FDA EIR - M.I. Industries, Inc. dba Nature"s Variety - March 03, 2021

M.I. Industries, Inc., operating as Nature's Variety at its Lincoln, NE facility (FEI: 3014761942), underwent a comprehensive, routine surveillance inspection by the FDA from March 2-3, 2021. The inspection, conducted by the FDA Office of Human and Animal Food Operations Division II West, adhered to Compliance Program Guidance Manual 7371.000 for Comprehensive Animal Food Inspection, and reviewed the firm's compliance with the Federal Food, Drug, and Cosmetic Act, including aspects of 21 CFR 507 Subpart F regarding preventive controls for animal food. The facility manufactures raw frozen and freeze-dried pet food under the Instinct brand. Key areas reviewed included the firm's hazard analysis, food safety plan, preventive control monitoring, cleaning and sanitation, environmental monitoring, and pest control programs. Notably, the inspection concluded without the issuance of an FDA Form 483, "Inspectional Observations," indicating no significant violations were identified during this visit. While no official violations were cited, the report documented the firm's established procedures for handling several consumer complaints, including those alleging pet illness or foreign material, and discussed previous environmental monitoring results that occasionally showed positives for Salmonella spp. and Listeria monocytogenes, which were not linked to finished product contamination. As no official observations were issued, no specific regulatory actions were mandated by the FDA. Firm management received a general reminder of their ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act. The firm had, however, voluntarily initiated a review of their product donation process in response to some complaints.