Sunday, October 4, 2026

 

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Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions

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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.  

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FDA Issues Warning Letters Following Fungal Contamination in a Veterinary Product Linked to Serious Infections in Nearly 100 Horses

 

FDA Issues Warning Letters Following Fungal Contamination in a Veterinary Product Linked to Serious Infections in Nearly 100 Horses

At least 20 of the horses had to be humanely euthanized

September 29, 2026

The U.S. Food and Drug Administration recently issued warning letters to Neogen Corporation and Sciarra Aeromed, Inc., following an investigation that linked a veterinary wound care product labeled as sterile, Neogen Vet HYCOAT (hyaluronate sodium sterile solution), to serious infections and deaths in horses. This incident involved at least 20 horse deaths, making it the largest number of horse deaths ever associated with a quality defect in an FDA-regulated veterinary medical product and the most deaths of any animal species linked to microbiological contamination of an FDA-regulated product labeled as sterile. Neogen initiated a voluntary recall of HYCOAT in late January 2026.

Total fatalities reflect only those deaths reported to the FDA. The total number of affected horses only includes cases reported to the FDA with sufficient identification to confirm each as a unique case. To date, the FDA has not been informed of the final case outcome for many of the injured horses.

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 The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals. The two individuals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution scheme. The U.S. Food and Drug Administration’s Office of Criminal Investigations assisted with this investigation.

“Infiltrating the American drug supply with counterfeit products isn’t just a crime — it’s also a direct threat to public health and patient safety,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “The FDA will continue to trace illicit networks wherever they lead, across borders and through complex supply chains, to ensure that anyone who seeks to profit off counterfeit medicines face accountability — all in our mission to keep Americans safe.”

According to court documents, between July 2023 and April 2024, Roy and Ramancha allegedly obtained counterfeit Ozempic from unauthorized sources in China. The counterfeit Ozempic allegedly distributed by Roy, Ramancha, and their co-conspirators included counterfeit packaging, package inserts, pen labels, and needles meant to deceive downstream customers, including pharmacies and patients, into believing they were receiving authentic, manufacturer-authorized Ozempic. The indictment alleges that Roy, Ramancha, and their co-conspirators sold the counterfeit Ozempic to other co-conspirators and distributors in the U.S. at deeply discounted prices.

The FDA issued public safety alerts starting in December 2023 to warn consumers, pharmacies, and healthcare providers about counterfeit Ozempic products. Notably, court documents allege that Roy, Ramancha, and their co-conspirators continued distributing counterfeit Ozempic even after FDA’s December 2023 seizure and public warning.

The agency takes reports of possible counterfeit medicines seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to the FDA. Suspected counterfeit products may be reported by going to Report a problem to the FDA. 

An indictment is merely an allegation. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.


Found at FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme | FDA

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