FDA EIR - J.M. Smucker LLC - June 24, 2010

An FDA inspection of JM Smucker LLC's Lexington, KY facility, a JIF peanut butter manufacturing plant, was conducted from June 21-24, 2010. The inspection, guided by the "Domestic Food Safety" regulatory framework and a high-priority work plan for nut product firms, aimed to assess various systems including sanitation, raw materials, and manufacturing processes. While no formal FDA 483 was issued, the inspection identified several areas requiring attention. Key issues included an employee leaving the production area in sanitary attire and returning without changing, an employee manually righting fallen jars on the production line, improperly positioned sanitation pans at entryways, and the absence of a wash station in a specific production room. Significantly, two environmental samples tested positive for Salmonella genus. The firm also declined to share internal quality control and lab testing results. In response, JM Smucker LLC committed to voluntary corrections and actions, including repositioning sanitation pans, implementing color-coded brooms for dedicated areas, reinforcing hygiene policies for staff and contractors, addressing the manual handling of jars, and installing the missing wash station. One Salmonella positive was linked to a broom used externally.