The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

PepsiCo Inc.
Purchase, NY

The FDA has issued a warning letter to PepsiCo Inc. about its now-closed Quaker Oats facility in Danville, IL. The letter revealed a history of positive Salmonella tests dating back to 2020, with a strain matching the one responsible for the recall of Quaker Oats products in 2023 and 2024.

The Quaker Oats recall began on Dec. 15, 2023, with more than 40 products implicated. The recall was expanded on Jan. 12, 2024, with two dozen more products pulled.

The company closed its manufacturing facility in Danville, IL in June of this year. The company has shifted production of products made at the plant to other facilities. 

In a June 12, 2024, warning letter, the FDA described a Dec. 19, 2023, through Feb. 2, 2024, inspection of PepsiCo Inc.’s manufacturing facility in Danville, IL.

The facility manufactures ready-to-eat (RTE) granola bars and RTE cereals. During the inspection of their facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (CGMP & PC rule). This inspection was initiated in response to a Reportable Food Registry (RFR) report and recall of their granola bars and granola cereals announced on Dec. 15, 2023. FDA also collected environmental samples (i.e., swabs) from various areas in their processing facility. FDA laboratory analyses of the environmental swabs found the presence of Salmonella Cubana, a human pathogen, in their facility.

based on FDA’s inspectional findings and analytical results for the swabs collected at their facility, the FDA has determined that the RTE granola bars and cereals manufactured in their facility are adulterated because they were prepared, packed, or held under insanitary conditions wherby they may have become contaminated with filth or wherby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule is prohibited.

After the inspection, the FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at their facility. The FDA received their written response dated Feb. 23, 2024, which included statements regarding the evaluation of the violations and promised future corrections and received further information regarding their intentions for the facility dated April 3. After reviewing the inspectional findings and the response provided by their firm, the FDA is issuing this letter to advise the firm of FDA’s concerns and provide detailed information describing the findings at their facility.

Some of the significant violations are as follows:

Reportable Food Registry Report and Recall

The Quaker Oats Danville facility performed (redacted by FDA) finished product testing of their chewy granola bars from (redacted by FDA) Chewy lines in the facility (i.e., Chewy (redacted by FDA)). On Nov. 22 and 23, 2023, the firm collected a (redacted by FDA) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (redacted by FDA), which was reported as a presumptive positive on Nov. 25, 2023. The positive sample was later confirmed on Dec. 11, 2023, following an investigation of a suspected (but not /confirm/ied) laboratory error concerning the initial results. On Dec. 12, 2023, their corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (redacted by FDA)) previous isolates identified in the facility during their routine environmental monitoring of areas upstream to Chewy Lines (redacted by FDA) on as recently as Sept. 7 and Oct. 4, 2023, near the (redacted by FDA) and the RTE area on the (redacted by FDA) floor, respectively. On Dec. 14, the firm notified FDA of their decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report. The FDA reminds the firm that an RFR report must be filed within 24 hours of determination of a reportable food.

On Dec. 9, 2023, FDA collected samples (environmental swabs) of the firm’s production environment. FDA analysis of sample INV 1234817 confirmed one swab was positive for Salmonella spp. The swab was collected in a crack on the floor in the (redacted by FDA); the investigator noted that apparent food residue was observed at the sampling location. Whole genome sequencing (WGS) was conducted on the Salmonella isolate obtained from the FDA environmental swabs. The WGS analysis confirmed the isolate to be Salmonella Cubana and the isolate did not match other food, environmental, or clinical isolates in the database. The FDA advised the firm of the WGS results via a conference call on Jan. 3, 2024. They acknowledged that they had identified historical isolates of Salmonella Cubana in their facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020.

On Jan. 11, 2024, the firm’s laboratory analysis identified that Salmonella Cubana that originated in the (redacted by FDA) Room and contaminated the granola line had spread to (redacted by FDA) areas of the extruded RTE cereal line, (redacted by FDA). This included areas wher extruded material is exposed to the environment without an additional kill-step. That same day the firm expanded their recall to cover all RTE cereals, bars, and snacks within shelf-life manufactured at the Danville facility or manufactured with ingredients manufactured at the Danville facility.

Hazard analysis and risk-based preventive controls

The firm’s corrective action procedures did not ensure appropriate action was taken, when necessary, to reduce the likelihood that environmental contamination will recur, as required, when the firm detected Salmonella in their facility’s environment.

The firm found Salmonella Cubana in 13 environmental samples since June 2022, including on Sept. 7, 2023, and Oct. 4, 2023. The positive swabs were located on floors (redacted by FDA) of the facility, including the (redacted by FDA), the RTE area on the (redacted by FDA), and Quaker Natural Granola areas (redacted by FDA). All (redacted by FDA) of these Salmonella Cubana isolates share the same pattern via (redacted by FDA) conducted by their firm. Finding Salmonella Cubana with the same (redacted by FDA) pattern over this period of time indicates they likely had a resident strain, and they should have developed their corrective actions accordingly.

The firm’s records of corrective actions included cleaning/sanitizing the affected area and additional (redacted by FDA) swabbing, but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, their “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated Sept. 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (redacted by FDA) and at the “sandwich point” (redacted by the FDA) in the (redacted by FDA) Room on the (redacted by FDA) floor (zone (redacted by FDA) areas) but did not consider other areas as potential sources of contamination. The firm’s PEM investigation worksheet dated Oct. 11, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways (redacted by FDA). The firm’s root cause analysis identified the leaking HVAC pipe as the source of water in the area, but a leaking pipe would not be the source of Salmonella. Furthermore, their corporate PEM program states that “repeat positive results typically indicate further deep dive,” but they did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., “deep dive” corrective actions) were taken at their facility.

The repeated findings of Salmonella Cubana in their facility demonstrate that their corrective action procedures taken in response to environmental contamination in 2022 and before Nov. 2023 were not sufficient to reduce the likelihood that environmental contamination would recur, as required. It is essential to identify the areas of the food processing plant wher Salmonella can survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

The FDA received the firm’s notice dated April 3, 2024, stating their intention to cease operations at the Danville facility. However, they have other manufacturing facilities and should evaluate if such corrective actions are necessary in their other plants to reduce the likelihood of a similar event. Furthermore, given the apparent ongoing contamination of Salmonella Cubana in the Danville facility, special care should be taken if they determine that any equipment or utensils from the Danville facility can be safely utilized at other food manufacturing facilities.

Current Good Manufacturing Practice

The firm’s plant equipment and utensils used in manufacturing and processing were not designed and of such material and workmanship as to be adequately cleanable, or adequately maintained to protect against contamination, as required.

(Redacted by FDA).

Previous to notifying FDA on April 3, 2024, of their intention to cease operations at the Danville facility, they acknowledged gaps in the (redacted by FDA), which is (redacted by FDA). The firm stated that they were evaluating approaches to modify this system if they resumed use of the (redacted by FDA) equipment at the facility, including using a combination of timing and recirculation to prevent downstream contamination and completing run time studies to scientifically define appropriate run times with a combination of intermittent and extensive cleaning. The firm also stated that they were considering design and product flow changes to the equipment that will improve raw to RTE segregation.

Although the firm intends to cease operations at the Danville facility, they have other manufacturing facilities and should evaluate if similar corrective actions are necessary in their other plants to reduce the likelihood of contamination.

The full warning letter can be viewed here.