FDA Blasts PepsiCo for Response to Salmonella Positives Over Four Years at Quaker Oats Danville, Illinois, Plant

The U.S. Food & Drug Administration (FDA) sent a scathing warning letter to Quaker Oats parent company PepsiCo Inc. this week, blasting the company’s lax food safety and sanitation response after a massive recall of numerous varieties of Quaker granola bars and cereals produced out of its now-shuttered Danville, Ill., processing facility, where Salmonella may have been present in the processing environment for the past four years.

FDA noted in the warning letter that it had inspected the Danville facility from Dec. 19, 2023, through Feb. 2, 2024, during which time it found Salmonella Cubana, a strain considered to be a human pathogen, in swabs taken in various areas of the facility.

Of particular note to FDA was a swab taken of a crack in the floor where an investigator also noted the present of apparent food residue. Salmonella Cubana was found in that sample, and in the follow-up to whole-genome sequencing (WGS) performed on the isolate, representatives of the Danville facility acknowledged that they had identified historical isolates of Salmonella Cubana there since at least 2020 — meaning the same strain of the pathogen may have survived in the facility for four years.

FDA then turned its focus toward the plant’s food safety and pathogen elimination tactics, scolding the company for not taking appropriate corrective actions even as the positive samples continued to show up. Since June 2022, the letter noted, 13 samples tested positive for Salmonella Cubana in the plant. FDA claimed the Danville facility may have cleaned and sanitized the affected area, and may have performed additional testing, but no corrective actions were taken to reduce any recurrence of the pathogen, even though the facility’s own “Pathogen Environmental Monitoring” program called for a “deep dive” when repeat positive results occurred.

Finally, FDA dropped the hammer that closing the facility was not akin to sweeping any food safety and sanitation shortcomings for the company under the rug. Quaker/PepsiCo announced in April that it would shut the facility down and shift production to other facilities in the network. The shutdown cost more than 500 employees their jobs, as the plant was one of the largest employers in the area.

The FDA warned the company to evaluate if similar issues exist at its other facilities and if corrective actions were necessary to reduce the likelihood of a similar event. In addition, FDA advised that equipment and tools from the Danville facility should be handled with “special care” in order to prevent the spread of Salmonella Cubana to other facilities if the company planned to move and use that machinery in its other facilities.

Lastly, FDA advised Quaker/PepsiCo to consider using WGS as part of its environmental monitoring program or finished product testing program, as a tool to assist in response to any positive pathogen findings.

The Danville Quaker Oats plant produced Quaker Chewy Bars and RTE cereals, and was the production facility associated with a significant recall of Quaker Chewy Bars varieties in December 2023 — which was expanded twice in January 2024 to include more cereal bars, snack bars and some RTE cereals.