Mars Petcare, Inc – FDA EIR, Jun 15, 2023

An FDA comprehensive preventive controls inspection was conducted at Mars Petcare, Inc. in Leipsic, OH, from June 13 to June 15, 2023. This inspection, carried out under Compliance Program 7371.000 for animal food, focused on the manufacturing of dry extruded pet food. While no formal FDA 483 Inspectional Observations were issued, the inspection highlighted three key areas for discussion with management. These included observations regarding scale calibration records, where scales used for specific weight ranges (e.g., 5-10 pounds) were calibrated for a different range, lacking correlation with their operational use. Additionally, it was noted that monitoring records were signed only on the cover of compiled documents, rather than individually. Lastly, supply chain preventive control monitoring records were found not to be reviewed by a Preventive Controls Qualified Individual (PCQI). Management was cooperative, and the Quality and Food Safety Manager acknowledged the discussions, stating she would report these items to the corporate team for internal consideration. No voluntary corrections were deemed necessary during the inspection, and no samples were collected.