FDA EIR - Mars Petcare US - March 03, 2023

An FDA inspection of Mars Petcare US in Mattoon, IL, took place from February 22 to March 3, 2023. This comprehensive inspection focused on the manufacturing of kibble pet food and extruded pet treats for dogs and cats, partly in response to consumer complaints. The regulatory framework for the inspection included 21 CFR Part 507, covering Current Good Manufacturing Practice and Preventive Controls for Food for Animals, as well as 21 CFR 589.2000 concerning Bovine Spongiform Encephalopathy (BSE) regulations.

The inspection involved a detailed review of the firm's Food Safety Plan, hazard analysis, preventive controls, employee training, production records, recall procedures, and consumer complaint investigations. Specific attention was given to mycotoxin monitoring of raw materials and the environmental sampling program for Salmonella. Despite reviewing several consumer complaints, including those alleging pet illnesses, the firm's internal investigations and the FDA's review did not reveal any process deviations or significant issues during this inspection.

Critically, the FDA did not issue an FDA-483, which means no inspectional observations or significant violations were identified. Therefore, no specific required actions were mandated by the FDA as a result of this inspection. Discussions with management at the closing meeting reinforced the importance of the consumer complaint system, mycotoxin sampling procedures, and sanitation controls in post-extrusion product handling areas.