PepsiCo Inc. has received an FDA warning letter relating to their subsidiary, Quaker Oats. At issue are problems in their Danville, IL. plant that manufactured snacks including cereal bars. Deficiencies raised by FDA following trace-back investigations included failure to eradicate Salmonella Cubana from the environment and equipment in the plant extending back to 2020.

The FDA faulted management of the plant for “lack of effective decontamination to eliminate a resident strain of Salmonella”.  The internal surfaces of the plant allowed pooling of water and the presence of niches leading to extensive environmental contamination in violation of FDA standards.  On successive inspections FDA consistently demonstrated violations of the Current Good Manufacturing Practice, HACCP controls in accordance with the Human Food Rule.

Based on the series of FDA plant investigations followed by laboratory assay of samples collected, it was concluded that granola bars and RTE cereals were “adulterated” since they were prepared, packed and held under unsanitary conditions so as to become potentially injurious to health.

The FDA concluded that corrective action following the issuance of form FDA 483 did not result in appropriate action to reduce the likelihood of a continuation of contamination of products from the plant.

It is evident from the FDA warning letter that the decision to close the plant was justified based on the extensive and prolonged period of contamination resulting in salmonellosis among consumers of a range of granola bars produced in the facility. The question in this case and in many others is why the FDA prolongs investigations and delays definitive action contrary to their mission to protect the health of consumers.