A consent decree against Gold Star Distribution for holding food in insanitary conditions has been issued by the FDA and the U.S. District Court for the District of Minnesota. The company distributed FDA regulated products including food, drugs, medical devices, and cosmetics.
The FDA observed persistent insanitary conditions, including severe rodent and pest infestations that put these products at high risk of potential contamination with filth.
Elizabeth Miller, Pharm.D., FDA associate commissioner for inspections and investigations said in a statement, “Consumers trust that the products they purchase — whether food, medicine, or everyday household items — have been stored safely and are free from contamination. When a company repeatedly ignores serious, ongoing violations that put trust at risk, the FDA will act. This consent decree makes clear that persistent failure to maintain basic sanitary conditions is unacceptable and will have consequences.”
The FDA inspected the company’s facility on five separate occasions, and the Minnesota Department of Agriculture inspected it on 26 occasions between 2013 and 2025. The insanitary conditions were associated with rodents, including observations of live and dead rodents, gnaw marks, package damage, rodent excrement, and nesting materials throughout the facility.
Rodents can carry pathogens including Salmonella, Listeria monocytogenes, and E. coli. Products contaminated with those pathogens can cause serious illness and can also compromise the safety, strength, quality, and purity of drugs.
The FDA also observed leaking and overflowing refuse near outgoing shipments of FDA-regulated products. There were also gaps and holes in the facility’s infrastructure, ceiling leaks dripping onto stored products, and trash buildup outside in the facility’s food and refuse containers.
The Minnesota Department of Agriculture twice issued a notice of embargo and cease and desist order covering all food products and operations in November 2025. The MDA also revoked the defendants food wholesale license. In December 2025, the Minnesota Board of Pharmacy issued a cease and desist order against the company for warehousing and distributing over the counter drugs without a required pharmacy license. Gold Star voluntarily recalled some FDA regulated products in 2025.
Before they can reopen, the company must retain an independent expert to develop and implement FDA-approved sanitation control, eliminate all pests and filth, complete renovations to prevent pest entry, destroy all FDA-regulated products in their possession under FDA supervision, and undergo comprehensive inspections by the FDA, an independent pest control company, and an independent expert.
