Inspectors found "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" and "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"
I tried to summarize this in a way to better focus on the issues. One primary point is that if there is a issue, using testing to resolve did not work.
There was a knock on the corrective action procedures in that Salmonella contamination was still being found - The " environmental monitoring records from 2021 revealed five Salmonella positive environmental swabs in your facility on July 6, July 8, July 12, September 3, and November 16, 2021. These Salmonella positive swabs were found on the floors near your blanch nut tank rooms, roaster booth (b)(4), the stairs at the top level of the nut house (b)(4), and the stairs leading to platform “(b)(4)”. The detection of Salmonella in your facility in 5 locations in 2021, many of which were similar to locations where you detected Salmonella in 2018 and 2019, show that your corrective action procedures in response to environmental contamination in 2018 and 2019 were not sufficient to reduce the likelihood that environmental contamination would recur, as required by 21 CFR 117.150(a)(2)(ii)."
FDA finishes the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023
- Through WGS (whole genome sequencing, "FDA identified five recent 2022 clinical isolates (samples collected from ill people) which matched over one hundred third-party peanut butter and environmental isolates from Kentucky collected from 2014 to 2017." "The presence of the same S. Senftenberg strain in [the] facility since 2010, which matched the clinical cluster, is indicative of a resident strain. "
- The company's "finished product testing records from January 1, 2021, to February 23, 2022, indicate that [the company] detected Salmonella in .... RTE peanut butter on numerous occasions, i.e., October 22 and December 15, 2021; and February 4, 9, 10, 20, and 21, 2022, and that [the company's] corrective actions were not sufficient to address the root cause of the contamination.
The issue - 'the establishment identified a leak in the air intake vent of the cooling chamber of Roaster as a source of water entering the equipment and that was repaired, however within a few days after the repair was completed, Salmonella was detected. Subsequently, additional samples were tested from the lot[s] produced immediately prior to and after the product that tested positive. testing found that that initially, lots tested negative for Salmonella but then identified two additional positive lots. The next day, Salmonella was detected in a lot. Similar to February 20, after testing lots that initially tested negative for Salmonella, additional lots tested positive.'
- The company indicated that when the additional samples test negative, they destroy all production lots to provide further assurance we have bracketed and eliminated any potential contamination.” "However, the positive test results for lots for which Salmonella was previously not detected show the limitations of reliance on [the]testing program to identify contamination as a way to prevent contaminated products from reaching consumers. Further, the S. Senftenberg outbreak shows that neither [the company's] corrective actions nor finished product testing was adequate to prevent contaminated product from reaching consumers and causing illnesses."
- The company responded on July 1, 2022 that they updated the finished product testing procedures to include a “Hold” procedure in the event a single positive result that is detected in RTE peanut butter where lots will be held ” produced (b)(4) hours before and (b)(4) hours after the affected (i.e., positive) lot and performing further testing using (b)(4) samples from only the (b)(4) lots on “each extreme of the bracketed window” (i.e., only the (b)(4) or (b)(4) lot on either end of the held product). The concern from FDA's letter is that this approach in response to a contamination event would not ensure all affected product would be identified and prevented from entering commerce. [FDA] is not aware of any data or scientific rationale to support how your (b)(4) Hold would be an effective approach to identify all product affected by a contamination event in your continuous production of RTE peanut butter.
So basically, you cannot test your way to safety. Salmonella should not be in that product period. And if product is positive, testing to determine what is safe is a gamble and there are bigger issues that have to be solved. In this case, tearing it all down and figuring out how it got there and then correcting the problem is the preventive approach.
Another interesting item was that the company did not identify Salmonella as a hazard in the post-process enviroment. From the report, the company " did not consider the hazard of recontamination with environmental pathogens, such as Salmonella spp., at post-roasting processing steps from blanching to sorting and milling (including (b)(4)). In-process RTE peanuts are exposed to the environment at these steps, and the food does not receive further treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen."
FDA finishes the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023
J.M. Smucker LLC
MARCS-CMS 638042 — JANUARY 24, 2023
MARCS-CMS 638042 — JANUARY 24, 2023
