January 24, 2023
WARNING LETTER 638042
Dear Mr. Smucker:
The U.S. Food and Drug Administration (FDA) and the Kentucky Cabinet for Health and Family Services Food Safety Branch (CHFS-FSB) jointly inspected your manufacturing facility located at 767 Winchester Road, Lexington, 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 your ready-to-eat (RTE) peanut butter. According to the Centers for Disease Control and Prevention (CDC), 21 people from 17 states were infected with the outbreak strain of S. Senftenberg. On May 20, 2022, your 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 your facility was the source of this multistate S. Senftenberg outbreak. Further, the evidence establishes that you introduced adulterated peanut butter into interstate commerce as prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 331(a)].
FoodWorld 