Silver Spring, MD, Sept. 23, 2026 (GLOBE NEWSWIRE) — A U.S. Food and Drug Administration investigation resulted in a federal court order, dated Sept. 21, 2026, stopping a warehouse operator from distributing FDA-regulated products including food, drugs, medical devices, and cosmetics until it fixes its operations to meet federal legal requirements.

The U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction against Gold Star Distribution, Inc., a Minnesota-based multi-commodity warehouse operator, and its owner, Bassam Abu Samrah, after the FDA observed persistent insanitary conditions, including severe rodent and pest infestations, that put food, drugs, medical devices, and cosmetics at risk of potential contamination with filth.

“Consumers trust that the products they purchase — whether food, medicine, or everyday household items — have been stored safely and are free from contamination,” said Elizabeth Miller, Pharm.D., FDA associate commissioner for inspections and investigations. “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.”

Among other requirements, the consent decree prohibits Gold Star and Abu Samrah, and their associated persons, from receiving, holding for sale, or distributing food (including human and animal foods, dietary supplements, and infant formula), drugs, medical devices and cosmetics at or from any current or future location unless and until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), federal regulations, and the decree.

The complaint, filed by the U.S. Department of Justice on behalf of the FDA, states that Gold Star and Abu Samrah violated the FD&C Act by causing food, drugs, medical devices, and cosmetics to become adulterated, while such products were held for sale in the Gold Star facility after shipment in interstate commerce, in that such products were held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.

In addition, the complaint states that Gold Star and Abu Samrah violated the FD&C Act by causing drugs to become adulterated because such products were not stored in accordance with current good manufacturing practice requirements for drugs.

The FDA and the Minnesota Department of Agriculture (MDA), in collaboration with other state regulatory partners including the Minnesota Board of Pharmacy, investigated persistent insanitary conditions at Gold Star’s warehouse facility in Minneapolis.

Prior to the 2025 inspection, the FDA inspected the Gold Star facility on five separate occasions. The MDA inspected the facility on 26 separate occasions between 2013 and 2025. FDA’s prior inspections, and many MDA inspections, cited insanitary conditions associated with rodents, including observations of live and dead rodents, gnaw marks, package damage, rodent excrement, and nesting materials throughout the facility. The FDA and MDA took several regulatory and compliance actions during this time to protect consumers.

Rodent and pest infestations in facilities that store food, drugs, medical devices, and cosmetics pose serious contamination risks. Rodents can carry pathogens such as Salmonella, Listeria, and E. coli, and their droppings, urine, and fur can contaminate such products, potentially causing illness or injury to consumers. Insanitary storage conditions also can compromise the safety, strength, quality, and purity of drugs. FDA-regulated products stored under these conditions are adulterated within the meaning of the FD&C Act.

In November and December 2025, the FDA conducted a follow-up inspection and observed continuing insanitary conditions, including nine live rodents, 17 dead rodents in various states of decay, eight live birds, one dead bird, and five live worms throughout the facility, as well as numerous rodent excreta pellets, urine stains, gnaw holes, and nesting materials in and around pallets of FDA-regulated products, including rice, cat food, drugs, sanitary pads, and cosmetics. The FDA’s laboratory analyses confirmed the presence of rodent urine, urea, excreta, hairs, and gnaw holes in product packaging.

In addition, the FDA observed leaking and overflowing refuse near outgoing shipments of FDA-regulated products; gaps and holes in the facility’s infrastructure; ceiling leaks dripping onto stored products; and trash buildup outside the facility door and refuse container.

In November 2025, the MDA twice issued a notice of embargo and cease and desist order covering all food products and operations. 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 defendants for warehousing and distributing over-the-counter drugs without a required pharmacy license and administratively detained the over-the-counter drugs held at the facility. Following the FDA’s 2025 inspection, Gold Star voluntarily recalled certain FDA-regulated products that may have been contaminated with filth.

The consent decree also requires the defendants to retain an independent expert to develop and implement FDA-approved sanitation control and drug storage plans; eliminate all pests and filth from the facility; complete facility renovations to prevent future pest entry; destroy all FDA-regulated products in their possession under FDA supervision; and undergo comprehensive inspections by an independent expert, an independent pest control company, and the FDA, as it deems necessary, before they may resume operations. Defendants must receive written notification from the FDA that they appear to be in compliance before resuming operations.

The FDA remains committed to ensuring all entities that receive, store, and distribute FDA-regulated products comply with federal food and drug safety laws and maintain sanitary conditions that protect consumers.  

Contact Info

U.S. Food and Drug Administration
FDAPressAlerts@fda.hhs.gov
+1 202-690-6343


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