550,000 pounds of pistachios — it’s entire 2013 crop. FDA documents report two shipments of ARO’s raw pistachios tested positive for salmonella.
FDA’s warning states the ARO facility “has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods.”
“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,” according to the warning letter.