The U.S. Food and Drug Administration warned a Californian firm to fully document any manufacturing changes it makes, so that two Salmonella strains found in its pistachios, and linked to a multistate outbreak this past spring will not recur.
The FDA warning letter, dated Oct. 7, was addressed to Stewart Resnick, owner of The Wonderful Company, based in Los Angeles, and concerned Wonderful Pistachios processed by Paramount Farms at 13646 Highway 33 in Lost Hills, CA, about 45 miles northwest of Bakersfield.
The outbreak sickened at least 11 people in nine states and hospitalized two of them. No deaths were reported, according to a final update from the U.S. Centers for Disease Control and Prevention, posted May 20.
On March 9, The Wonderful Company recalled various flavors and sizes of in-shell and shelled pistachios, sold under the brand names Wonderful, Paramount Farms and Trader Joe’s. The recalled nuts were sold nationwide and in Canada, Mexico and Peru.
Although CDC declared the outbreak investigation over back in May, since the recalled pistachios have a long shelf life and may still be in people’s homes, the agency noted that consumers unaware of the recall could continue to eat the products and get sick.
FDA’s San Francisco District Office in Alameda told Resnick in the warning letter that, following the Salmonella outbreak, investigators had inspected the company’s pistachio manufacturing process at the Lost Hills facility from March 8 through April 7.
During FDA’s visit to Paramount Farms, inspectors collected three product samples, each consisting of 30 subsamples. In one sample of raw, in-shell pistachios collected from the facility’s silos, five of 30 subsamples yielded positive tests, four for Salmonella Senftenberg and one for Salmonella Liverpool, according to the warning letter.
The agency’s letter acknowledged The Wonderful Company recall of pistachio products and its written response to the inspection observations, dated April 19. In that response, the company proposed to study the optimal chlorine level in its processing tanks and install a system to remove foreign material, prior to moving the pistachios into storage, the warning letter stated.
“However, you did not provide us with documentation demonstrating the effectiveness of these changes and any other changes you have made to prevent a reoccurrence of an outbreak,” FDA noted, adding that it would need documentation, including photographs, of corrective actions taken to date and any other pertinent information that might help evaluate such corrections.
As of Thursday, FDA had not yet heard back from Resnick, The Wonderful Company or Paramount Farms, said Sergio Chavez, a compliance officer with the agency’s Alameda office. However, he pointed out that they have 15 working days from receiving the letter to do so.
In response to a request from Food Safety News, Steven Clark, vice president of corporate communications for The Wonderful Company, provided this statement regarding the warning letter:
“Yes, we were surprised to receive this communication from the FDA since we have not heard from them since early April when they inspected our facility. Other than the Oct. 7 letter, neither the FDA nor the CDC advised us of any further action required on our part. Moreover, the CDC closed their investigation last May.
“Though none of the Salmonella cases in question were directly linked to our product, we did voluntarily recall product in an abundance of caution, we implemented enhanced food safety protocols, and no new issues have surfaced. We will continue to cooperate with the FDA to satisfy any concerns they may have.”
