FDA WARNING_LETTER - J.M. Smucker LLC - June 09, 2022

The FDA and Kentucky CHFS-FSB jointly inspected J.M. Smucker Co.'s Lexington, KY facility from May 19 to June 9, 2022, following a multistate *Salmonella Senftenberg* outbreak linked to their ready-to-eat (RTE) peanut butter, which infected 21 people across 17 states. The firm recalled affected peanut butter on May 20, 2022. Epidemiologic, laboratory, and traceback evidence confirmed the facility as the outbreak source, indicating adulterated product was introduced into interstate commerce, violating section 301(a) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering the RTE peanut butter adulterated under section 402(a)(4) of the Act. Failure to comply with preventive controls is also prohibited by section 301(uu).

Key violations include: 1. **Inadequate Hazard Analysis:** The firm failed to identify and evaluate environmental pathogen contamination, specifically *Salmonella spp.*, at post-roasting processing steps (blanching, sorting, milling) as a known or foreseeable hazard requiring a preventive control (21 CFR 117.130(c)(1)(ii)).