FDA Policy/General

FDA Consent Decree Against Gold Star Distribution

A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operator from receiving, storing or distributing FDA-regulated products until it corrects persistent insanitary conditions, including severe rodent and pest infestations that placed drugs, medical devices, food, and cosmetics at risk of contamination. The action follows repeated FDA and Minnesota Department of Agriculture (MDA) inspections documenting insanitary conditions at the company's Minneapolis warehouse.

A Minnesota federal judge signed the 9/21 order that applies to Gold Star and its owner, Bassam Abu Samrah, prohibiting them from handling FDA-regulated products at any current or future location until they comply with federal requirements and the terms of the decree.

During a 2025 inspection, FDA investigators observed nine live rodents, 17 dead rodents in various states of decay, eight live birds, one dead bird and five live worms throughout the facility, an agency release says. Investigators also documented rodent excrement, urine stains, gnaw holes and nesting materials in and around pallets containing FDA-regulated products, including rice, cat food, drugs, sanitary pads and cosmetics. FDA laboratory analyses confirmed the presence of rodent urine, urea, excrement, hair and gnaw holes in product packaging.

Additional violations included leaking and overflowing refuse near outgoing shipments, structural openings that could permit pest entry, ceiling leaks dripping onto stored products and accumulated trash outside the facility.

According to FDA, the agency inspected the warehouse five times before its 2025 inspection, while MDA conducted 26 inspections between 2013 and 2025. Many of those inspections documented recurring rodent-related insanitary conditions.

The Department of Justice, acting on FDA's behalf, alleged that Gold Star violated the Federal Food, Drug, and Cosmetic Act by holding products under conditions that could cause contamination with filth or render them injurious to health. The complaint also alleged that drugs stored at the facility were adulterated because they were not maintained in accordance with current good manufacturing practice requirements.

Under the consent decree, Gold Star must retain an independent expert to develop and implement FDA-approved sanitation and drug storage plans, eliminate pests and filth, and renovate its facilities to prevent future infestations. The company must also destroy all FDA-regulated products in its possession under FDA supervision and undergo inspections by independent experts, a pest control company and FDA, as deemed necessary.

Operations cannot resume until FDA provides written notification that the defendants appear to be in compliance with GMP requirements.

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