FDA EIR - Mars Petcare US Inc - January 23, 2023

An FDA inspection of Mars Petcare US Inc. in Columbus, OH, was conducted from January 9 to January 23, 2023. The unannounced, comprehensive inspection of the low-acid canned food (LACF) pet food manufacturer reviewed compliance with regulations including 21 CFR Part 507 (Current Good Manufacturing Practice and Preventive Controls for Food for Animals), 21 CFR Part 113 (Thermally Processed Low-Acid Foods), and 21 CFR Part 108 (Emergency Permit Control). The inspection revealed several issues. A formal observation (FDA-483) was issued because a qualified container closure inspection person failed to record observations of can top seams with sufficient frequency, specifically lacking documentation for visual checks on January 9, 2023. Additionally, two significant issues were discussed: the firm did not adequately identify and evaluate all known or reasonably foreseeable hazards in its food safety plan, such as drug residues, and incorrectly documented its mycotoxin control as a supply chain control rather than in-house testing. Furthermore, sanitation control procedures were found to be inadequate, as corrective actions for failed sanitation swab analyses, such as re-cleaning, were not documented. Mars Petcare management was advised of potential FDA classifications and actions. They were encouraged to submit a written response to the FDA-483 within 15 business days. The firm also refused to allow photography during the inspection.