Quaker Oats granola bars and cereals were prepared, packed or held under insanitary conditions and are thereby Adulterated

WARNING LETTER
CMS #679972

June 12, 2024

Dear Mr. Laguarta:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility located at 1703 East Voorhees Street, Danville, IL 61834 from December 19, 2023, through February 2, 2024. Your facility manufactures RTE granola bars and RTE cereals. During the inspection of your 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), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). This inspection was initiated in response to a Reportable Food Registry (RFR) report and recall of your granola bars and granola cereals announced on December 15, 2023. FDA also collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Salmonella Cubana, a human pathogen, in your facility.

Based on FDA’s inspectional findings and analytical results for the swabs collected at your facility, we have determined that the RTE granola bars and cereals manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby 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 (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links on FDA’s website at http://www.fda.gov.

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

Reportable Food Registry Report and Recall

The Quaker Oats Danville facility (you) performed (b)(4) finished product testing of your chewy granola bars from (b)(4) Chewy lines in the facility (i.e., Chewy (b)(4)). On November 22 and 23, 2023, you collected a (b)(4) sample of “Chewy Chocolate Chip Granola Bars” from Chewy Line (b)(4), which was reported as a presumptive positive on November 25, 2023. The positive sample was later confirmed on December 11, 2023, following an investigation of a suspected (but not confirmed) laboratory error concerning the initial results. On December 12, 2023, your corporate Research & Development laboratory in Plano, TX, confirmed the finished product sample as positive for Salmonella Cubana and that the isolate matched (via (b)(4)) previous isolates identified in the facility during your routine environmental monitoring of areas upstream to Chewy Lines (b)(4)on as recently as September 7 and October 4, 2023, near the (b)(4) and the RTE area on the (b)(4) floor, respectively. On December 14, you notified FDA of your decision to recall specific granola bars and granola cereals due to the potential of being contaminated with Salmonella and filed an RFR report. We remind you that under Section 417(d) of the Act [21 U.S.C. 350f(d)], an RFR report must be filed within 24 hours of determination of a reportable food.

On December 19, 2023, FDA collected samples (environmental swabs) of your 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 (b)(4); 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 SalmonellaCubana and the isolate did not match other food, environmental, or clinical isolates in the database. We advised you of the WGS results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of SalmonellaCubana has survived since 2020.

On January 11, 2024, your laboratory analysis identified that Salmonella Cubana that originated in the (b)(4) Room and contaminated the granola line had spread to (b)(4)areas of the extruded RTE cereal line, (b)(4). This included areas where extruded material is exposed to the environment without an additional kill-step. That same day you expanded your 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 (21 CFR Part 117, Subpart C)

Your corrective action procedures did not ensure appropriate action was taken, when necessary, to reduce the likelihood that environmental contamination will recur, as required by 21 CFR 117.150(a)(2)(ii), when you detected Salmonella in your facility’s environment.

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

Your records of corrective actions included cleaning/sanitizing the affected area and additional (b)(4) swabbing, but they did not include corrective actions that that would have reduced the likelihood that the problem would recur. For example, your “Pathogen Environmental Monitoring (PEM)” investigation worksheet dated September 15, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways on the floor under the (b)(4) and at the “sandwich point” (b)(4) in the (b)(4)Room on the (b)(4) floor (zone (b)(4) areas) but did not consider other areas as potential sources of contamination. Your PEM investigation worksheet dated October 11, 2023, identified potential harborages or niches associated with buildup or water pooling in pathways (b)(4). Your 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, your corporate PEM program states that “repeat positive results typically indicate further deep dive,” but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., “deep dive” corrective actions) were taken at your facility.

The repeated findings of Salmonella Cubana in your facility demonstrate that your corrective action procedures taken in response to environmental contamination in 2022 and before November 2023 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii). It is essential to identify the areas of the food processing plant where 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.

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

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

Your 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 by 21 CFR 117.40(a)(1).

(b)(4).

Previous to notifying FDA on April 3, 2024, of your intention to cease operations at the Danville facility, you acknowledged gaps in the (b)(4), which is (b)(4). You stated that you were evaluating approaches to modify this system if you resumed use of the (b)(4)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. You also stated that you were considering design and product flow changes to the equipment that will improve raw to RTE segregation.

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

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

In addition, we have the following comment:

We recommend that you consider incorporating WGS as a tool to investigate pathogen isolates obtained in your environmental monitoring program and/or your finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from your production environment or RTE food products would provide the most complete information available to identify and implement appropriate and effective corrective actions, including steps to prevent the contamination from recurring and steps to ensure contaminated product does not enter commerce.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Lauren Crivellone, Compliance Officer, 550 W. Jackson Blvd., Chicago, IL 60661. If you have any questions about this letter, please contact Lauren Crivellone 312-206-5264 or via e-mail at Lauren.Crivellone@fda.hhs.gov.

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food East
Division 6

Cc: Mr. Steven Williams, CEO
PepsiCo Foods North America
7701 Legacy Drive
Plano, Texas 75024
Steven.Williams@pepsico.com

Mike Klein, Site Director
The Quaker Oats Company
1703 E. Voorhees St.
Danville, IL 61834
Mike.Klein@pepsico.com

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.