FDA WARNING_LETTER - PepsiCo, Inc. - February 02, 2024

The FDA inspected Quaker Oats' RTE food manufacturing facility in Danville, IL, from December 19, 2023, to February 2, 2024, following a Reportable Food Registry (RFR) report and recall of granola bars and cereals on December 15, 2023. The inspection found serious violations of the CGMP & PC rule (21 CFR Part 117).

FDA laboratory analyses of environmental swabs confirmed the presence of *Salmonella Cubana*, a human pathogen. This, combined with inspectional findings, led the FDA to determine that the RTE granola bars and cereals were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], as they were prepared, packed, or held under insanitary conditions. Failure to comply with preventive controls is also prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)].

The company's finished product testing on November 22-23, 2023, yielded a presumptive positive for *Salmonella Cubana* in "Chewy Chocolate Chip Granola Bars," confirmed on December 11, 2023. This isolate matched previous isolates found in the facility's environmental monitoring