FDA published a letter sent to J.M. Smucker LLC about the inspection of their facility after the Salmonella outbreak

The FDA published a letter on their inspection of J.M. Smacker’s facility in Lexington, KY, on May 19, 2022, through June 9, 2022. The inspection was initiated after the outbreak of Salmonella Senftenberg (S. Senftenberg) illnesses linked to your ready-to-eat (RTE) peanut butter. According to the CDC, 21 people from 17 states were infected with the outbreak strain of S. Senftenberg. The product was recalled on May 20, 2022. Based on epidemiologic, laboratory, and traceback evidence, the CDC and FDA determined that peanut butter manufactured at Smacker’s facility was the source of a multistate S. Senftenberg outbreak. During the joint inspection, investigators found serious violations of the CGMP and PC rules. The investigators determined that the product was prepared, packed, or held under insanitary conditions. WGS identified five 2022 clinical isolates from ill people that matched environmental samples collected in 2010 from the Kentucky facility, indicating a resident strain. Smucker finished product testing records from January 1, 2021, to February 23, 2022, indicating that they detected Salmonella in the RTE peanut butter numerous times and that the corrective actions taken were insufficient to address the root cause of the contamination.@ https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023