The J. M. Smucker Company, 1 Strawberry Ln, Orrville, OH 44667, United States

KY 40505-3728 from May 19, 2022, through June 9, 2022. The inspection was initiated as part of a multistate foodborne outbreak investigation of Salmonella Senftenberg (S. Senftenberg) illnesses linked to their ready-to-eat (RTE) peanut butter. According to the CDC, 21 people from 17 states were infected with the outbreak strain of S. Senftenberg. On May 20, 2022, this firm recalled all peanut butter manufactured at this facility from October 1, 2021, to May 20, 2022, due to potential contamination with Salmonella.

CDC and FDA have determined, based upon the epidemiologic, laboratory, and traceback evidence, that peanut butter manufactured at this facility was the source of this multistate S. Senftenberg outbreak.

At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA 483), Inspectional Observations. FDA received J.M. Smucker LLC responses to the FDA 483 dated July 1, 2022, August 1, 2022, August 16, 2022, and October 4, 2022, describing the corrective actions taken and planned by this firm, including training records associated with their implemented corrective actions. After reviewing the inspectional findings and their responses, FSA is issuing a warning letter to advise J.M. Smucker LLC of FDA’s continuing concerns and provide detailed information describing the findings at this facility.

Hazard Analysis and Risk-Based Preventive Controls
1. They did not identify and evaluate the hazard of contamination with environmental pathogens, such as Salmonella spp. at certain post-roasting processing steps, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control.

Their response to FDA on July 1, 2022, discussed actions their facility has taken to address the deficiencies with their food safety plan, including adding environmental recontamination with Salmonella as a hazard requiring a sanitation preventive control at all steps where RTE product is exposed to the environment and will not receive an additional kill-step. However, they did not provide a revised hazard analysis or food safety plan for FDA evaluation. As part of their response to this letter, the FDA request that they provide their current food safety plan (including their hazard analysis).

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

In their response dated July 1, 2022, they indicated that they conducted root cause investigations on the 2021 Salmonella findings in their facility, and they implemented corrective actions consistent with their environmental monitoring procedures. However, the outcomes of these investigations (e.g., their root cause determinations) were not provided in their response.

In addition, The FDA has the following comments:

The FDA is concerned that the history of contamination events associated with water in the facility and results from the whole genome sequencing (WGS) database suggest that Salmonella may be resident within your production facility.

While the procedures in the facility may help to identify events that would introduce water into your processing environment, constant vigilance is needed to ensure water does not become a source or route of cross-contamination in your dry processing environment. Further, to prevent Salmonella from spreading in their facility and adulterating their products, it is essential to identify the areas in their food manufacturing plant where Salmonella survives and take corrective actions as necessary to eradicate the organism.

In addition, the FDA recommends the company to consider incorporating WGS as a tool to investigate pathogen isolates obtained in their environmental monitoring program and/or their finished product testing program. The use of WGS to analyze and investigate any pathogen isolated from their production environment or RTE peanut butter will 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.

Source: www.fda.gov

About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction."